The Online Seminar shows the Possibilities of the use of Desktop-Sharing Software. The Online-Seminar is free of charge an will contain the following topic.
How to Setup the Software.
Cost of the Software
Usage in the Sales and Marketing area.
The Webinar will held on request\, the duration is approx. 30 Minutes
Further Information to the Online-Seminar
END:VEVENT BEGIN:VEVENT DTSTAMP;VALUE=DATE-TIME:20130521T192400Z DTSTART;VALUE=DATE-TIME:20120402T220000Z DTEND;VALUE=DATE-TIME:20120724T213000Z UID:http://www.webinarcentral.net/content/business-mastery-series URL;VALUE=URI:http://www.webinarcentral.net/content/business-mastery-series SUMMARY:Business Mastery Series DESCRIPTION:Learn more\: www.practicepaysolutions.com/mastery
Join us for a free series of one-hour webinars with the a team of industry experts! We're presenting the less-covered\, critical issues for small business owners\, so you can reduce the time you spend on set-up and administration-- and focus on what really matters.
Can't attend live? We'll send you the call recordings so you can access valuable information and share the event with your community!
April 2nd\: The Joy of Productivity with George Kao
April 16th\: How to Create Profitable Referral Partnerships with Robert Notter
April 24th\: Say Bye-Bye to Your Boring Bio with Nancy Juetten
May 15th\: From Contacts to Contracts with Caterina Rando
May 22nd\: Red Fire Profitability with Liz Goodgold
June 5th\: Developing Contracts &\; Service Agreements with Tasha Cooper Coleman
June 19th\: Outsourcing Secrets with Travis Greenlee
July 10th\: Your Money Relationship = Your Business Success with Helen Kim
July 24th\: How to Play a Bigger Marketing Game with Fabienne Fredrickson
END:VEVENT BEGIN:VEVENT DTSTAMP;VALUE=DATE-TIME:20130521T192400Z DTSTART;VALUE=DATE-TIME:20120417T150300Z DTEND;VALUE=DATE-TIME:20120814T150300Z UID:http://www.webinarcentral.net/content/play-therapy-webinar-series URL;VALUE=URI:http://www.webinarcentral.net/content/play-therapy-webinar-series SUMMARY:Play Therapy Webinar Series DESCRIPTION:Allan Gonsher and Kids Inc are pleased to a offer a series of Play Therapy Webinars. If your work with children\, or want to work with children\, these are workshops that you can not afford to miss. Each webinar workshop offers one hour of continuing education credit.
END:VEVENT BEGIN:VEVENT DTSTAMP;VALUE=DATE-TIME:20130521T192400Z DTSTART;VALUE=DATE-TIME:20120706T160000Z DTEND;VALUE=DATE-TIME:20120706T173000Z UID:http://www.webinarcentral.net/content/managing-glp-studies-non-glp-facilities-webinar-complianceonline URL;VALUE=URI:http://www.webinarcentral.net/content/managing-glp-studies-non-glp-facilities-webinar-complianceonline SUMMARY:Managing GLP Studies in Non-GLP Facilities - Webinar By ComplianceOnline DESCRIPTION:This 90-minute webinar will help you understand when a new product being developed begins to fall under the umbrella of a regulated study\, teach you the basic principles of GLP study to better separate regulated activities from basic research\, provide practical tips on how to keep GLP-related materials separate from non-GLP materials\, and manage equipment designated for GLP use.
Why Should You Attend\:
An increasing number of companies and universities are running GLP studies or study phases in facilities that have never before been part of a regulated environment. Performing a GLP study in a non-GLP facility presents special challenges. If these challenges are not addressed properly\, parts of a study might be non-compliant\, increasing the risk of study rejection. This presentation describes the obvious challenges in running GLP studies in labs where non-GLP and other unrelated experimentation occurs. It offers tips on how to manage and separate GLP activities from non-GLP activities.
Areas Covered in the Seminar\:
- What constitutes a GLP study?
- What are the biggest risks in mixing GLP and non-GLP work in the same facility?
- How to separate GLP from non-GLP reagents
- How to keep test articles and reference standards away from non-GLP
- How to divide labs into GLP and non-GLP zones
- How to identify testing facility management
- How to train graduate students\, interns\, etc.\, in GLP
- What goes into the compliance statement when non-GLP activities are part of a GLP study?
Barefoot running is the newest running fad! Join us and find out why and how it can prevent running injuries and learn what types of footwear
are most appropriate to begin a safe barefoot running program.
Full Description\:
This webinar outlines the biomechanics of barefoot running and demonstrates how this type of running may prevent running-related injuries. We
will discuss footwear that is appropriate for barefoot running and participants will be provided with a program designed to safely begin
barefoot running.
Course Includes\:
Live Q&\;A
Presentation Handout
Post session recording access
CE Credit
What You Will Learn\:
Discuss how the biomechanics of barefoot running are different from traditional heel striking
Determine how barefoot running will unload certain body tissues and improve posture to prevent running injuries
Identify which types of footwear are most appropriate for barefoot running
Examine how to safely begin a barefoot running program
Your Presenter\:
Jonathan E. Gallas\, PT\, DPT\, CSCS\, is a licensed Physical Therapist and Certified Strength and Conditioning Specialist with 9 years of
experience rehabilitating runners\, 20 years of competitive running experience\, and 5 years of triathlon experience. Dr. Gallas is the facility
manager at Accelerated Rehabilitation Centers in Belvidere\, Illinois. He specializes in rehabilitation of orthopedic and sports injuries\, and
treats runners from many local running groups. He currently provides rehabilitation services to two high schools in Belvidere. Dr. Gallas
received his master's and doctorate degrees in Physical Therapy from St. Ambrose University in Davenport\, Iowa. Dr. Gallas is currently in the
dissertation phase of his doctorate in Physical Therapy from Nova Southeastern University in Ft. Lauderdale\, Florida.
Disclaimer\:
This event qualifies for one CE credit. Only registered attendees will have access to CE. A Cross Country Education web account is required to
attend. There is no charge for a CCE web account. It is recommended that you join the meeting 15 to 20 minutes early. Speaker phone sound
quality is poor and it is recommended that they not be used to listen to the event.
Technical requirements\:
To view this webinar you will need to download the WebEx Application. You will be prompted to download it when you first enter the site. To save time\, you can setup prior to the meeting by following this link\: https\://apidemoeu.webex.com/apidemoeu/meetingcenter/mcsetup.php
Who Should Attend\:
Physical Therapists\, Physical Therapist Assistants\, Athletic Trainers\, Exercise Physiologists\, Certified Strength and Conditioning Specialists\, Personal Trainers\, Fitness Professionals\, Podiatrists\, Orthotists
Acquire conceptual understanding\, tools and strategies that can help your company make informed export marketing decisions and set your products or services apart from competition.
At the end of this webinar you should be able to\:
• Learn on how to conduct export market research
• Understand the most common pricing methods and strategies
• Examine distribution strategies\; direct and indirect exporting
• Find qualified buyers\, agent or distributors
• Understand E- exporting and trade leads
This webinar will benefit\:
• Those with a product suitable for exporting\, but no previous exporting experience.
• Those with some export experiences\, but are seeking to expand their exporting knowledge.
• Export Managers\, and Supervisors (good refresher!)
• Private organizations with export related activities banks\, insurance and shipping companies.
• Entrepreneurs and trade consultants.
• Professional organizations - trade and industry associations\, Chamber of Commerce’s.
No password\, use of web browser only! No dial in required you will use your computer speakers. You may e-mail your questions in advance to stcintL@stcinternational.us
You may e-mail your questions in advance to stcintL@stcinternational.us
Event Date\: Friday\, July 6\, 2012
Event Link\: http\://www.gvolive.com/conference\,78353144
Cost\: Free
Time\: 11\:00 AM PST - 12\:00 AM MST - 1\:00 PM CST - 2\:00 PM EST
For future schedules please go to http\://www.stcinternational.us
END:VEVENT BEGIN:VEVENT DTSTAMP;VALUE=DATE-TIME:20130521T192400Z DTSTART;VALUE=DATE-TIME:20120710T020000Z DTEND;VALUE=DATE-TIME:20120710T020000Z UID:http://www.webinarcentral.net/content/big-data-analytics-and-bpm URL;VALUE=URI:http://www.webinarcentral.net/content/big-data-analytics-and-bpm SUMMARY:Big Data analytics and BPM DESCRIPTION:IT-directors\, data analysts and business users should join this session to learn more about what the current and future trends are regarding use of data integration management and analytics.
Your business is changing. Whether it’s growing\, re-inventing\, merging or acquiring\, one thing is certain\: data integration management has never been more complex than it is today.
Additionally\, various viewspoints on data and business process management and how to benefit from a modern\, high value Business Analytics solution are being discussed.
Speakers\: Pentaho
END:VEVENT BEGIN:VEVENT DTSTAMP;VALUE=DATE-TIME:20130521T192400Z DTSTART;VALUE=DATE-TIME:20120710T131000Z DTEND;VALUE=DATE-TIME:20120710T131000Z UID:http://www.webinarcentral.net/content/gxp-computer-system-validation-investigators-point-view-webinar-globalcompliancepanel URL;VALUE=URI:http://www.webinarcentral.net/content/gxp-computer-system-validation-investigators-point-view-webinar-globalcompliancepanel SUMMARY:GxP Computer System Validation\, The investigator's Point of View - Webinar By GlobalCompliancePanel DESCRIPTION:Overview\: The webinar explains what is needed to prepare for an audit or regulatory inspection. It addresses SOPs for the GxP and IT infrastructure\, hardware and software qualification\, computer system validation\, and change control for revalidation. This event is applicable to regulated companies and software vendors.
Areas Covered in the Session\:
Which data and systems require validation and which do not?
What the regulations mean\, not just what they say.
Evaluate the regulatory requirements related to the current computer system standards for security\, data transfer\, audit trails\, and electronic signatures.
SOPs required for compliance.
How to avoid 483 and Warning Letters.
What has to be qualified?
What has to be validated? Developer vs. user validation models.
Maintain compliance with change control for revalidation.
Who Will Benefit\:
IT
QA
QC
Laboratory staff
Managers
GMP\, GCP\, GLP professionals
This HR Risk Management training will cover compliance \\"Hot Spots\\" where HR professionals need to be especially vigilant in times of complex labor laws\, changing environments and workforce reorganization.
Why Should You Attend\:
Human Resources should be especially vigilant in times of complex labor laws\, changing environments and reorganization of the workforce. Responsibility lies heavily on Human Resources professionals to anticipate any areas which might present problems or liability for an organization. They must also take proactive measures to assure their organization has equitable and effective management and the correct talent necessary to advance the organization and execute its business plan.
This webinar will cover auditing human resources practices for compliance and liability to help identify and correct any areas that may not comply with applicable laws and/or do not comply with company policy. This action not only is a means to perform \\"due diligence\\" for your company\, but is a measuring tool to determine what needs to be improved to achieve a higher standard of excellence.
Areas Covered in the Seminar\:
This webinar assesses the current state of HR audits\, reviews some of the leading HR audit tools\, discusses the development of internal audit tools\, and reviews the development of an HR audit plan.
Why Should You Attend\:
Organizations looking to create a “risk-aware culture\,” must be proactive in identifying\, assessing\, and managing human capital risks\, must be able to link human capital risks and the benefits of HR management activities to financial statement\, and focus on the value created by human capital risk management.
Can your HR audit tools provide assurance that your organization's\:
This webinar will assess the current state of HR audits\, review some of the leading HR audit tools\, discuss the development of internal audit tools\, and review the development of an HR audit plan.
Learning Objectives\:
Webinar attendees will develop a working knowledge of HR audits\, be able to assess HR audit tools\, and be able to assist in planning and implementing an HR audit.
Areas Covered in the Seminar\:
In December 2010 the FDA began a project to better understand the industry’s adherence (or lack thereof) to 21 CFR Part 11. This involves the add on’ surveillance inspections of the sponsors’ computer systems during the course of the FDA’s regular inspections. This presentation will cover the scope\, status and results of the surveillance inspections and what they may mean for the future of 21 CFR Part 11.
Why should you Attend\:
In December 2010 FDA started the Part 11 inspection initiative. While originally the initiative was supposed to last 3-6 months\, it has now turned into an ongoing program with Part 11 related issues being part of most future inspections.
At the beginning of the initiative FDA made it very clear that Part 11 is in effect and is enforced according to the original Part 11 and the Guidance from 2003.
In the meantime FDA officials reported about key findings. For example\, George Smith who heads up FDA's Part 11 working group gave an update with examples of violations. This webinar will enable you to determine whether your company is subject to the most common violations so you can take action to have a better inspection outcome.
Areas Covered in the Session\:
- What is FDA's most current thinking related to computers and electronic records?
- What are the inspection trends?
- What are most frequent recent citations for Part11?
- What are the most frequent deviations for computer system validation?
- Under which circumstances can inspectors exercise enforcement discretion?
- How important is risk based Part11 compliance?
- What is the best strategy for future proven Part 11 compliance?
Webinar Includes\:
Q/A Session with the Expert to ask your question
PDF print only copy of PowerPoint slides
90 Minutes Live Presentation
Who will Benefit\:
* Everybody using computers in FDA regulated environments
* IT manager and staff
* QA managers and personnel
* Regulatory affairs
* Training departments
* Consultants
* Validation specialists
About Speaker
Angela Bazigos has been accepted into the prestigious ranks of Stanford Who’s Who as a result of her remarkable work in the biotechnology industry. Throughout her brilliant professional career\, Angela has routinely exhibited the passion\, vision and dedication necessary to be successful in the business world.
Angela Bazigos is the CEO of Touchstone Technologies Silicon Valley\, Inc. “Your Passport to Compliance”. She has 30 years experience in the Life Sciences industry spanning project management\, Quality Assurance and Regulatory Affairs. She has applied for patents aimed at speeding up Software Compliance and FDA Audits.
Angela is a member SQA (Society of Quality Assurance) as well as of the SQA CVIC (Computer Validation Initiative Committee)\, DIA and RAPS. She provides consulting services to Pharma\, Biotech\, Medical Device and CRO industries on compliance matters\, including strategy\, submissions\, quality assurance\, computer systems validation\, and remediation’s following action by the FDA. She also teaches classes on Compliance\, 21 CFR 11\, Computer Systems Validation\, and Project Management.
More recently\, Ms. Bazigos co-authored Computerized Systems in Clinical Research\, Current Data Quality and Data Integrity Concepts with FDA\, DIA and Academia. She is also on the board for UC Berkeley’s Haas Business School for Executive Education in Life Sciences.
Barefoot running is the newest running fad! Join us and find out why and how it can prevent running injuries and learn what types of footwear
are most appropriate to begin a safe barefoot running program.
Full Description\:
This webinar outlines the biomechanics of barefoot running and demonstrates how this type of running may prevent running-related injuries. We
will discuss footwear that is appropriate for barefoot running and participants will be provided with a program designed to safely begin
barefoot running.
Course Includes\:
Live Q&\;A
Presentation Handout
Post session recording access
CE Credit
What You Will Learn\:
Discuss how the biomechanics of barefoot running are different from traditional heel striking
Determine how barefoot running will unload certain body tissues and improve posture to prevent running injuries
Identify which types of footwear are most appropriate for barefoot running
Examine how to safely begin a barefoot running program
Your Presenter\:
Jonathan E. Gallas\, PT\, DPT\, CSCS\, is a licensed Physical Therapist and Certified Strength and Conditioning Specialist with 9 years of
experience rehabilitating runners\, 20 years of competitive running experience\, and 5 years of triathlon experience. Dr. Gallas is the facility
manager at Accelerated Rehabilitation Centers in Belvidere\, Illinois. He specializes in rehabilitation of orthopedic and sports injuries\, and
treats runners from many local running groups. He currently provides rehabilitation services to two high schools in Belvidere. Dr. Gallas
received his master's and doctorate degrees in Physical Therapy from St. Ambrose University in Davenport\, Iowa. Dr. Gallas is currently in the
dissertation phase of his doctorate in Physical Therapy from Nova Southeastern University in Ft. Lauderdale\, Florida.
Disclaimer\:
This event qualifies for one CE credit. Only registered attendees will have access to CE. A Cross Country Education web account is required to
attend. There is no charge for a CCE web account. It is recommended that you join the meeting 15 to 20 minutes early. Speaker phone sound
quality is poor and it is recommended that they not be used to listen to the event.
Technical requirements\:
To view this webinar you will need to download the WebEx Application. You will be prompted to download it when you first enter the site. To save
time\, you can setup prior to the meeting by following this link\: https\://apidemoeu.webex.com/apidemoeu/meetingcenter/mcsetup.php
Who Should Attend\:
Physical Therapists\, Physical Therapist Assistants\, Athletic Trainers\, Exercise Physiologists\, Certified Strength and Conditioning Specialists\,
Personal Trainers\, Fitness Professionals\, Podiatrists\, Orthotists
END:VEVENT BEGIN:VEVENT DTSTAMP;VALUE=DATE-TIME:20130521T192400Z DTSTART;VALUE=DATE-TIME:20120710T190400Z DTEND;VALUE=DATE-TIME:20120710T200400Z UID:http://www.webinarcentral.net/content/last-chance-register-best-practices-preparation-behavior-during-and-response-fda-inspection- URL;VALUE=URI:http://www.webinarcentral.net/content/last-chance-register-best-practices-preparation-behavior-during-and-response-fda-inspection- SUMMARY:Last Chance to Register on Best Practices for Preparation for\, Behavior during\, and Response to an FDA Inspection By compliance2go DESCRIPTION:Does the FDA call in advance or just show up at my door? Where do I let the inspector go? Do I give them a tour? What should I let them see? Who should I let them talk to? Are they ever going to leave? The FDA inspection is the most nerve-wracking event in the life of a regulatory professional - you're in charge of compliance\, usually in the background\, and NOW you're in the spotlight\, and if your performance isn't good\, it's not the show that may close\, it's YOUR COMPANY! However\, adequate planning\, training\, composure\, and understanding should result in many encore presentations! This session will discuss how to prepare for the inspection\, what to do during the inspection and the close-out interview\, and how to respond to the inspection. Also contained in this session will be the limits of FDA's scope during an inspection\, including what documents you are not required to show them\, and the permissibility of photographs and affidavits
Areas Covered in the Session\:
How to prepare for an FDA inspection
Development and contents of an SOP for FDA inspection
Personnel training before inspection
How to behave during an inspection
Limitations of scope of inspection
Response to investigation findings
FDA guidance documents used by their inspectors
Webinar Includes\:
-Q/A Session with the Expert to ask your question
-PDF print only copy of PowerPoint slides
-60 Minutes Live Presentation
Who will benefit\: The designations
This webinar will provide valuable assistance to all companies that market in the U.S.\, since they are by definition subject to FDA regulation\, in the Medical Device\, Diagnostic\, Pharmaceutical\, and Biologics fields. The employees who will benefit include\:
Executive/senior management
Regulatory management
QA management
Any personnel who may have direct interaction with FDA officials
Consultants
Quality system auditors
About Speaker
Jeff Kasoff\, RAC\, is the Director of Quality at Byrne Medical\, a leading manufacturer of endoscopy products. In this position\, Jeff is responsible for supplier management\, during which he oversees supplier management\, CAPA\, and document control. Prior to this\, Jeff spent 13 years at Life-Tech as the Director of Regulatory Affairs\, where he was responsible for regulatory compliance of all aspects of the quality system. Jeff received his regulatory affairs certification in 1996.
END:VEVENT BEGIN:VEVENT DTSTAMP;VALUE=DATE-TIME:20130521T192400Z DTSTART;VALUE=DATE-TIME:20120711T131000Z DTEND;VALUE=DATE-TIME:20120711T131000Z UID:http://www.webinarcentral.net/content/good-documentation-practices-gmp-operations-webinar-globalcompliancepanel-0 URL;VALUE=URI:http://www.webinarcentral.net/content/good-documentation-practices-gmp-operations-webinar-globalcompliancepanel-0 SUMMARY:Good Documentation Practices for GMP Operations - Webinar By GlobalCompliancePanel DESCRIPTION:Overview\: Whether you work in production or in a laboratory or if you conduct investigations or finalize product release\, sound data and information is essential to success and compliance. To ensure success and avoid those frustrating\, embarrassing discussions of missing or doubtful data\, laboratory employees must follow good documentation practices.
According to the FDA\, if it isn't written down\, it didn't happen. As well\, if it isn’t written down clearly\, it didn’t happen either. GMP compliance (21CFR\, Part 211) requires the use of good documentation practices. These practices apply to all pharmaceutical manufacturing and support areas. Good Documentation Practices describe the required activities and steps to use when recording data and other handwritten entries. Personnel who work with documentation must be informed of these requirements\, recognize their significance to their job and be aware of the consequences of non-compliance. During this 1-hour webinar\, we will review the Good Documentation Practices plus demonstrate examples of these practices (both good and bad!) as they apply to the pharmaceutical arena.
Why you should attend\: The Learning Objectives of this presentation include\:
Discover what the regulations say about documentation practices
Learn what your signature and/or initials mean on a document
See how to correct errors and omissions in data entry
Learn \\"Do's\\" and \\"Don'ts\\" of documentation practices
Learn how to attach raw data to records
Review rounding and limit expression determinations
Areas Covered in the Session\:
21CFR Part 211 and Eudralex references to documentation
Correcting errors and omissions
Dates and formats
Meanings of initials and signatures
Use of \\"NA\\"
Comments and explanations
Handling raw data (charts\, strips\, printouts)
Blanks
Entering numerical data.
Who Will Benefit\:
Production personnel (operators\, supervisors)
Laboratory personnel (chemists\, technicians\, supervisors)
Batch record reviewers
QA Auditors of Production and Laboratory Documents
Validation\, Engineering
Maintenance personnel (mechanics\, supervisors)
Warehousing personnel
This GAMP® 5 training/Webinar will discuss on the GAMP® software validation model and the defined process of GAMP® 5 as it applied to FDA software validation.
Why Should You Attend\:
Many companies struggle with understanding what FDA\, MHRA\, EU and other Ministries of Health want to see regarding software validation.This presentation will review the FDA validation process\, the GAMP® software validation model\, and the process defined in GAMP® 5 as it applies to FDA software validation. The attendee should leave the presentation confident in their ability to understand and apply the GAMP® 5 process.
- FDA inspectors are now being trained to evaluate software validation practices.
- Increasing use of automated manufacturing and quality systems means increased exposure
- Most recalls can be traced back to computerized equipment\, exposing the validation process to scrutiny
- Corporate uncertainty leads to inaction and 'wheel spinning'
- A third of recent warning letters included citations with respect to improper or ineffective validation
Join us Wednesday\, July 11\, 2012 from10\:00 to11\:00 a.m. EST for an interactive webinar. During this webinar you will have a chance to learn how to protect and license your products\, and meet the evolving needs of your customers through an extensive array of licensing models and features.
Be sure to register at https\://www4.gotomeeting.com/register/854141303!
END:VEVENT BEGIN:VEVENT DTSTAMP;VALUE=DATE-TIME:20130521T192400Z DTSTART;VALUE=DATE-TIME:20120711T180000Z DTEND;VALUE=DATE-TIME:20120711T180000Z UID:http://www.webinarcentral.net/content/art-therapy-and-anxiety-disorders-4 URL;VALUE=URI:http://www.webinarcentral.net/content/art-therapy-and-anxiety-disorders-4 SUMMARY:Art Therapy and Anxiety Disorders DESCRIPTION:This webinar is designed to educate participants about art therapy and provide practical skills for effective assessment and intervention with
clients experiencing symptoms of anxiety.
Full Description\:
This webinar is designed to educate participants about art therapy and provide practical skills for effective assessment and intervention with
clients experiencing symptoms of anxiety. Demonstrations of art therapy techniques will advance the participants’ understanding of the bio
psychosocial perspective of many of the disorders that fall under the category of “anxiety\,” including phobias\, PTSD\, panic\, as well as sleeping
and eating disorders. Significant attention will be paid to treatment interventions with numerous opportunities for hands-on art-based
techniques.
Course Includes\:
Live Q&\;A
Presentation Handout
Post session recording access
CE Credit
What You Will Learn\:
1.Discover an alternative method of communicating with clients suffering with anxiety—including PTSD\, Phobias\, Acute Stress\, Eating Disorders\,
Sleep Disorders\, and Panic Attacks
2.Identify effective Art Therapy techniques and learn how to implement them in session
3.Examine the therapeutic power that art provides in reducing stress and understanding fears
4.Acquire skills for assessing and treating anxiety
5.Discuss various art tasks and experience the healing process to promote coping skills in life
Your Presenter\:
Pamela M. Hayes\, MFT\, LMHC\, ATR-BC\, is an artist and a registered and board certified Art Therapist. She is licensed as a Marriage and Family
Therapist and Mental Health Counselor and is currently in private practice in Los Angeles\, California. Ms. Hayes developed the art therapy
program at the Rhode Island School of Design. For the past 15 years\, Ms. Hayes has worked in numerous psychiatric settings. Currently\, her focus
includes families\, couples\, adults\, and children struggling with mood and anxiety disorders\, addiction\, eating disorders\, abuse\, and grief-
related issues. Ms. Hayes has an undergraduate degree in Fine Arts from Parsons School of Design in New York City and a graduate degree in
Marriage and Family Therapy and Art Therapy from Notre Dame de Namur University in Belmont\, California. For more information about Ms. Hayes\,
please visit her website at\: www.hayesarttherapy.com.
Disclaimer\:
This event qualifies for one CE credit. Only registered attendees will have access to CE. A Cross Country Education web account is required to
attend. There is no charge for a CCE web account. It is recommended that you join the meeting 15 to 20 minutes early. Speaker phone sound
quality is poor and it is recommended that they not be used to listen to the event.
Technical requirements\:
To view this webinar you will need to download the WebEx Application. You will be prompted to download it when you first enter the site. To save
time\, you can setup prior to the meeting by following this link\: https\://apidemoeu.webex.com/apidemoeu/meetingcenter/mcsetup.php
Who Should Attend\:
Marriage and Family Therapists\, Licensed Professional Counselors\, Social Workers\, Psychiatric Nurses\, Drug and Alcohol Abuse Counselors\,
Pediatricians\, Physicians\, Art Therapists\, Pastoral Counselors\, Guidance Counselors\, Youth Pastors\, Youth Counselors\, Educators
END:VEVENT BEGIN:VEVENT DTSTAMP;VALUE=DATE-TIME:20130521T192400Z DTSTART;VALUE=DATE-TIME:20120711T183000Z DTEND;VALUE=DATE-TIME:20120711T200600Z UID:http://www.webinarcentral.net/content/last-chance-register-integrating-pharma-supply-chain-according-fda-expectations-compliance2g URL;VALUE=URI:http://www.webinarcentral.net/content/last-chance-register-integrating-pharma-supply-chain-according-fda-expectations-compliance2g SUMMARY:last Chance to Register on INTEGRATING THE PHARMA SUPPLY CHAIN ACCORDING TO FDA EXPECTATIONS By compliance2go DESCRIPTION:Successful companies in leading sectors tend to exhibit a common characteristic – they employ supply chains that are integrated in terms of both physical flow of materials and information. This allows them to build cultures and quality systems that continuously improve the ways they do business and deliver value to their customers. The pharmaceutical industry\, for reasons which are made clear in the webinar\, has not placed the same importance on the supply chain and is now suffering the consequences.
The main thrust of the session will be towards understanding what those successful companies (from industries such as semiconductor\, automotives and aerospace) did to achieve integrated supply chains\, how they continue to do it and what benefits they derive. It starts with the design &\; development stage\, where supply chain foundations are laid and explores how supply chain management (SCM) competencies can and should be applied at this critical stage. Then it examines how SCM must permeate the organization for the full life-cycle of the product. The modernization initiates from FDA and ICH are translated into the language on modern production systems (such as Toyota Production System - TPS) and a plan for moving from what the Lean experts call a ‘process village’ to a value stream alignment is outlined. Finally\, the session will pull together a cohesive account of the necessary cultural and organizational changes that must take place at both industry and company level to ensure sustainable supply chain performance improvement\; this will be perfect ammunition to help talk to others within your organization to start a dialogue for change……….
Areas Covered in the Session\:
· What the regulators (FDA/EMA/MHRA) are demanding of industry to increase supply chain integrity and control.
· The role of drug development (CMC) as a critical enabler of supply chain performance
· The power of supply chain management (SCM) when it integrates strategic procurement\, production and inventory control\, transportation and storage\, information systems and improvement methodologies.
· How to build\, manage and perfect the supply chain using Lean and Systems Thinking
· What you need to do the convince senior management of the need for change
· Driving meaningful change for the better (Kaizen)
Webinar Includes\:
Q/A Session with the Expert to ask your question
PDF print only copy of PowerPoint slides
90 Minutes Live Presentation
Who will benefit\: (Titles)
· Research chemistry and biochemistry
· Chemical and biochemical engineering
· Chemistry\, manufacturing\, and controls
· Preclinical development
· Clinical development
· Regulatory affairs
· Quality assurance
· Finance
· Marketing
· Informatics and information systems
· Business development
· Licensing
· Pharmacovigilance
· Purchasing
· Procurement
· Supply management
· Operations
· Production management
· Inventory management and control
· Production and material planning
· Demand planning
· Logistics
· Warehouse management
· Import/export
· SCM
· General management
· Investors – VCs &\; private equity
· Lawyers
Why should you attend?
The Pharmaceutical supply chain is in trouble as never before. Supply chain shortages in the US have moved even the President to demand urgent remediation\; high level congressional committees (eg the Health\, Education\, Labor and Pensions Senate Committee –HELP) have also asked searching questions of FDA and other involved stakeholders\, in an attempt to discover what has been going on with high profile supply chain failures. Companies such as J &\; J and Novartis are also writing off hundreds of millions worth of cost due to much publicized manufacturing issues.
Cargo theft\, diversion and counterfeiting have become almost endemic\, with detection and enforcement efforts stretched to the limit. Finally\, and possibly most worrying of all\, are the cases where materials have been adulterated or substituted with toxic alternatives (for economic gain) and have progressed undetected through one or more stages in the supply chain causing eventual patient death.
So what has gone wrong and how will it all pan out? We have to trace back to the 1970’s\, when outsourcing of manufacture and distribution began in earnest\; this was followed by a move towards off-shoring of key intermediates\, APIs and even drug product. The result is we now have the most dis-integrated supply chain any industry sector has ever known. Without urgent remediation at the grass roots level\, things are set to stay the same.
This webinar will provide attendees with a clear understanding of where the issues lay\, and provide a structured road map to steer a path to move your supply chain to a new level of performance in terms of quality\, cost and performance. This is achieved by exploring ways of working that move away from the mass production paradigm towards patient focused value streams
About Speaker
Hedley Rees is a practising consultant\, coach and trainer\, helping healthcare companies build\, manage and continuously improve their clinical trial and commercial supply chains and risk profiles. He has his own company\, Biotech PharmaFlow Ltd\, based in the UK and handles assignments across the spectrum from top ten Pharma’s through to highly virtual early stage start ups. Prior to this\, Hedley held senior supply chain positions at Bayer\, British Biotech\, Vernalis\, Johnson &\; Johnson and OSI Pharmaceuticals. His skill set covers the range of supply chain management processes from strategic procurement\, production and inventory control\, distribution logistics\, information systems and improvement. His specific interest is in driving industry improvements through the regulatory modernization frameworks of FDAs 21st Century Modernization and ICH Q8 – Q10.Hedley holds an Executive MBA from Cranfield University School of Management and is a corporate member of the Chartered Institute of Purchasing and Supply (MCIPS). He is a member of the UK BioIndustry Association’s (BIA) Manufacturing Advisory Committee and also regularly speaks at international conferences\, being co-chair of the 2011 FDA/Xavier University sponsored Global Outsourcing Conference in Cincinnati\, October 2 -5. He has published in US and EU pharmaceutical journals and is author of “Supply Chain Management in the Drug Industry\: Delivering Patient Value for Pharmaceuticals and Biologics” published by J. Wiley &\; Sons\, Hoboken\, New Jersey.
END:VEVENT BEGIN:VEVENT DTSTAMP;VALUE=DATE-TIME:20130521T192400Z DTSTART;VALUE=DATE-TIME:20120711T220000Z DTEND;VALUE=DATE-TIME:20120711T231500Z UID:http://www.webinarcentral.net/content/hplc-outside-box-how-think-chromatographer-webinar-complianceonline URL;VALUE=URI:http://www.webinarcentral.net/content/hplc-outside-box-how-think-chromatographer-webinar-complianceonline SUMMARY:HPLC Outside the Box\: How to Think Like a Chromatographer - Webinar By ComplianceOnline DESCRIPTION:This webinar on verification of compendial methods will give a good understanding of the revised USP Chapter <\;1226>\; and FDA requirements and provide recommendations and tools for effective implementation.
Why Should You Attend\:
Compendial methods such as USP and EP standards are validated by the organizations that have developed and published the method. The FDA requires users of such methods to demonstrate the user's competence to successfully run the method. For example\, 21 CFR 211.194 (a) states\: The suitability of all testing methods used shall be verified under actual conditions of use. However\, the FDA does not give any further guidance on what\, when and how. And the first revision of USP <\;1226>\; did not have specific recommendations. But FDA inspectors go out and write 483's and warning letters related to <\;1226>\;. Now USP has announced to come out with a new revision using the risk based approach for the type and extend of testing.
This webinar will give a good understanding of USP and FDA requirements and provide recommendations and tools for effective implementation.
Hand-Outs\:
For easy implementation\, attendees will receive
Note\: These complimentary hand-outs will be sent to customers on request. Please email customercare@complianceonline.com for these documents\, stating your order number\, and they will be emailed to you within 4 working days.
END:VEVENT BEGIN:VEVENT DTSTAMP;VALUE=DATE-TIME:20130521T192400Z DTSTART;VALUE=DATE-TIME:20120712T131000Z DTEND;VALUE=DATE-TIME:20120712T131000Z UID:http://www.webinarcentral.net/content/effective-training-practices-fda-compliance-webinar-globalcompliancepanel URL;VALUE=URI:http://www.webinarcentral.net/content/effective-training-practices-fda-compliance-webinar-globalcompliancepanel SUMMARY:Effective Training Practices for FDA Compliance - Webinar By GlobalCompliancePanel DESCRIPTION:Overview\: No or inadequate training of employees is one of most frequently cited deviations in FDA inspectional observations and warning letters. Trainings are either not planned\, not conducted\, not evaluated or not documented as expected by inspectors. On the other hand it has been is estimated that about 5% of employee's time is spent for training. So there seems to be lack of understanding on what the regulations are\, their interpretations and expectations of inspectors.
This webinar will give a good understanding of FDA requirements for training and provide recommendations for implementation.
Reference material for easy implementation\:
Primer\: Successful compliance training (20 pages)
SOP\: Training for GMP Compliance
SOP\: Training for GxP\, 21 CFR Part 11 and Computer Validation
Areas Covered in the Session\:
GxP training requirements in US and EU
Most frequently cited deviations
Developing an effective training program for a company\, site or department.
Developing a training plan for individual employees
Who can or should be responsible for the training program and training plans.
Most efficient training tools for different tasks.
Assessment of successful participation
The benefits of risk based training
Documentation of trainings for the FDA
Specific training requirements for Part 11.
Who Will Benefit\:
Training departments
QA managers and personnel
Analysts and lab managers
Validation specialists
Regulatory affairs
Human resources (HR) managers and staff
Documentation department
Consultants
This 90-minute webinar will focus on the critical steps in starting up a new cleanroom operation and releasing it for manufacturing. It includes a case study-based approach to dealing with excursion events and establishing control of the cleanroom after a worst case event.
Why Should You Attend\:
This webinar will focus on starting up a new cleanroom operation covering from utilities to environmental monitoring. Routine cleaning and disinfection will also be addressed. Addressing contamination and bringing up the cleanroom after a worst case even will be discussed. Cases studies on bringing up the site after a worst case event will be discussed in detail. Excursion investigations will also be discussed and troubleshooting parameters and suggestions will be discussed.
Areas Covered in the Seminar\:
- The critical steps needed to release the room for manufacturing will be discussed.
- Routine Cleaning and Disinfection Strategies will be covered as well as the latest in equipment and application.
- Establishing control of the cleanroom after a worst case event.
- Excursion events will be discussed and case studies will be covered regarding excursion events.
This Clinical trial auditing training will provide an understanding of how to conduct compliant and successful clinical trials by defining FDA clinical trial audit procedures\, audit program\, audit planning and audit preparation.
Why Should You Attend\:
The field of GCP has rapidly evolved over the last few years and the requirements are getting tougher. Many companies find themselves unprepared for a clinical trial audit\, either at a clinical site or their headquarters.
This course will help you to prepare early and help to prevent surprises when being audited. Learn to identify risks and handle them to build a more compliant and successful trial.
This training will also share the ”audit experience”\, by sharing what auditors look for and how to prepare for the visit. Define expectations\, train your staff and hold them accountable and the inspection will be easy to manage. We will describe proactive measures you can take to assure that all systems are in place\, operating well and operating in compliance.
Areas Covered in the Seminar\:
This webinar explores Social Anxiety Disorder\, or Social Phobia\, and its relationship to other disorders via assessment\, treatment\, and
prevention\, as well as how to help improve the personal\, financial\, and social life of clients.
Full Description\:
This webinar is designed to create awareness for Social Anxiety Disorder\, aka Social Phobia\, an often debilitating and overlooked\, yet
treatable\, condition. Based on current research\, this course provides the most up-to-date information on diagnosis\, assessment\, and treatment of
Social Anxiety Disorder and its relationship to other anxiety disorders. Attendees will leave the webinar with a renewed awareness of the
personal\, financial\, and social costs of this significant public health problem.
Course Includes\:
Live Q&\;A
Presentation Handout
Post session recording access
CE Credit
What You Will Learn\:
Recognize the personal\, financial\, and social challenges associated with Social Anxiety Disorder
Examine the co-morbidities associated with Social Anxiety Disorder including substance abuse\, depression\, and other anxiety disorders
Differentiate Social Anxiety Disorder from other common anxiety disorders in a differential diagnosis
Discuss the benefits and obstacles of using Cognitive-Behavioral Therapy (CBT) as treatment
Your Presenter\:
Kimberly Morris\, PhD\, HSPP\, is a licensed psychologist with over 18 years of experience in clinical psychology. In addition to practicing at St.
Joseph Hospital\, Dr. Morris currently teaches psychology courses at Indiana University in Kokomo\, Indiana.
Dr. Morris received her doctorate in clinical psychology from Indiana University in Bloomington\, Indiana. She also completed a postdoctoral
appointment at the University of Pittsburgh in Behavioral Weight Control. While in Pittsburgh\, she developed a special interest in the treatment
of depression and anxiety disorders using a Cognitive-Behavioral approach.
Disclaimer\:
This event qualifies for one CE credit. Only registered attendees will have access to CE. A Cross Country Education web account is required to
attend. There is no charge for a CCE web account. It is recommended that you join the meeting 15 to 20 minutes early. Speaker phone sound
quality is poor and it is recommended that they not be used to listen to the event.
Technical requirements\:
To view this webinar you will need to download the WebEx Application. You will be prompted to download it when you first enter the site. To save
time\, you can setup prior to the meeting by following this link\: https\://apidemoeu.webex.com/apidemoeu/meetingcenter/mcsetup.php
Who Should Attend\:
Psychologists\, Social Workers\, Licensed Professional Counselors\, Marriage and Family Therapists\, Psychiatric Nurses\, Psychiatric Nurse
Practitioners\, Case Managers\, Alcoholism and Drug Abuse Counselors/Addiction Professionals\, Clergy
END:VEVENT BEGIN:VEVENT DTSTAMP;VALUE=DATE-TIME:20130521T192400Z DTSTART;VALUE=DATE-TIME:20120712T200000Z DTEND;VALUE=DATE-TIME:20120712T204000Z UID:http://www.webinarcentral.net/content/free-lunch-learn-webinar-microsoft-office-2010-tips-tricks URL;VALUE=URI:http://www.webinarcentral.net/content/free-lunch-learn-webinar-microsoft-office-2010-tips-tricks SUMMARY:Free Lunch & Learn Webinar\: Microsoft Office 2010 Tips & Tricks DESCRIPTION:Space is limited
Reserve your Webinar Seat Now! https\://www3.gotomeeting.com/register/512688566
Complimentary Lunch &\; Learn Webinar\: Microsoft Office 2010 Tips &\; Tricks
Thursday\, July 12\, 2012 12\:00 PM - 12\:40 PM Pacific Time
This session is ideal for users who have recently upgraded to Microsoft Office 2010\, and who want to get up to speed quickly and learn valuable tips to save time\, create user-friendly documents\, present information in a compelling way\, and analyze data with ease. We will start with the overall Office 2010 navigation and options\, and then move to PowerPoint to demonstrate themes and layouts\, then to Excel to see some of the powerful lists and reports capabilities\, and end with Word for some styles and formatting tips.
What you will be able to do as a result\:
-Become familiar with the Office 2010 navigation and options
-Learn new PowerPoint\, Excel\, and Word techniques that will help you become more effective in creating and managing your documents
-Save time on a daily basis
About the Presenter\:
Kim Silverman\, VP of Productivity at People-OnTheGo\, is a dynamic\, result-driven professional with more than 15 years experience in the consulting\, training\, and development fields. Kim masterfully helps everyone from “technology challenged” individuals to advanced power users to rapidly learn and implement the Accomplishing More with Less Methodology\, and use a variety of applications including Microsoft Outlook\, Excel\, Word\, PowerPoint\, Total Organization and more. Kim holds a Master’s degree in Applied Behavioral Science specializing in Consulting and Training.
Hope you will be able to join us!
END:VEVENT BEGIN:VEVENT DTSTAMP;VALUE=DATE-TIME:20130521T192400Z DTSTART;VALUE=DATE-TIME:20120712T190000Z DTEND;VALUE=DATE-TIME:20120712T200000Z UID:http://www.webinarcentral.net/content/last-chance-register-update-and-look-ahead-fda%E2%80%99s-changes-510k-process-compliance2go URL;VALUE=URI:http://www.webinarcentral.net/content/last-chance-register-update-and-look-ahead-fda%E2%80%99s-changes-510k-process-compliance2go SUMMARY:Last chance to register on Update On and Look Ahead At FDA’s Changes to the 510(k) Process By compliance2go DESCRIPTION:Why should you attend \:
As the vast majority of moderate risk medical devices are cleared for marketing through the 510(k) process\, these changes can have a substantial impact on the way industry does business. This presentation will discuss the background behind FDA’s decision to modify the 510(k) process\, outline the progress it has made in 2011and 2012 to implement these changes\, and take a look at what changes are yet to come in 2012 and beyond.
Webinar Includes\:
Q/A Session with the Expert to ask your question
PDF print only copy of PowerPoint slides
90 Minutes Live Presentation
Description of the topic \:
In 2010\, FDA issued a report on the changes it plans to make to the 510(k) process to address regulatory\, industry\, and consumer concerns and 2011 and 2012 have been marked by the agency’s progress in implementation of these changes. In the past year\, the agency published a draft guidance document that revises and clarifies the agency’s longstanding policies regarding when a new 510(k) submission will be required for changes being made to an existing device and another draft guidance document which creates a second alternate de novo pathway for devices found to be not substantially equivalent (NSE) at the end of the 510(k) process.
FDA has also issued a draft guidance document which would change and clarify other aspects of the agency’s 510(k) program in an attempt to foster more consistency across 510(k) reviews\, coupled with training and certification for FDA device reviewers. Other 510(k)-related guidance documents have issued as well.
Who will benefit\:
Representatives of manufacturers and marketers of 510(k) medical devices\, including in-house counsel\, outside FDA counsel\, regulatory affairs personnel\, and regulatory consultants.
About Speaker
Mr. Evan P. Phelps is a principal at OFW Law. Mr. Phelps advises companies on compliance with Food and Drug Administration (FDA) law and regulations\, with focus on matters related to medical devices and biologics as well as those affecting Clinical Investigators.
Casper E. Uldriks \, counsel at OFW Law\, was born in Battle Creek\, Michigan . He began his 30+ year career as an investigator at FDA in 1978. He graduated with his B.A. in 1973 from Albion College\, his Master of Divinity from Boston University in 1976\, and his J.D. from Suffolk University Law School in 1986. He was admitted to the Massachusetts Bar in 1986 and the DC Bar in 2011. For years he has trained FDA staff on medical law and has been a featured speaker at many professional conferences involving FDA's medical device program.
This one-hour webinar is designed to educate participants on how to guide clients through the process of describing their art work in order to
understand patterns of behavior and ways to self-soothe.
Full Description\:
This webinar is designed to educate participants on how to ask open-ended questions to facilitate communication after clients have created the
art work. Precise questions to be asked of the client will be provided based on specific art techniques. Participants will be discouraged from
imposing their own interpretations on their clients’ art work and will be guided on how to get clients to open up when describing their art-
making experiences. This webinar will also provide specific techniques as well as the language needed to describe the directives. In addition\,
you will learn what questions to ask that will best evoke insight and understanding from the client regarding unconscious motivations\, patterns
of behavior\, and ways to self-soothe.
Course Includes\:
Live Q&\;A
Presentation Handout
Post session recording access
CE Credit
What You Will Learn\:
1.Discover an alternative method of communicating with clients
2.Examine effective Art Therapy techniques and learn how to implement them in session
3.Recognize the therapeutic power that art provides\, and how to affectively use the art as a means of communication
4.Identify skills for assessing and treating a multitude of clients
5.Discuss various art tasks and experience the healing process to promote coping skills in life
Your Presenter\:
Pamela M. Hayes\, MFT\, LMHC\, ATR-BC\, is an artist and a registered and board certified Art Therapist. She is licensed as a Marriage and Family
Therapist and Mental Health Counselor and is currently in private practice in Los Angeles\, California. Ms. Hayes developed the art therapy
program at the Rhode Island School of Design. For the past 15 years\, Ms. Hayes has worked in numerous psychiatric settings. Currently\, her focus
includes families\, couples\, adults\, and children struggling with mood and anxiety disorders\, addiction\, eating disorders\, abuse\, and grief-
related issues. Ms. Hayes has an undergraduate degree in Fine Arts from Parsons School of Design in New York City and a graduate degree in
Marriage and Family Therapy and Art Therapy from Notre Dame de Namur University in Belmont\, California. For more information about Ms. Hayes\,
please visit her website at\: www.hayesarttherapy.com
Disclaimer\:
This event qualifies for one CE credit. Only registered attendees will have access to CE. A Cross Country Education web account is required to
attend. There is no charge for a CCE web account. It is recommended that you join the meeting 15 to 20 minutes early. Speaker phone sound
quality is poor and it is recommended that they not be used to listen to the event.
Technical requirements\:
To view this webinar you will need to download the WebEx Application. You will be prompted to download it when you first enter the site. To save
time\, you can setup prior to the meeting by following this link\: https\://apidemoeu.webex.com/apidemoeu/meetingcenter/mcsetup.php
Who Should Attend\:
Marriage and Family Therapists\, Licensed Professional Counselors\, Social Workers\, Psychiatric Nurses\, Drug and Alcohol Abuse Counselors\,
Pediatricians\, Physicians\, Art Therapists\, Pastoral Counselors\, Guidance Counselors\, Youth Pastors\, Youth Counselors\, Educators
END:VEVENT BEGIN:VEVENT DTSTAMP;VALUE=DATE-TIME:20130521T192400Z DTSTART;VALUE=DATE-TIME:20120713T130000Z DTEND;VALUE=DATE-TIME:20120713T190000Z UID:http://www.webinarcentral.net/content/navigating-japan-regulatory-and-clinical-trial-environment-conducting-clinical-studies-japa-1 URL;VALUE=URI:http://www.webinarcentral.net/content/navigating-japan-regulatory-and-clinical-trial-environment-conducting-clinical-studies-japa-1 SUMMARY: Navigating the Japan Regulatory and Clinical Trial Environment\; Conducting Clinical Studies in Japan - Webinar By ComplianceOnline DESCRIPTION:This Japan Regulatory and Clinical Trial Requirements training will cover Japan Regulatory Agency Structure and Responsibilities\, its review process for decision-making and approval\, requirements for clinical trials in Japan and the procedures for conducting clinical studies in the country and reporting them.
Why Should You Attend\:
This 6 hour virtual seminar will help you gain a comprehensive understanding of the Regulatory Structure\, Clinical Trial Requirements and the Conduct of Running Clinical Research in Japan. It will prepare you for the regulatory approval processes\, Agency meetings\, the complexities of running studies in Japan\, the importance of partner selection and add the cultural knowledge needed for success. The recent changes made by PMDA to be more sponsor-friendly will be reviewed. Real world experiences on actual interactions with the Agency since these changes\, will also be discussed.
Agenda\: (All time in EDT)
This 2-hr webinar will review the FDA and FTC regulations for promoting and advertising dietary supplements\, walk you through real-life case studies\, help you address compliance\, and tell you how to respond to an FDA enforcement action.
Why Should You Attend\:
FDA and FTC routinely initiate enforcement actions\, including Untitled Letters\, Warning Letters\, Recalls\, etc.\, against dietary supplement makers who misbrand their products by violating FDA advertising and promotion regulations\, e.g.\, by claiming the product can treat\, cure\, prevent\, mitigate or diagnose disease. Sometimes the Department of Justice gets involved and prosecutes firms on behalf of these agencies for violations. Such prosecutions often involve lawsuits against individuals running the companies\, and can lead to Consent Decrees for the companies and their owners and responsible corporate officers. These threats can be avoided with proper review of promotional materials and by training and educating staff.
This webinar will review the applicable regulations\, walk you through real-life case studies\, help you address compliance\, and tell you how to respond to an enforcement action. You will have opportunities to ask questions.
Learning Objectives\:
At the end of this presentation\, participants will
This 2-hour OSHA injury and illness recordkeeping training will teach you how OSHA analyzes recordkeeping scenarios by focusing on those concepts and rules that are most commonly misunderstood by recordkeepers and their bosses
Why Should You Attend\:
OSHA injury and illness recordkeeping remains a point of emphasis and a focus of enforcement for OSHA. Although the rules have been in effect since 2002\, employers continue to struggle to understand how to apply the rules. Record keepers and their bosses tend to try to apply common sense or Workers’ Compensation rules which result in a misunderstanding of how OSHA interprets its recordkeeping rules.
In this 2-hour webinar\, we will help you understand the OSHA recordkeeping analysis and show how you can avoid the pitfalls that lead to citations. This will by achieved by focusing on the recordkeeping concepts that are most frequently misunderstood.
Areas Covered in the Seminar\:
During this one-hour webinar we will discuss human neuropsychological development in infants\, the many interacting factors\, and how emotions shape the way the cortical systems exert control over limbic areas.
Full Description\:
Human neuropsychological development involves interacting factors\: The unfolding of complex dynamic\, dyadic systems\, the movement of external regulation inward toward internal regulation and experience-dependent right-hemisphere maturation where caregivers support infant brain development. Allan Schore writes\, “I believe that every type of early-forming\, primitive\, emotional disorder involves the right Orbitofrontal Cortex.” In this way\, emotions shape the way high-level cortical systems exert control over lower limbic areas.
Course Includes\:
Live Q&\;A
Presentation Handout
Post session recording access
CE Credit
What You Will Learn\:
Learn that early human neuropsychological development is centered upon experience dependent maturation\, leading to a self-regulatory system within the infant
Discuss the views of Allan Schore\: early-forming\, emotional disorders involve the right hemisphere Orbitofrontal Cortex
Understand the interaction of positive and negative emotional systems\, which are essential for neurodevelopment
Examine the reasons why the sympathetic nervous system guides neurodevelopment
Identify the role of the parasympathetic system in neurodevelopment
Your Presenter\:
ANITA REMIG\, Ed.D.\, F.P.P.R.\, F.S.M.I.\, is a practicing clinical psychologist\, certified school psychologist and consultant with over 25 years of experience specializing in learning styles\, brain-based research and learning problem interventions. Dr. Remig is a member of the American Psychological Association. She is a “Fellow of the Prescribing Psychologist Register” (F.P.P.R.) and a “Fellow in Serious Mental Illness” (F.S.M.I.) from the Prescribing Psychologist Register. Dr. Remig also recently passed the ICCP National Examination for Psychologists in Psychopharmacology and has been awarded a certification as a Medical Psychologist from the Academy of Medical Psychology.
Disclaimer\:
This event qualifies for one CE credit. Only registered attendees will have access to CE. A Cross Country Education web account is required to attend. There is no charge for a CCE web account. It is recommended that you join the meeting 15 to 20 minutes early. Speaker phone sound quality is poor and it is recommended that they not be used to listen to the event.
Technical requirements\:
To view this webinar you will need to download the WebEx Application. You will be prompted to download it when you first enter the site. To save time\, you can setup prior to the meeting by following this link\: https\://apidemoeu.webex.com/apidemoeu/meetingcenter/mcsetup.php
Who Should Attend\:
Psychologists\, Psychiatrists\, Social Workers\, Counselors\, Case Managers\, Educators\, Marriage &\; Family Therapists\, Drug and Alcohol Counselors\, Physicians\, Nurses\, Criminal Justice Personnel (Probation Officers)\, Parents
Overview\: This webinar will start by covering ways to understand the physical properties of our formulated products through the use of very specialized analytical techniques.
The information obtained from these specialized studies is critical in developing optimized lyophilization cycles and formulations without having to use a \\"trial and error\\" approached\, which is still commonly used by many companies who don’t understand the science behind freeze-drying. Next\, webinar will focus on using what was learned above to develop an optimized\, cGMP compliant formulation that is specifically designed for lyophilization. In depth discussions will be included on a pre-formulation assessment\, pre-formulation studies including choosing an optimal solution pH and buffer system\, solubility enhancement\, controlling oxidation\, and bulking agents. Additionally\, time will be dedicated to tying everything learned from the pre-formulation studies into designing an optimal formulation tailored specifically for our molecule of interest. Finally\, the webinar will conclude with a discussion on the specialized aspects of designing a formulation for large\, biomolecule formulations\, and the analytical techniques used drive this process.
Why you should attend\: Companies developing new formulations and lyophilization cycles must be able to explain\, scientifically\, why they have chosen each excipient they have added to a formulation\, why they are using as much as they have added\, what are the critical temperatures of the products (glass transition temperature\, Tg’ or eutectic melting temperature\, Te)\, etc. Companies that cannot produce this type of information run the risk of being delayed in getting their products approved and on the market\, which can have a dramatic impact on their profit margin. The topics described in this session will cover all of the aspects of understanding the justification for freeze-drying\, the thermal properties of the formulation (crystalline\, amorphous\, mixed)\, the analytical techniques employed to characterize these systems\, and how all of this information is used to develop a stable\, optimized\, cGMP compliant product. At the end of the session\, the attendee will be able to develop a well-defined process for taking an empirical approach to designing formulations and the lyophilization cycles used to dry them. By understanding and applying these principles\, companies have a much greater chance of getting products approved by the Regulatory agencies than those companies that employ the \\"trial and error\\" approach to formulation and lyophilization cycle design.
Areas Covered in the Session\:
Pre-formulation assessment
Selecting acceptable formulation components
Buffers and buffer capacity
Antioxidants\, stabilizers\, surfactants\, bulking agents\, complexing agents\, cosolvents
Crystalline vs. amorphous vs. mixed systems
Eutectic melting\, glass transition\, and collapse temperatures
Thermal characterization techniques
Filling and fill volume
Biomolecule stabilization theory
Excipient considerations
Infrared analysis of proteins
Learning objectives\:
Understanding the thermal properties of a formulation (crystalline\, amorphous\, mixed)
Understanding the critical temperatures (Tg’\, Te\, Tc) of a formulation
Understanding different excipients in formulations and how they affect the thermal properties
Understanding buffers and buffer systems\, bulking agents\, tonicity modifying agents\, anti-oxidants\, co-solvent systems and solubility enhancing techniques\, stabilizers\, surfactants\, and glass transition temperature modifying excipients
Understanding issues associated with large molecule (monoclonal antibodies\, globular proteins\, etc)formulation and freeze-drying.
Who Will Benefit\: This webinar will provide valuable assistance to those companies involved developing formulations and lyophilization cycles\, or in lyophilization product manufacturing. Those who would benefit from this webinar include\:
Quality Control Scientists
Development Scientists
Production Management
Quality Assurance
Overview\: This Webinar will provide a substantive overview and outline differences between the Technical File and Design Dossier for those device firms dealing with the global regulatory landscape. It is assumed that participants and customers have a prior CE Mark and Medical Device Directive background. The Technical File is a comprehensive collection of information and documents that details everything about your medical device.
Understanding how to assemble this information and present the information properly is essential. If you manufacture a Class I device\, a less complex CE Marking Technical File may be required. In the case of Class IIa\, IIb and Class III devices\, a more complex CE Technical File or Design Dossier must be prepared. EU Technical File construction is subject to review by a Notified Body if the medical device is Class I with measuring or sterile function\, Class IIa\, IIb\, and III (Design Dossier). Once placed on the market\, national Competent Authorities have the right to review EU Technical Files regardless of classification at any time. An incomplete or improperly completed Technical File may result in unexpected delays or even prevent market entry. Whereas the expression \\"Technical File\\" is usually associated with Class I\, IIa and IIb\, and \\"Design Dossier\\" for class III products.\, the files are retained on the premises of the manufacturer or the Authorized Representative for potential review of Competent Authorities and Notified Body. Dossiers have to be submitted to the Notified Body for review prior CE-Marking of your product. It is not necessary to include all documents in the design dossier which have already been subject to an ISO/MDD type Audit by the Notified Body. Examples of documents not necessary to be included are Quality Manuals and related lower-level documents. A brief summary of manufacturing processes (flow chart including inspection and preventive monitoring steps) and validation of sterilization processes should be included in the design dossier. Be prepared to review all elements that comprise these documents and address recommended best practices.
Areas covered in the session\:
Learn the differences between the Tech File and Dossier and why the construction phase is so important
Compile the EU Technical File or Design Dossier and ensure Format and Content expectations are addressed appropriately
Understand why Design Dossier is viewed as a subset of the Tech Documentation with emphasis on “design”
Determine exactly which materials need to be assembled
NB must examine the application for examination of the design dossier and\, if the product conforms to the relevant provisions of the Directive\, issue the application with an EC design-dossier certificate
Review all existing documentation in support of meeting the applicable Essential Requirements of the Directive(s)
Determine applicable standards and address company-specific SOPs for constructing and managing your files
European Norms and Standards and other documents supporting Technical Files and Design Dossiers
Guidance on Design-Dossier Examination and Report Content.
Who will benefit\: This webinar will provide valuable assistance and guidance to medical device companies responsible for constructing and managing their Technical Files and Design Dossiers. Employees who will benefit include\:
All levels of management and departmental representatives and those who desire a better understanding or a \\"refresh\\" overview\; however\, it is assumed that customers/attendees have some prior MDD and CE Mark background as applicable
Regulatory Affairs/Regulatory Affairs Specialists
Clinical Affairs
Quality and Compliance
Marketing &\; Sales
Distributors
Engineering/Technical Services
Consultants
This 21 CFR Part 11 compliance training will guide you through the concept of part 11 and explanation of its 3 primary areas SOPs\, Product features and Validation (10 step risk based approach).
Why Should You Attend\:
This webinar describes exactly what is required to be 21 CFR Part 11 compliant. It takes the concepts of Part 11 and expands them into specific things to do in all three primary areas\: SOPs\, product features\, and validation. All required IT SOPs are described. Product features based on the current industry standards are explained in detail. The 10-step risk-based validation approach is outlined so that the specific documents for a validation project are understood.
This is the first webinar in a series and it takes the mystery out of what is needed for 21 CFR Part 11 compliance. It will help you to eliminate 483s and Warning Letters.
Areas Covered in the Seminar\:
This Project Management training for Auditors will help you understand how to apply project management principles to auditing to ensure efficient and effective quality assurance of drug development.
Why Should You Attend\:
Auditing is essential to ensuring quality assurance of drug development. Each audit has a degree of complexity which needs effective project management. With ever increasing pressures to complete the audit promptly and to the appropriate quality standard\, the effective use of project management can provide essential tools and techniques to achieve this. Indeed effective project management can be a key factor to successful completion of efficient auditing.
This presentation will provide you with an excellent understanding of project management skills\, to apply to auditing in all GXP areas. You will be provided with an integrated project tool kit which can easily be used with your existing or future project management tools used for auditing. This tool kit has been used to significantly improve the successful completion of auditing on time to the right quality standard in many pharmaceutical organisations. The presentation will show you how to use these project management skills to gain the most benefit from them in your auditing activities.
Areas Covered in the Seminar\:
- What is a Project Management framework for auditing?
- What are the benefits and relevance of project management to audit?
- Key principles of project management applied to auditing
- key project management definitions relevant to audit
- Defining project scope and requirements for an audit project
- Developing the Project Work Plan for an audit
- Defining activity dependencies and creating network diagrams for an audit
During this one-hour webinar we will discuss human neuropsychological development in infants\, the many interacting factors\, and how emotions shape the way the cortical systems exert control over limbic areas.
Full Description\:
Human neuropsychological development involves interacting factors\: The unfolding of complex dynamic\, dyadic systems\, the movement of external regulation inward toward internal regulation and experience-dependent right-hemisphere maturation where caregivers support infant brain development. Allan Schore writes\, “I believe that every type of early-forming\, primitive\, emotional disorder involves the right Orbitofrontal Cortex.” In this way\, emotions shape the way high-level cortical systems exert control over lower limbic areas.
Course Includes\:
Live Q&\;A
Presentation Handout
Post session recording access
CE Credit
What You Will Learn\:
Learn that early human neuropsychological development is centered upon experience dependent maturation\, leading to a self-regulatory system within the infant
Discuss the views of Allan Schore\: early-forming\, emotional disorders involve the right hemisphere Orbitofrontal Cortex
Understand the interaction of positive and negative emotional systems\, which are essential for neurodevelopment
Examine the reasons why the sympathetic nervous system guides neurodevelopment
Identify the role of the parasympathetic system in neurodevelopment
Your Presenter\:
ANITA REMIG\, Ed.D.\, F.P.P.R.\, F.S.M.I.\, is a practicing clinical psychologist\, certified school psychologist and consultant with over 25 years of experience specializing in learning styles\, brain-based research and learning problem interventions. Dr. Remig is a member of the American Psychological Association. She is a “Fellow of the Prescribing Psychologist Register” (F.P.P.R.) and a “Fellow in Serious Mental Illness” (F.S.M.I.) from the Prescribing Psychologist Register. Dr. Remig also recently passed the ICCP National Examination for Psychologists in Psychopharmacology and has been awarded a certification as a Medical Psychologist from the Academy of Medical Psychology.
Disclaimer\:
This event qualifies for one CE credit. Only registered attendees will have access to CE. A Cross Country Education web account is required to attend. There is no charge for a CCE web account. It is recommended that you join the meeting 15 to 20 minutes early. Speaker phone sound quality is poor and it is recommended that they not be used to listen to the event.
Technical requirements\:
To view this webinar you will need to download the WebEx Application. You will be prompted to download it when you first enter the site. To save time\, you can setup prior to the meeting by following this link\: https\://apidemoeu.webex.com/apidemoeu/meetingcenter/mcsetup.php
Who Should Attend\:
Psychologists\, Psychiatrists\, Social Workers\, Counselors\, Case Managers\, Educators\, Marriage &\; Family Therapists\, Drug and Alcohol Counselors\, Physicians\, Nurses\, Criminal Justice Personnel (Probation Officers)\, Parents
Recently the software development world has seen the popularization of certain technologies that have added complexities in managing a company's software compliance process. These technologies include\:
* Cloud Computing
* Platform as a Service
* Software as a Service
* Distributed version control systems such as Git and Mercurial
* Increased build time dependencies such as Maven and Ruby Gems
Date and Time - Wednesday\, July 18\, 2012 at 11AM - 12PM IST
Presenters\:
Mark E. Tolliver\, CEO\, Palamida
Mark Tolliver brings more than 30 years of experience in the high-tech industry to his position as CEO of Palamida\, a San Francisco-based software company focused on software intellectual property management and compliance.
Jeff Luszcz\, V.P. Professional Services\, Palamida\, Inc
As Founder and VP of Services and Support\, Jeff leads the professional services team responsible for enterprise audits. He is also responsible for managing Palamida's field-engineering services\, assisting with product development and implementation and leading upcoming product release programs.
END:VEVENT BEGIN:VEVENT DTSTAMP;VALUE=DATE-TIME:20130521T192400Z DTSTART;VALUE=DATE-TIME:20120718T001100Z DTEND;VALUE=DATE-TIME:20120718T051200Z UID:http://www.webinarcentral.net/content/changing-compliance-needs-open-source-software URL;VALUE=URI:http://www.webinarcentral.net/content/changing-compliance-needs-open-source-software SUMMARY:The Changing Compliance Needs for Open Source Software DESCRIPTION:Recently the software development world has seen the popularization of certain technologies that have added complexities in managing a company's software compliance process. These technologies include\:
* Cloud Computing
* Platform as a Service
* Software as a Service
* Distributed version control systems such as Git and Mercurial
* Increased build time dependencies such as Maven and Ruby Gems
Date and Time - Wednesday\, July 18\, 2012 at 11AM - 12PM IST
Presenters\:
Mark E. Tolliver\, CEO\, Palamida
Mark Tolliver brings more than 30 years of experience in the high-tech industry to his position as CEO of Palamida\, a San Francisco-based software company focused on software intellectual property management and compliance.
Jeff Luszcz\, V.P. Professional Services\, Palamida\, Inc
As Founder and VP of Services and Support\, Jeff leads the professional services team responsible for enterprise audits. He is also responsible for managing Palamida's field-engineering services\, assisting with product development and implementation and leading upcoming product release programs.
END:VEVENT BEGIN:VEVENT DTSTAMP;VALUE=DATE-TIME:20130521T192400Z DTSTART;VALUE=DATE-TIME:20120718T160000Z DTEND;VALUE=DATE-TIME:20120718T170000Z UID:http://www.webinarcentral.net/content/what-every-fda-regulated-company-needs-know-about-its-fda-district-office URL;VALUE=URI:http://www.webinarcentral.net/content/what-every-fda-regulated-company-needs-know-about-its-fda-district-office SUMMARY:What Every FDA Regulated Company Needs to Know About its FDA District Office DESCRIPTION:This webinar will cover the responsibilities of FDA District Offices and provide practical tips on what you can do to ensure your firm stands a better chance to be viewed positively by your district office and the FDA generally.
Why Should You Attend\:
Any firm that expects to not have FDA regulatory issues must understand its District office and how the District Office plays such an important role. The FDA implements much of its authority to regulate food and health products for which it is responsible through its 26 district offices. The activities of district offices through inspections and other contacts with firms can well be instrumental in how the firm is regarded by the FDA\, with the result that decisions and field laboratories in the Centers and Offices at FDA headquarters may be impacted by recommendations and reports of the district office. FDA views firms it regulates as either “a player” or a “non-player. By having good relations with the FDA District Office a firm will be perceived as a “player.”
Areas Covered in the Seminar\:
- The organization of district offices within FDA regions
- The responsibilities of FDA District Offices.
- How District Offices are organized.
- Why not all District Offices have the same responsibilities.
- District Offices and FDA laboratories.
- The relationship between District Offices and the Centers at FDA.
- How agency politics can impact on FDA”s District Offices.
- Establishing a good relationship with the District Office.
- Maintaining a good relationship with the District Office.
As the focus on international product safety regulations increases\, life sciences organizations must globalize and enhance their safety and pharmacovigilance operations in order to successfully navigate through the challenges they are presented with.
Join BioPharm Systems' Dr. Rodney Lemery\, vice president of safety and pharmacovigilance\, for this free one-hour webinar that will discuss a major pharmaceutical company's pharmacovigilance globalization initiative that helped standardize and streamline its operations.
Several topics that will be discussed include\:
• SOP Integration
• Standardization of Local Practices
• Departmental Coordination
• Varying Reporting Requirements
To learn more about BioPharm Systems\, please visit http\://www.biopharm.com.
Wednesday\, July 18\, 2012 @\:
7\:00 a.m. US Pacific time
8\:00 a.m. US Mountain time
9\:00 a.m. US Central time
10\:00 a.m. US Eastern time
15\:00 UK time
16\:00 Central European time
This webinar will provide an introduction to the FDA’s regulation of Over-the-Counter (OTC) drug products and the various methods for bringing such a product to market. You will learn the various options for marketing an OTC drug\, gain an understanding of FDA’s relevant labeling and promotional rules\, and learn strategies for mitigating the potential risk for FDA regulatory enforcement.
Why Should You Attend\:
All OTC drugs are regulated by the U.S. Food and Drug Administration’s (“FDA”) and can enter the market in one of the following ways\: (a) by complying with an applicable monograph\; (b) as the subject of an FDA approved New Drug Application\; or (c) via an FDA approved Rx-to-OTC Switch.
Most of the OTC drugs available today are marketed and sold as OTC monograph drug products. Although still a very\, very small percentage of the total number of OTC drug products on the market\, the Rx-to-OTC Switch regulatory pathway is becoming increasingly popular for placing OTC drugs on the shelves as companies look for ways to extend the life cycle of their branded prescription products.
This webinar will provide beginners with an introduction to FDA’s regulation of OTC drug products. Some of the topics to be covered in this webinar include\:
* Whether a drug product can be marketed and sold as an OTC
* The various pathways for bringing an OTC drug to market
* The OTC Monograph process and the products currently covered by monographs
* Switching an Rx drug product to an OTC
* Rules for labeling and marketing an OTC drug product\, and
* Strategies for mitigating potential FDA regulatory risks based on recent Agency enforcement action.
Traditional approaches to digital marketing are no longer good enough!
The complexity and scale of managing global digital marketing has radically changed the way CMOs look at digital marketing. Marketing leaders need to find new ways to increase the speed and the quality of marketing insights\, execution\, measurement\, and reporting to drive market share and revenue growth.
This webinar explores a new model for data driven digital marketing and provides the insights into the tools and techniques to accelerate global digital marketing operations.
It will help you understand\:
Where your organization is on the data driven maturity model
How to get to the higher maturity stage as quickly as possible
How new solutions are enabling better efficiency\, effectiveness\, and ROI
A complimentary IDC Whitepaper\, sponsored by Infosys\, will be available to all attendees after the completion of webinar.
Bryant &\; Stratton College Online will host a free webinar\, \\"How the Electronic Health Record Impacts Today’s Healthcare Administrators” on Wednesday\, July 18\, from 12\:00 to 1\:00 p.m. EDT. The webinar will discuss the critical role the Electronic Health Record plays in a variety of healthcare settings including private practice\, facilities and hospitals.
The webinar will provide current and prospective students an overview of how the Electronic Health Record is maintained and used in facilitating patient care. Additionally\, Bryant &\; Stratton College Online Instructor Laura Soldani will answer questions about careers in the medical informatics field and the online degree programs at Bryant &\; Stratton College Online.
For more information and to register for the webinar\, please visit\: http\://online.bryantstratton.edu/webinar/
END:VEVENT BEGIN:VEVENT DTSTAMP;VALUE=DATE-TIME:20130521T192400Z DTSTART;VALUE=DATE-TIME:20120719T131000Z DTEND;VALUE=DATE-TIME:20120719T131000Z UID:http://www.webinarcentral.net/content/fda-inspection-process-sop-483-webinar-globalcompliancepanel URL;VALUE=URI:http://www.webinarcentral.net/content/fda-inspection-process-sop-483-webinar-globalcompliancepanel SUMMARY:The FDA Inspection Process\: From SOP to 483 - Webinar By GlobalCompliancePanel DESCRIPTION:Overview\: Does the FDA call in advance or just show up at my door? Where do I let the inspector go? Do I give them a tour? What should I let them see? Who should I let them talk to? Are they ever going to leave? The FDA inspection is the most nerve-wracking event in the life of a regulatory professional - you're in charge of compliance\, usually in the background\, and NOW you're in the spotlight\, and if your performance isn't good\, it's not the show that may close\, it's YOUR COMPANY! However\, adequate planning\, training\, composure\, and understanding should result in many encore presentations!
This session will discuss how to prepare for the inspection\, what to do during the inspection and the close-out interview\, and how to respond to the inspection. Also contained in this session will be the limits of FDA's scope during an inspection\, including what documents you are not required to show them\, and the permissibility of photographs and affidavits.
Areas Covered in the Session\:
How to prepare for an FDA inspection
Development and contents of an SOP for FDA inspection
Personnel training before inspection
Proper behavior during an inspection
Limitations of scope of inspection
Response to investigation findings
FDA guidance documents used by their inspectors
Who Will Benefit\: This webinar will provide valuable assistance to all companies that market in the U.S.\, since they are by definition subject to FDA regulation\, in the Medical Device\, Diagnostic\, Pharmaceutical\, and Biologics fields.
The employees who will benefit include\:
Executive/Senior Management
Regulatory Management
QA Management
Any personnel who may have direct interaction with FDA officials
Quality System Auditors
Consultants
Course Description \:-
Most medical devices marketed in the European Union must follow the Medical Device Directive (MDD)\; IVD device and active implantable devices have other directives. The MDD can be complicated\, especially for US companies\, because the MDD’s approach is different than the regulatory approach in the US. For example\, under the MDD your company makes “submissions” to a private company that you hire\, not to a government agency.
This interactive two-day course will help you comprehensively understand details of the MDD and implement its requirements. Attendees will learn how to classify devices\, select the appropriate conformity assessment path\, prepare the required documentation\, and maintain it. During the course\, participants will have exercises that apply the principles and help solidify learning.
The instructor addresses the details of the MDD and includes other significant issues such as the Quality Management System (ISO 13485)\, Risk Management (ISO 14971)\, Clinical Evaluation (MDD Annex X)\, and the role of harmonized standards.
Course Objectives \:-
Why Should You Attend\:
The FDA recently held hearings addressing drug companies' use of social media and other online platforms to advertise. FDA also released a guidance document about manufacturers’ obligation regarding off-label information available about their products. Another guidance document about use of social media in marketing is expected soon. In addition\, FDA issued several letters to manufacturers indicating the rules for using social media.
But there is still much confusion among FDA regulated companies how to use social media for marketing effectively and still be compliant with regulations.
Areas Covered in the Seminar\:
- How Direct-to-consumer-advertising (“DTCA”) guidance impacts the use of social media.
- Common ways companies are currently using social media.
- FDA advertising and promotion issues related to social media.
- A structure for analysis of responsibility for promotion in social media.
- Handling unsolicited requests for off-label information.
- Recent trends in FDA enforcement actions involving social media.
- Recent discussions about soc
This 90-minute webinar provide you a comprehensive understanding of HR policies that small companies need to have\, information on the number of employees you can have before you must have these policies in place\, and save you from penalties and fines.
Why Should You Attend\:
Any business\, even smaller units\, needs to have HR policies. Most business have someone employed or a vendor to handle government requirements that have to do with finances. But\, most often they fail to have anyone managing employee/ HR policies. Failure to do so can result in liabilities that can cost your business enormous sums of money in court settlements.
This 90-minute webinar is intended to provide you a comprehensive understanding of these policies\, information on the number of employees you can have before you must have these policies in place\, and save you from penalties and fines.
Learning Objectives\:
Understanding the threshold number of employees before various written human resource policies are required by an organization.
END:VEVENT BEGIN:VEVENT DTSTAMP;VALUE=DATE-TIME:20130521T192400Z DTSTART;VALUE=DATE-TIME:20120719T180000Z DTEND;VALUE=DATE-TIME:20120719T180000Z UID:http://www.webinarcentral.net/content/fda-inspection-process-sop-483-webinar-globalcompliancepanel-0 URL;VALUE=URI:http://www.webinarcentral.net/content/fda-inspection-process-sop-483-webinar-globalcompliancepanel-0 SUMMARY:The FDA Inspection Process\: From SOP to 483 - Webinar By GlobalCompliancePanel DESCRIPTION:Overview\: Does the FDA call in advance or just show up at my door? Where do I let the inspector go? Do I give them a tour? What should I let them see? Who should I let them talk to? Are they ever going to leave? The FDA inspection is the most nerve-wracking event in the life of a regulatory professional - you're in charge of compliance\, usually in the background\, and NOW you're in the spotlight\, and if your performance isn't good\, it's not the show that may close\, it's YOUR COMPANY! However\, adequate planning\, training\, composure\, and understanding should result in many encore presentations!
This session will discuss how to prepare for the inspection\, what to do during the inspection and the close-out interview\, and how to respond to the inspection. Also contained in this session will be the limits of FDA's scope during an inspection\, including what documents you are not required to show them\, and the permissibility of photographs and affidavits.
Areas Covered in the Session\:
How to prepare for an FDA inspection
Development and contents of an SOP for FDA inspection
Personnel training before inspection
Proper behavior during an inspection
Limitations of scope of inspection
Response to investigation findings
FDA guidance documents used by their inspectors
Who Will Benefit\: This webinar will provide valuable assistance to all companies that market in the U.S.\, since they are by definition subject to FDA regulation\, in the Medical Device\, Diagnostic\, Pharmaceutical\, and Biologics fields. The employees who will benefit include\:
Executive/Senior Management
Regulatory Management
QA Management
Any personnel who may have direct interaction with FDA officials
Quality System Auditors
Consultants
Jeff Kasoff\, RAC\, is the Director of Quality at Byrne Medical\, a leading manufacturer of endoscopy and colonoscopy devices\, where he oversees the operation of the quality system. In this position\, Jeff is responsible for oversight of the document control system\, including maintenance of regulatory documentation. Prior to this\, Jeff spent 13 years at Life-Tech\, Inc. as the Director of Regulatory Affairs\, where he was responsible for compliance of the corporate quality system. Jeff received his regulatory affairs certification in 1996.
Price List\:
Live \: $245.00
Corporate live \: $495.00
Recorded \: $295.00
Overview\: IEC62304 is a internationally recognized software lifecycle standard. The risk dependent activities and documentation requirements necessary for compliance with this document will be explained.
Questions like\:
How much detail is required in the requirement specification?
What is a software unit?
How can integration testing be performed without test harnesses?
will be answered. Practical guidance on how to employ a streamlined but yet compliant development process will be given.
Why should you attend\: This webinar will explain basic design control concepts and the criticality dependent requirements for software development. Software specification\, architectures and resulting design documentation will be discussed\, as well as practical tips on how to streamline the development process and minimize the regulatory burden.
Areas Covered in the Session\:
Software requirements specification
How to write meaningful requirements
Software architectures
Multi software system implementation
Software design documentation
Requirements traceability
Software unit and integration testing
Software testing in real-time systems
Software tools
SOUP (software of unknown providence)
Who Will Benefit\:
Project Management
Regulatory / Quality Control
Software Engineering
Markus Weber\, Principal Consultant with System Safety\, Inc.\, specializes in safety engineering and risk management for critical medical devices. He graduated from Ruhr University in Bochum\, Germany with a MS in Electrical Engineering. Before founding System Safety\, Inc.\, he was a software safety engineer for the German approval agency\, TUV. Since 1991\, Mr. Weber has been a leading consultant to the medical device industry on safety and regulatory compliance issues\, specifically for active and software-controlled devices. In conjunction with the FDA\, he has published works on risk management issues and software-related risk mitigations. Mr. Weber has helped multiple companies\, from startups to Fortune 500 firms.
END:VEVENT BEGIN:VEVENT DTSTAMP;VALUE=DATE-TIME:20130521T192400Z DTSTART;VALUE=DATE-TIME:20120719T160000Z DTEND;VALUE=DATE-TIME:20120719T190000Z UID:http://www.webinarcentral.net/content/osha-national-emphasis-program-nep-anhydrous-ammonia-refrigeration-specific-review URL;VALUE=URI:http://www.webinarcentral.net/content/osha-national-emphasis-program-nep-anhydrous-ammonia-refrigeration-specific-review SUMMARY:OSHA National Emphasis Program (NEP) - Anhydrous Ammonia Refrigeration Specific Review DESCRIPTION:This 3-hr virtual seminar will help you understand the requirements of OSHA PSM and NEP audit topics that have been interpreted and reviewed in the compliance guidelines as they might apply to an anhydrous ammonia refrigeration plant.
Why Should You Attend\:
Effective November 2011 Federal OSHA has embarked on a new National Emphasis Program (NEP). The NEP is focusing on Process Safety Management (PSM) covered chemical plant operations specifically including anhydrous ammonia refrigeration facilities. OSHA has a considerable body of written interpretations and compliance guidelines focused on assisting employers in understanding the NEP as well as PSM (29 CFR1910.119) requirements.
This 3-hr virtual seminar will examine the basics of implementing Federal OSHA PSM requirements in anhydrous ammonia refrigeration facilities. The session will also survey priority audit topics of OSHA National Emphasis Program (NEP) audits. Key topics include review of OSHA formal letters of interpretation and how they affect owners and operators of covered anhydrous ammonia refrigeration processes. The course will also specifically examine the current OSHA PSM compliance directive (CPL-02-02-045) as well as the recent OSHA covered process National Emphasis Program (NEP) compliance directive (CPL-03-00-014).
END:VEVENT BEGIN:VEVENT DTSTAMP;VALUE=DATE-TIME:20130521T192400Z DTSTART;VALUE=DATE-TIME:20120719T160000Z DTEND;VALUE=DATE-TIME:20120719T173000Z UID:http://www.webinarcentral.net/content/cleanroom-management-%E2%80%93-microbial-perspective URL;VALUE=URI:http://www.webinarcentral.net/content/cleanroom-management-%E2%80%93-microbial-perspective SUMMARY:Cleanroom Management – From a Microbial Perspective DESCRIPTION:Description
Why Should You Attend\:
Consequences of not adequately managing cleanrooms are many\, however the most critical is causing harm to the patient.
This session will start with a discussion on designing the cleanroom per product requirements. Additionally\, you will understand the risk posed by inappropriate flows which can affect cleanroom environment. You will learn how to qualify the cleanroom by objectively evaluating the functioning capabilities of the HVAC system to meet pre-determined criteria - classification of cleanroom\, acceptable levels of total particulate counts\, viable particulate count\, air flow rates\, difference pressure\, temperature\, and humidity.
The presenter will provide a scientific risk based approach to cleanroom management as a sure way to ensure production of contamination free products that are safe for human use.
Learning Objectives\:
The objective of this session is to create an awareness about cleanroom management among those who work in cleanrooms so that the productivity can be increased by reducing contamination.
Areas Covered in the Seminar\:
Discussion on facility design as the first step.
Cleanroom qualification – the measure for cleanrooms's capabilities.
Material and personnel flows – points to consider.
Overview\: Regulatory compliance requirements for CFR 21 Part 11/Annex 11 (also known as ERES) have undergone several revisions since its inception during the late 1990s. While the agencies have endeared themselves to the industry by adopting a flexible audit approach for ERES\, they are increasingly requiring companies to comply with the regulations.
Increased number of citations and the recently announced \\"tag along\\" audit approach is a gentle reminder of things to come by way of stricter enforcement of Part 11/Annex 11. It is critical that the industry becomes familiar with the intricacies of the regulation so as to ensure that audits of their systems in this area are citation free.
Why should you attend\: It has been close to a decade since the US FDA published their Scope and Application guidance for CFR 21 Part 11. Since then\, there have been numerous meetings between industry experts and FDA. These meeting addressed issues stemming from implementing the Part 11 regulations. In 2010 the FDA undertook a review of the inspection status of Part 11. The returned to the industry to reaffirm their audit approach to ensure that their Scope and Application guidance of 2003 will remain in effect and that their auditors would continue to audit for and enforce Part 11 in certain specific areas. Such audits would be known as \\"tag along audits\\" with specific audit focus on certain very critical aspects of good electronic documentation to ensure the authenticity and integrity of their data.
Such audits are already in progress and a significant number of citations have been issued in the past 6 months. Attend the webinar to familiarize yourself with this new audit approach for Part 11 and thereby increase your chances for a successful audit. The webinar has been designed to address the subtleties of Part 11 regulations with reference to the items that regulatory agencies are focusing on during their \\"tag along audit\\" strategy. Specifically\, the 483s and Warning Letters pertaining to such audits will be examined for trends and strategies that your company should adopt will be discussed.
Areas Covered in the Session\:
Predicate rules and Part 11/Annex 11 requirements overview
Dependencies between Predicate rules and Part 11/Annex 11
Similarities and differences between Part 11 and Annex 11
Part 11/Annex 11 related SOPs
GDP related 483s and Warning letters
Who Will Benefit\:
Project Managers
Lead Engineers
Software Engineers
Documentation Managers
Document System Control Personnel
Contractor
Consultants
QA
Regulatory Affairs
R&\;D
Manufacturing
Engineering &\; IT personnel
Chinmoy is a seasoned Life Sciences professional. His expertise includes the design\, delivery and validation of industry compliant computerized and control systems for pharmaceutical and biotech manufacturing. His focus is on finding lean integrated manufacturing solutions to include Quality by Design (QbD) and Quality Risk Management (QRM).
He has more than 35 years of hands on industry experience in directing the implementation\, validation and obtaining “fit for use” certification of large biopharmaceutical manufacturing automation and IT systems. These systems conform to regulatory requirements such as CFR 21 Part 11 and Annex 11. He has a very broad experience in facilitating QRM sessions for large US companies and has provided them with consultant oversight to establish their Quality Risk Management plans.
His training sessions are unique in that he combines his field experience to explain the intricacies of applying the regulations. Such an approach of blending theory with practical applications has provided his trainees the necessary skills to lead regulatory efforts in their respective organizations
Price List\:
Live \: $245.00
Corporate live \: $495.00
Recorded \: $295.00
Why Should You Attend\:
Reusable medical devices are receiving more and more scrutiny from regulatory agencies both in the United States and internationally. Sometimes it seems that the requirements for an acceptable cleaning validation are changing on a daily basis. Knowing the latest expectations is critical for a manufacturer so that they can reduce the likelihood that their submission will not be accepted and require additional testing or worst case that it will need to be repeated.
This presentation will address the most current expectations for cleaning validations of reusable medical devices that are performed in support of the instructions in the instruction for use (IFU). It will include both manual and automated cleaning processes as well information on how to choose test soils\, markers for challenging cleaning and the acceptance criteria to use to establish effective cleaning.
Areas Covered in the Seminar\:
* Cleaning validation design - automated cleaning.
* Cleaning validation design - manual cleaning.
* IFU information to be supported.
* Choosing test soils.
* Choosing markers.
* Expectations for controls.
* Acceptance criteria selection.
* Report preparation.
Can you really find new clients in July and August - while still having time to enjoy the summer? You bet!
Discover how to network in unusual places\, make the most of chance encounters\, and make a bigger impact with a lot less work! Leverage the summer slow-down to get a leg up in winning the marketing game - and have more clients come September.
END:VEVENT BEGIN:VEVENT DTSTAMP;VALUE=DATE-TIME:20130521T192400Z DTSTART;VALUE=DATE-TIME:20120720T180000Z DTEND;VALUE=DATE-TIME:20120720T190000Z UID:http://www.webinarcentral.net/content/generate-revenue-webinars-discover-new-way-earn-profit URL;VALUE=URI:http://www.webinarcentral.net/content/generate-revenue-webinars-discover-new-way-earn-profit SUMMARY:Generate Revenue with Webinars\, Discover a New Way to Earn Profit DESCRIPTION:Whether you are looking to earn non-dues revenue or create an additional income source\, offering paid webinars is an easy way to profit from your knowledge. This webinar explores ways to convert your valuable\, industry-specific knowledge into something tangible – and profit from it.
What You Will Learn\:
• Various types of revenue generating webinars
• Tips to create value from content
• Marketing techniques to attract audiences
• Components required to offer CEU credits
Who Should Attend\:
• Professionals who wish to leverage their industry knowledge for profit
• Association Executives who are looking to earn non-dues revenue
• Anyone who has content that is valuable to others
All Attendees will receive\: a copy of \\"Costs of Putting Together a Webinar”
Join us for this free webinar. If you're not able to make it to the webinar\, register anyway! We'll share a recording after the event.
END:VEVENT BEGIN:VEVENT DTSTAMP;VALUE=DATE-TIME:20130521T192400Z DTSTART;VALUE=DATE-TIME:20120720T160000Z DTEND;VALUE=DATE-TIME:20120720T170000Z UID:http://www.webinarcentral.net/content/hplc-outside-box-how-think-chromatographer-webinar-complianceonline-0 URL;VALUE=URI:http://www.webinarcentral.net/content/hplc-outside-box-how-think-chromatographer-webinar-complianceonline-0 SUMMARY:HPLC Outside the Box\: How to Think Like a Chromatographer - Webinar By ComplianceOnline DESCRIPTION:This webinar will identify some of the incorrect lore attached to liquid chromatography and will consider HPLC from a multi-dimensional point of view. It will expand your awareness of fundamental chromatographic phenomena rarely discussed in academic courses so that more informed\, efficient\, and effective choices can be incorporated into the development effort.
Why Should You Attend\:
In the dog-eat-dog world of pharmaceutical development\, time is the factor of greatest concern to management. The temptation to rush through development without fully understanding chromatographic phenomena frequently leads to the validation of methods incapable of quantitation\, specificity\, or even correct identification. This webinar will point out some of the errors in understanding and judgment that lead to such catastrophes\, and will provide sound bases for the evaluation of method suitability. With a solid understanding of the fundamental principles outlined in the presentation\, participants will be able to meet even the most demanding expectations for development timeline without sacrificing method requirements or quality.
The information in this presentation will allow you to understand chromatography as you never have before. Because of the nature of pharmaceutical work\, the knowledge offered in this course may prove critical to the success of development efforts. Chromatographers who employ these ideas will become more efficient and will be less likely to commit some of the errors that are common to our industry\, allowing themselves and their companies to excel.
Learning Objectives\:
The objective of the course is to expand participants’ awareness of fundamental chromatographic phenomena rarely discussed in academic courses so that more informed\, efficient\, and effective choices can be incorporated into the development effort.
END:VEVENT BEGIN:VEVENT DTSTAMP;VALUE=DATE-TIME:20130521T192400Z DTSTART;VALUE=DATE-TIME:20120720T162000Z DTEND;VALUE=DATE-TIME:20120720T173000Z UID:http://www.webinarcentral.net/content/changes-good-pharmacovigilance-practices-eu-webinar-complianceonline URL;VALUE=URI:http://www.webinarcentral.net/content/changes-good-pharmacovigilance-practices-eu-webinar-complianceonline SUMMARY:Changes to Good Pharmacovigilance Practices in the EU - Webinar By ComplianceOnline DESCRIPTION:This 90-minute webinar will provide you a thorough understanding of the updated framework surrounding Good Pharamcovigilance Practices (GVP) in the EU. This will include updates to the EU regulation\, Directive and the first seven PV Modules\, which have been published for consultation.
Why Should You Attend\:
This webinar is focused on understanding the new requirements for Good Pharmacovigilance Practices that will begin to become effective in the European Union beginning July 2012.
The New Guidance on Good Pharmacovigilance Practices (GVP) has been updated by Module\, of which the first seven Modules have been disclosed for public consultation. This course will describe the Regulatory Updates\, Guidance Updates and thoughts on how some Member States’ Competent Authorities will proceed with implementation. These regulatory changes will also impact the EU Clinical Trial Directive and expectations of sponsors in the protection of patients and public health\, before\, during and after a clinical study.
Key Topics to be Discussed\:
- Pharmacovigilance systems
- Reporting and Management of Adverse Reactions
- Periodic Safety Update Reports
- Post Authorization Safety Studies
- Changes to Definitions
- The Pharmacovigilance Risk Assessment Committee
Cloud Computing has been a hot topic and the word \\"Cloud Computing\\" has been used lot more often\, but what is \\"Cloud Computing\\" and why you should learn more about it? To know more about Cloud Computing and to explore the challenges and opportunities that it presents\, take a few minutes to attend this webinar.
END:VEVENT BEGIN:VEVENT DTSTAMP;VALUE=DATE-TIME:20130521T192400Z DTSTART;VALUE=DATE-TIME:20120724T180000Z DTEND;VALUE=DATE-TIME:20120724T190000Z UID:http://www.webinarcentral.net/content/auditing-active-pharmaceutical-ingredient-api-contract-manufacturing-organization-cmo-webin-0 URL;VALUE=URI:http://www.webinarcentral.net/content/auditing-active-pharmaceutical-ingredient-api-contract-manufacturing-organization-cmo-webin-0 SUMMARY:Auditing an Active Pharmaceutical Ingredient (API) Contract Manufacturing Organization (CMO - Webinar By GlobalCompliancePanel DESCRIPTION:Overview\: Auditing an API CMO or any API supplier is a specialty that requires knowledge and experience that is gained through exposure to the unique attributes associated with API manufacturing.
API manufacturing has similar regulatory GMP expectations as drug products\, but not identical in is specific requirements and application. The nature of API manufacturing and its usual purification processes all influence how an API process should operate. Knowing what the FDA expects and how these regulators apply API GMP is important to API purchasers and drug product firms. Reducing risk and protecting the quality of a Drug Product (DP) is critical to the DP firm's success. The webinar will focus on the Q7 and FDA GMP requirements\, what are the key contractual requirements and what should be negotiated and documented within quality agreements with a CMO firm.
Why Should You Attend\: Attending this webinar will help you identify what you need to know and examine during an audit of your CMO or API suppliers. The webinar leader will help you identify key regulatory and industrial issues associated with API manufacturing. You are purchasing more than a chemical or biological material. You are purchasing a material that can carry with it hidden risks if not properly examined and controlled. Such examination is not always productive if you rely simply on testing protocols. You need to learn where to look and what to focus on during any on-site audit. While understanding the applicable GMP is important\, how to apply the GMP and what to establish with a CMO is critical to your supply chain.
Areas Covered in the Session\:
Examine key elements of an API audit
Audit preparation
The audit itself
Opening Session
Audit itself
What to look for?
Discussion of findings
Suggestions and experience
Closing Meeting
Who should participate in audit
Who should attend openning and closing sessions
Audit Reports
Follow-up Actions
Agreed upon Schedules
Follow-up Audits
Who Will Benefit\:
Supervisors and Managers in Manufacturing
Supervisors and Managers in Quality
Engineering
Maintenance Supervisors and Managers
Warehousing and Materials Management Supervisors and Managers
Max Lazar retired from Hoffmann-La Roche Inc. in 2001 after 35 years\, where he was Vice President\, FDA &\; DEA Compliance. In that position he was responsible for compliance oversight of all of the Roche USA businesses including Active Pharmaceutical Ingredients\, Pharmaceuticals (Solid\, Liquid\, and Sterile)\, R&\;D\, Diagnostics\, Fine Chemicals and Vitamins. Following his retirement\, he established a consulting business specializing in API GMP issues and the training of personnel covering the ICH Q7A Guidance as well as the Excipient GMP (IPEC) Guidance. As a voting member of the ICH Expert Work Group (EWG) that developed and negotiated this new international standard\, Max is uniquely qualified to share and explain the EWG’s intent of this new guidance. His involvement in this new API GMP pre-dates the ICH activity itself.
END:VEVENT BEGIN:VEVENT DTSTAMP;VALUE=DATE-TIME:20130521T192400Z DTSTART;VALUE=DATE-TIME:20120724T180000Z DTEND;VALUE=DATE-TIME:20120724T190000Z UID:http://www.webinarcentral.net/content/avoiding-statistical-pitfalls-during-method-validation-webinar-globalcompliancepanel URL;VALUE=URI:http://www.webinarcentral.net/content/avoiding-statistical-pitfalls-during-method-validation-webinar-globalcompliancepanel SUMMARY:Avoiding Statistical Pitfalls during Method Validation - Webinar By GlobalCompliancePanel DESCRIPTION:Overview\: The ICH guideline on Validation of Analytical Procedures (Q2R1) delineates the guidance and methodology for validation characteristics of an analytical procedure.
Like most guidelines\, the terminology is vague enough to allow for several acceptable approaches and analysis. Appropriate statistical methods should be used and all relevant data collected during validation and formulae used for calculating validation characteristics should be submitted and discussed as appropriate. A statistical approach to validation of analytical methods can minimize the amount of testing while meeting the requirements of the guideline.
Areas Covered in the Session\:
Introduction to ICH Q2R1
Statistical methods used during validation
Accuracy versus Precision
Examples and case studies
Who Will Benefit\:
Anyone responsible for\, or affected by\, FDA regulations on analytical method validation
Management
Research and Development
Regulatory Affairs personnel
Quality assurance/quality control personnel
Auditors and inspectors
Mr. Steven Walfish is the President of Statistical Outsourcing Services\, a consulting company that provides statistical analysis and training to FDA regulated industries. Prior to starting Statistical Outsourcing Services\, Mr. Walfish was the Senior Manager Biostatistics\, Non-clinical at Human Genome Sciences in Rockville MD. Prior to joining HGS\, Mr. Walfish was a Senior Associate at PricewaterhouseCoopers specializing in the pharmaceutical industry. Mr. Walfish was Manager of Non-Clinical Statistics at Chiron Diagnostics. Mr. Walfish brings over 20 years of industrial expertise in the development and application of statistical methods for solving complex business issues including data collection\, analysis and reporting.
Price List\:
Live \: $245.00
Corporate live \: $495.00
Recorded \: $295.00
Description
Why Should You Attend\:
The introduction of new drugs and the ongoing researches on therapies directed at critical molecular targets have caused several difficulties among Medical Oncologists and as well as among Companies and CRO. More than 80% of drugs for all indications entering clinical development do not get marketing approval\, with many failing late in development often in Phase III trials\, because of unexpected safety issues or difficulty determining efficacy\, including confounded outcomes. A critical point is related to the clinical trial conduction within the sites. For the above mentioned reasons\, it is important to know what deviations\, violations and exceptions represent and when they could have an impact on the clinical trial results.
Areas Covered in the Seminar\:
- Traditional statistical design of clinical trials in Oncology (phases of studies\, standard endpoints…)
- Introduction of targeted therapies in the Oncology field and the related different needs (i.e. identification and validation of biomarkers).
- Requirements of the regulatory authorities (FDA\, EMEA) and we will focus on the meaning of the terms deviation\, violation and exception and their impact on the clinical trials conduction and results.
Description
Why Should You Attend\:
This webinar will start off with a discussion on the thermal properties of a formulated product and how stabilizing excipients can affect these (the first step in any well designed and understood process and formulation). Next\, the discussion will turn towards understanding the different types of biologically based products commonly encountered in modern pharmaceutical and diagnostic markets\, and the problems with long term stability. The mechanisms and process of stabilization through targeted stabilizing excipients and lyophilization will be covered in great detail\, in addition to understanding the analytical techniques used to develop and verify a suitable formulation and process.
Finally\, the session will finish with a discussion on formulation and stabilization techniques for cells and viruses\, which pose a very large challenge for the formulation and process development scientist.
Learning Objectives\:
Principles of biomolecule stabilization.
Developing a stable biomolecule formulation through stabilizing excipients.
High throughput screening of potential formulations.
Description
This webinar will show you how to audit your GRC program (governance\, risk and compliance) and how to evaluate its design and operating effectiveness.
Why Should You Attend\:
More than ever\, the business community perceives the need not only to articulate the principles of good governance\, compliance\, risk management\, and ethics — but also to integrate these concepts into the fabric of day-to-day business — and use them to drive better performance.
An effective internal audit function is a valuable resource for management\, the board and audit committee due to its understanding of the organization and its culture\, operations\, and risk profile. The objectivity\, skills\, and knowledge of competent internal auditors can contribute to the effectiveness of an organization's internal control\, risk management\, and other governance processes. An internal audit of a GRC program will assist in improving the governance practices of your organization.
Areas Covered in the Seminar\:
Why Should You Attend\:
Change in control agreements between companies and executives\, so-called “golden parachute agreements\,” have become a ubiquitous part of the executive compensation scene for both public and privately held companies. However\, tax code and federal securities law requirements\, investor and media scrutiny\, and potentially high stakes litigation make the development and implementation of golden parachute plans and agreements one of the most important parts of the compensation process.
This session will show how careful drafting and tax planning of golden parachute plans and agreements can help avoid undue scrutiny and criticism\, that will benefit both the company and the covered executive. At the end of this training\, participants will have gained the knowledge and understanding necessary to develop and implement golden parachute agreements and provisions that are more acceptable to the Government\, investors\, buyers\, the media and others.
Areas Covered in the Seminar\:
- Code Sec. 280G and Code Sec. 4999.
- Compensation Paid as a Result of a Change in Control.
- Calculating the Excess Parachute Payment Amount.
- The Exception for S Corporations and Small-Business Corporations.
- Design Features and Typical Provisions.
- Code Sec. 409A.
Presented by Technology focused entrepreneur Boris Glants
Wednesday\, July 25\, 2012 - 01\:00 PM - 02\:00 PM PST
For Registration\: http\://www.corp-corp.com/blog/product-manager-mobile-apps-innovation/?ai...
With the Advent of technology we have the updated info about the world at the finger tips\, at anytime any cast. This interesting webinar “What every product manager developing mobile apps should know - a deep down into product innovation “surely a wonderful place to gather knowledge and share your ideas from and to the world.
Speakers Bio\:
Boris is a seasoned technology focused entrepreneur. Over the past ten years\, he has built multiple companies focused on web and mobile products. Currently he is the CTO of Tonic Solutions where he built the iPad platform for patient data collection that replaces the regular pen and paper used today. It’s being adopted by UCSF\, UCLA\, Duke and other major hospital systems in the US. He is also a technical adviser to www.60minutestrategicplan.com
Essence of our Webinar\:
Understanding when you need to innovate.
What drives innovation\: business demands or technology?
When to apply incremental or leap-frog innovation to your products?
How to systematically apply innovation to product development?
How to manage the innovation life-cycle?
Real-life examples of how innovation was achieved.
There will be a chance for you to share your thoughts and clear your doubts in Query session at the end of the webinar.
We hope that the webinar will be beneficial for you. Please feel free to share this nice opportunity with your friends and neighbors.
Thanks in advance.
END:VEVENT BEGIN:VEVENT DTSTAMP;VALUE=DATE-TIME:20130521T192400Z DTSTART;VALUE=DATE-TIME:20120725T160000Z DTEND;VALUE=DATE-TIME:20120725T173000Z UID:http://www.webinarcentral.net/content/respectful-workplace-harassment-prevention-discipline-managers URL;VALUE=URI:http://www.webinarcentral.net/content/respectful-workplace-harassment-prevention-discipline-managers SUMMARY:The Respectful Workplace\: Harassment Prevention & Discipline for Managers DESCRIPTION:Learn as a manager\, how to detect harassment early and manage proactively.
Why Should You Attend\:
Speak ill of no one\, but speak all the good you know of everybody.
Are you concerned about keeping an harassment-free workplace? Are your managers confused about what is and isn’t appropriate for their employees to say and do? Do you have a policy in place that no one read or knows how to follow? Judi Clements can help. This program is designed to help managers and supervisors take the guess work out of workplace harassment. They’ll hear about case studies that will sharpen their skills for early detection and proactive management of harassment incidents. They’ll learn how to partner with Human Resources to protect your organization and its employees from legal landmines.
Areas Covered in the Seminar\:
This FDA Inspection training provides concrete strategies for planning remediation projects.
Why Should You Attend\:
Today's manufacturing and quality environments are highly automated and computerized. Manufacturers facing FDA pre-approval inspections (PAI) as well as those who will be re-inspected following inspectional observations (FDA-483)\, warning letters and other compliance issues can expect FDA to pay increasing attention to automated manufacturing systems and computerized quality systems. If you have outstanding issues know to your quality unit or to FDA\, now is the time to initiate remediation efforts! This presentation provides concrete strategies for planning remediation projects.
Areas Covered in the seminar\:
- Review current FDA inspection of automated manufacturing systems.
- Review current FDA inspection of quality system software\, such as complaints\, CAPA\, etc.
- How do I determine which systems require remediation?
- What are the planning issues for a remediation project?
- Special considerations for multi-site and global systems
- Software validation concerns.
- 21 CFR part 11 (Electronic Records and Electronic Signatures) concerns.
- Remediation project planning guidelines.
Description\:
This webinar will help you understand the key principles of chemical and safety practices within a laboratory environment. It will provide tools to help you build your Chemical Hygiene Plan (CHP) and ensure compliance with OSHA regulations.
Why Should You Attend\:
Chemical handling\, particularly in the lab environment\, requires an assessment and upfront planning to keep workers safe. Additionally\, labs are faced with an ever-expanding list of Federal\, State and local safety regulations. Anyone that is not fully aware of these regulations is in danger of the hefty fines that can come with non-compliance.
Having a well-written Chemical Hygiene Plan will not only satisfy OSHA requirements for labs\, it will provide you with the framework and guidelines necessary to ensure safe work practices are in place and are followed.
Learning Objectives\:
Upon completion\, participants should be able to\:
Overview\: This webinar is intended for executives and managers\, and explains the business fundamentals of regulatory compliance. It explains what does and does not need to be validated. It describes exactly what is required for compliance with 21 CFR Part 11. This webinar details how to assign team members\, increase productivity\, and lower costs.
Areas Covered in the Session\:
What are the fundamentals of regulatory compliance?
Understand what the regulations mean\, not just what they say.
How to avoid 483 and Warning Letters.
Which SOPs and validation documents are required?
Understand the current computer system industry standards for security\, data transfer\, audit trails\, and electronic signatures.
How to lower costs\, though reduction in resources\, and reduction in documentation.
How to increase productivity by promoting efficient validation and use of computer systems.
Who Will Benefit\:
QA
Managers
Executives
David Nettleton\, is an FDA Compliance Specialist for 21 CFR Part 11\, HIPAA\, and Computer System Validation. His latest book is \\"Risk Based Software Validation - Ten easy Steps\\" that relates to the development\, purchase\, installation\, operation and maintenance of computerized systems used in regulated applications. He specializes in performing gap analysis\, remediation plans\, SOP development\, vendor audits\, training\, and project management. He has completed more than 185 mission critical software validation projects.
Price List\:
Live \: $245.00
Corporate live \: $495.00
Recorded \: $295.00
Overview\: The verification and validation of medical software is coming under increased scruinty by the U.S. FDA. This webinar will address the use of the FDA\, GAMP\, 21 CFR Part 11\, \\"Electronic Records\\"/ \\"Electronic Signatures\\"\, and other applicable industry software validation models\, coupled with the ISO 14971 / ICH Q9 Product Risk Management models\, to structure\, run\, and document acceptable software validations.
The FDA and other regulatory agencies have stated that software validation can only be accomplished effectively if \\"risk-based\\". How can this be done in the \\"real world\\". This webinar will address software that is\:
As-Product
In-Product
Process and/or In Production and Test Equipment
The Quality System.
A manufacturer is responsible to identify these requirements and implement them into an effective software V&\;V process.
Why should you attend\: Software has become pervasive in medical devices themselves\, and in the controlling\, running and monitoring of medical product processes\, whether they be in the pharmaceutical\, medical device\, biologics or dietary supplements industries. Software is being developed for medical imaging\, and even though control of computer for individuals having disabilities restricting hand or eye movement / coordination. The U.S. FDA rightly recognizes that virtually all software quality problems occur in the design\, testing and validation phases\, since replication of software is relatively defect-free. Regulatory auditors are more comfortable with delving into software issues. Recent problems in unrelated industries show the dangers of neglecting thorough\, and risk based\, software verification and validation activities. Effective and real world software V&\;V is even more important in today’s resource constrained industrial environment. This discussion will focus on a preferred U.S. FDA documentation \\"model\\" in various applications\, including ERP\, in-device\, as-device\, process/equipment control\, and cGMP data / Part 11 applications.
Areas Covered in the Session\:
Verification or Validation -- FDA Expectations
The Project Validation Plan
An FDA-accepted Documentation \\"Model\\"
Product and Process / Test / Facilities / Equipment Software V&\;V
When and How to Use DQ\, IQ\, OQ\, PQ (or their equivalents)
GAMP / Other Considerations
The FDA's 11 Key V&\;V Documentation Elements
\\"White Box\\" and \\"Black Box\\" Validations
Who Will Benefit\:
Senior management in Drugs\, Devices\, Biologics\, Dietary Supplements
QA / RA
Software development\, programming\, documentation\, testing teams
R&\;D
Engineering
Production
Operations
Consultants\; others tasked with product\, process\, electronic records software V&\;V responsibilities
John E. Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures\, product risk management\, U.S. FDA responses. In addition\, he has successfully designed\, written and run all types of process\, equipment and software qualifications/validations\, which have passed FDA audit or submission scrutiny\, and described in peer-reviewed technical articles\, and workshops\, world wide. John has also managed pilot production\, regulatory affairs\, product development/design control\, 510(k) submissions\, risk management per ISO 14971\, and projects\; with over 28 years of experience in the FDA-regulated medical products industry - working with start-ups to Fortune 100 companies\, including Abbott Laboratories\, Hospira\, Tyco/Mallinckrodt. He is a graduate of UCLA.
Price List\:
Live \: $245.00
Corporate live \: $495.00
Recorded \: $295.00
Why Should You Attend\:
Today's manufacturing and quality environments are highly automated and computerized. Manufacturers facing FDA pre-approval inspections (PAI) as well as those who will be re-inspected following inspectional observations (FDA-483)\, warning letters and other compliance issues can expect FDA to pay increasing attention to automated manufacturing systems and computerized quality systems. If you have outstanding issues know to your quality unit or to FDA\, now is the time to initiate remediation efforts! This presentation provides concrete strategies for planning remediation projects.
Areas Covered in the seminar\:
Review current FDA inspection of automated manufacturing systems.
Review current FDA inspection of quality system software\, such as complaints\, CAPA\, etc.
How do I determine which systems require remediation?
What are the planning issues for a remediation project?
Special considerations for multi-site and global systems
Software validation concerns.
21 CFR part 11 (Electronic Records and Electronic Signatures) concerns.
Remediation project planning guidelines.
This webinar will provide a basic understanding of regulations and statutes that people involved in the clinical research contract negotiation process must be aware of. You will learn how to negotiate for and create federally complaint agreements and thus avoid the risk associated with violations.
Why Should You Attend\:
Payment for work done in the execution of a clinical trial would seem to be a straightforward proposition\, but in the U.S. a multitude of regulations and statutes and their associated risk can turn contract and budget negotiation into a minefield. Such regulations include the Stark Law\, the Anti-kickback Statute\, the False Claims Act and Medicare Secondary Payer Rule. All parties involved in the clinical research contract negotiation process must be well versed in these rules in order to create federally complaint agreements and thus avoid the risk associated with violations.
Violations of these rules in the course of clinical research have resulted in heavy fines and penalties for well known and respected institutions.
Areas Covered in the Seminar\:
* Stark Law and Clinical Research.
* The Anti-kickback Statute (AKS) and its implications.
* The False Claims Act (FCA) and clinical trial billing.
* The Medicare Secondary Payer Rule (MSPR) and its impact on clinical research contracts.
Online advertising has long held the promise of being the most quantifiable of all media. But with the complexity of the online advertising ecosystem\, increasing overlap across channels\, and the technical challenges associated with online ad delivery\, marketers sometimes find it difficult to justify their online ad spend. How do you make smart allocation decisions and prove the value of your digital advertising?
Join comScore’s Industry Advisor\, Jason Patterson\, July 25 at 11am ET\, and explore the media opportunities available to you in today’s evolving digital industry\, and how leading advertisers are making online measurement actionable. You will learn\:
How to leverage current trends in social\, mobile\, video and display advertising for maximum ROI
How the evolution in multi-screen consumer behavior changes is changing your marketing mix
Critical measurement best practices that will help you make the most of your digital ad spend
Speaker\: Jason Patterson\, Industry Advisor\, comScore.com
For nearly 12 years\, Jason has produced research solutions and analytics yielding actionable insights into media usage and consumer trends for a variety of the world’s largest advertisers. . He has worked with an array of data sources\; tapping into existing syndicated resources\, behavioral data and primary research used to answer clients burning questions and enable actionable media plans.
END:VEVENT BEGIN:VEVENT DTSTAMP;VALUE=DATE-TIME:20130521T192400Z DTSTART;VALUE=DATE-TIME:20120726T180000Z DTEND;VALUE=DATE-TIME:20120726T191500Z UID:http://www.webinarcentral.net/content/fdas-new-enforcement-practices-21-cfr-part-11-webinar-globalcompliancepanel URL;VALUE=URI:http://www.webinarcentral.net/content/fdas-new-enforcement-practices-21-cfr-part-11-webinar-globalcompliancepanel SUMMARY:FDA's New Enforcement Practices of 21 CFR Part 11 - Webinar By GlobalCompliancePanel DESCRIPTION:Overview\: Within the next few weeks and months the FDA will continue to conduct a series of Part 11 related inspections. Planned routine inspections will be extended to evaluate the companies' practices to ensure integrity\, authenticity and availability of electronic records\, The program is the long awaited next step for Part 11 and nevertheless it came as a surprise to the industry.
The FDA already has issued many warning letters related to inadequate integrity\, security and availability of electronic records but also related to validation of software and computer systems. There are many questions about the program\, what inspectors are looking at and to further steps. The webinar will have the answers. And using industry proven case studies attendees will learn how to prepare their organization for trouble-free Part 11 related inspections.
Areas Covered in the Session\:
FDA's current inspection and enforcement practices
FDA's new interpretation\: learning from FDA guidance\, and recent FDA conference presentations and discussions
Learning from FDA inspection reports
Part 11 and the new EU Annex 11\: similarity and differences
Strategy for cost-effective implementation of Part 11\: A six step plan
Recommended changes to existing Part 11 programs to reduce costs
Justification and documentation for the FDA and your management
15 Case studies from laboratories\, offices and manufacturing with graphical workflow of records\, step-by-step description\, recommendations for individual Part 11 requirements with justifications and documentation for the FDA and your management.
How to prepare for Part 11 Inspections
Who Will Benefit\:
IT managers and system administrators
QA managers and personnel
Analysts and lab managers
Validation groups
Software developers
Validation professionals
Training departments
Documentation department
Consultants
Ludwig Huber\, Ph.D.\, is Director of Labcompliance and Chief Advisor for global FDA compliance at Agilent Technologies. He is the editor of Labcompliance\, the global on-line resource for validation and compliance issues for laboratories. He is the author of the books \\"Validation and Qualification in Analytical Laboratories\, and \\"Validation of Computerized Analytical and Networked Systems\\"\, Informa Healthcare.
Price List\:
Live \: $245.00
Corporate live \: $495.00
Recorded \: $295.00
Description\:
This 90-minute webinar will review the categories of credit risk incurred when selling to customers inside the U.S. and the additional risks involved when selling overseas. You will also learn about the various tools that are available to manage these risks.
Why Should You Attend\:
This session will compare commercial and standby letters of credit\, standard and silent letter of credit confirmations\, bank and corporate guarantees\, forfaiting\, factoring\, credit insurance\, credit derivatives\, and foreign exchange contracts from the perspective of what risks each one covers.
At the end of this 90-minute presentation\, participants will learn to identify the different categories of export credit risks and the appropriate tools for managing those risks.
Learning Objectives\:
By attending this training\, you will be able to\:
This 90-minute webinar will show how to select the best technology and format combination to develop a compliant immunogenicity binding method\, and provide a check-list that itemizes all the requirements to develop a compliant validation protocol.
Why Should You Attend\:
The principal components of a meaningful immunogenicity program consist of an initial binding screen followed by confirmation and quantitation of the positive samples.
This 90-minute webinar first reviews the technologies and formats currently in use to detect unwanted immunogenicity. These sections will help the scientist to a priori select the appropriate procedures to specifically meet the needs of their product. The second part of the webinar provides a step by step approach to develop a method that will meet the current validation standards regardless of the technology and format that is utilized. Case studies are cited throughout the webinar to demonstrate the impact of the method on immunogenicity results. Finally\, a check-list is supplied to ensure that essential requirements are in place to proceed into validation.
Learning Objectives\:
Learn how to select the best technology and format combination to develop a compliant immunogenicity binding method.
END:VEVENT BEGIN:VEVENT DTSTAMP;VALUE=DATE-TIME:20130521T192400Z DTSTART;VALUE=DATE-TIME:20120726T180000Z DTEND;VALUE=DATE-TIME:20120726T190000Z UID:http://www.webinarcentral.net/content/complaint-handling-and-management-receipt-trending-webinar-globalcompliancepanel URL;VALUE=URI:http://www.webinarcentral.net/content/complaint-handling-and-management-receipt-trending-webinar-globalcompliancepanel SUMMARY:Complaint Handling and Management\: From Receipt to Trending - Webinar By GlobalCompliancePanel DESCRIPTION:Overview\: An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and\, if necessary\, thoroughly investigated and analyzed\, and corrective action shall be taken.
The results of this evaluation should lead to a conclusion regarding whether the complaint was valid\, what the root cause of the complaint was\, and what action is necessary to prevent further occurrences. Complaints cannot be ignored. They are an excellent indicator of problems with the use\, design\, and/or manufacture of a product. A single complaint that is thoroughly investigated may lead a company to take remedial or corrective action. It may also take an ongoing analysis of numerous complaints before a trend is spotted that causes a company to initiate changes in their product\, labeling\, packaging or distribution. The regulatory expectations for both pharmaceuticals and medical devices will be emphasized as well as overview of best practices for timely and effective investigations.
Areas Covered in the Session\:
Understand how and why CAPA is tied in to product complaint investigations
Examples of tools currently being used to conduct investigations
How far and in-depth do you go with your investigations
What are current FDA \\"hot\\" buttons and trends
Benchmarks and best practices for investigations
How to become a \\"good\\" investigator and the emphasis on closed-loop investigations
Why risk-based approaches are vital to the decision-making process
How to improve and bullet-proof your product complaint management system with investigations
Who will benefit\:
This webinar will provide valuable assistance and guidance to the life sciences manufacturers engaged in various aspects of product complaint investigations. The employees who will benefit include\:
All levels of Management for all departments and those who desire a better understanding
QA/QC/Compliance/Regulatory Affairs
Marketing &\; Sales &\; Customer Service
Engineering/Technical Services
Consultants
Operations and Manufacturing
David R. Dills\, an independent Regulatory &\; Compliance Consultant with more than 22 years of hands-on experience and a proven track record within the FDA regulated industry\, has an extensive regulatory and compliance background with Class I/II/III and IVD devices and managing and handling activities within the global regulatory and compliance landscape. He manages quality\, regulatory and compliance projects with multiple competing priorities having a direct impact on site operations and commercial opportunities and develops strategies for governmental approval to introduce new products to market\, provides guidance and direction on regulatory and compliance requirements and prepares/reviews worldwide submissions/dossiers/technical files and addresses requirements in the EU\, Pacific Rim and The Americas regarding all aspects of device commercialization and especially FDA activities. Background encompasses broad capabilities in quality systems\, validation\, regulatory affairs\, GxP compliance\, auditing\, interfacing with the regulatory agencies\, managing enforcement actions and mitigating compliance exposure for companies\, working with Notified Bodies\, AR’s and demonstrates credible experience to maximize business performance in the devices arena. He strives to optimize business performance through proactive strategies to mitigate compliance exposure by providing strategic and tactical solutions that facilitate the achievement of regulatory milestones. David has been previously affiliated with well-known device manufacturers and service providers\, including a well-known CRO and has served in various quality\, regulatory and compliance management and advisory capacities with increasing responsibilities. David is an accomplished industry speaker and author of technical and compliance related topics published in industry journals. Please refer to his profile provided herein for additional information about his background.
END:VEVENT BEGIN:VEVENT DTSTAMP;VALUE=DATE-TIME:20130521T192400Z DTSTART;VALUE=DATE-TIME:20120726T180000Z DTEND;VALUE=DATE-TIME:20120726T180000Z UID:http://www.webinarcentral.net/content/bullet-proof-capa-webinar-globalcompliancepanel URL;VALUE=URI:http://www.webinarcentral.net/content/bullet-proof-capa-webinar-globalcompliancepanel SUMMARY:Bullet-Proof CAPA - Webinar By GlobalCompliancePanel DESCRIPTION:Overview\: This CAPA training program helps you to understand\, in 10 easy steps\, the entire CAPA process. It includes elements of Quality Tools\, Team Effectiveness\, Awards &\; Recognitions\, and Verification &\; Validation of actions taken. Attend this webinar to grasp the A to Z of CAPA and learn how to implement &\; manage it for success.
Why Should You Attend\: We have found out\, through auditing many organizations world-wide that the organizations are pretty good when it comes to corrective actions yet they are not nearly as good when it comes to the preventive actions. This webinar should provide you with enough ideas\, suggestions and HOW TOs that you and your teams and organization overall get much better on the preventive actions and even better on the corrective actions. Includes all elements of CAPA process step as required by ISO and regulatory agencies.
In addition\, it is represented in a practical and proven manner which can be immediately applied in your organization.
Areas Covered in the Seminar\:
Module 1
Introduction and Overview
Correction vs. Corrective Action
Understanding of all elements of CAPA process step as required by ISO and regulatory agencies
Introduction to CAPA elements in a practical and proven manner which can be immediately applied in your organization
Supporting stories and practical examples of CAPA - when each is appropriate and when one or the other is not appropriate
The regulations and international requirements for CAPA and the clear understanding how to suit your procedures\, work instructions and forms to address it
Module 2
Examples of problem solving tools\, management tools and measurement tools\, which are great for identification of the true root cause(s) of the issue
These tools also used for corrective actions\, for most optimal definition of the improvement\, for preventive actions
Visual representation of the tools and examples where and when to use them
Importance of proper assignment of a CAPA
Examples are provided when it might be a good thing to assign a CAPA to a team
Examples when would be a good thing to assign a CAPA to an individual
Examples and definitions of teams and team members roles and responsibilities
It can be used and applied in other areas inside and/or outside the organization when and where team work is required and expected
This section by itself can be taken out and applied to other processes and practices within or outside of the organization with the goal of continuous improvement
Module 3
Emphasize the importance and need of completing the verifications and/or validations of the actions taken to ensure that the issue has been resolved and the true root cause of the issue has been removed
Real-life examples and suggestions which can be used immediately after completing the webinar
Module 4
Examples how to appropriately award and recognize teams and individuals for producing the results
Additional references and pointers where more successful examples and instructions can be found so that you and your organization can benefit and profit more from the CAPA process and CAPA teams - and maybe more importantly have those outside the quality department more engaged and interested in participating in CAPA and continuous improvements
Q &\; A
Who Will Benefit\:
Quality Managers
Quality Engineers
Small business owners
CAPA investigators
Inspectors
Six Sigma specialists
Consultants
Jasmin NUHIC serves a major medical devices OEM as a Sr. Compliance Quality Engineer and 21 CFR Part 11 Subject Matter Expert. He also served ASQ section as a chair for two consecutive terms\, has taught quality certification exam prep course\, completed numerous software validations and obtained over 25 different certifications in leadership\, quality\, software validations\, and more. Jasmin NUHIC has conducted Webinars on this and other topics with high attendance and appreciation.
END:VEVENT BEGIN:VEVENT DTSTAMP;VALUE=DATE-TIME:20130521T192400Z DTSTART;VALUE=DATE-TIME:20120726T160000Z DTEND;VALUE=DATE-TIME:20120726T170000Z UID:http://www.webinarcentral.net/content/making-sense-fda%E2%80%99s-proposed-rules-development-and-approval-biosimilars URL;VALUE=URI:http://www.webinarcentral.net/content/making-sense-fda%E2%80%99s-proposed-rules-development-and-approval-biosimilars SUMMARY:Making Sense of FDA’s (proposed) Rules for the Development and Approval of Biosimilars DESCRIPTION:This webinar will help you understand the process\, requirements\, quality and safety considerations for demonstrating biosimilarity to a Reference Product. You will learn about what type and how much clinical data are needed to support a showing of biosimilarity.
Why Should You Attend\:
On February 9\, 2012\, the U.S. Food and Drug Administration (“FDA” or “Agency”) released three highly anticipated guidance documents designed to answer industry questions regarding the development and approval of biosimilars (a/k/a follow-on biologics). The guidance documents provide specific advice and recommendations on steps applicants can take to obtain approval of a proposed biologic product under FDA’s proposed abbreviated approval pathway.
The Biologics Price Competition and Innovation Act of 2009 (“BPCIA”) amended the Public Health Service Act by adding Section 351(k) which created an abbreviated approval pathway for biological products that are found to be “highly similar” or “interchangeable” with a reference biological product (e.g.\, vaccines\, antibodies\, blood and blood components\, gene therapies\, tissues\, and proteins) that have already been approved or “licensed.”
Areas Covered in the Seminar\:
- FDA's regulation of biosimilars.
- The process and requirements for demonstrating biosimilarity
- The February 2012 FDA Guidance Documents on Biosimilars
- Quality Considerations for demonstrating biosimilarity
- Safety Consideration for demonstrating biosimilarity
- The process of obtaining biosimilar approval
This 90-minute webinar will review the new and proposed HIPAA Privacy and Security regulations and discuss their effects on the use of Electronic Health Records (EHRs).
Why Should You Attend\:
Many of the new changes to HIPAA focus directly on a number of aspects of the use of electronic records\, such as the accounting of disclosures and tracking of accesses of records of all kinds\, even for treatment\, payment\, and healthcare operations\, and the provision of records in electronic formats when requested. These proposed rules have a tremendous impact on not only EHRs\, but also any electronic systems that hold protected health information in the designated record set.
In this 90-minute webinar we will review the new and expected regulations and discuss their effects on the use of EHRs. We will show what policies need to be changed and how\, discuss how disclosures must be tracked in an EHR\, review the various ways patient records can be supplied electronically\, discuss the requirements for meeting the mandatory Privacy and Security Objective in the Meaningful Use regulations (including requirements for a HIPAA Security Risk Analysis)\, and show what policies and evidence you need to produce if you are audited by the HHS Office of Civil Rights. The new enforcement penalty structure and the new program for random audits by HHS OCR will also be described.
Agenda\:
This webinar discusses the high risks of scientific misconduct in regulated studies. You will understand the main issues in producing study results of the highest integrity\, learn how managers can implement a system for ensuring accurate and reliable data\, understand the \\"red flags\\" of questionable data or reporting and develop a plan for identifying the high-risk steps in your operation.
Why Should You Attend\:
This presentation discusses the high risks of scientific misconduct in regulated studies. It distinguishes between large and small errors in misjudgment and how QA professionals manage these occurrences. It also describes a plan for ensuring the highest ethical standards in your lab. The webinar begins by giving a brief introduction to terms related to regulatory action\, such as “fraud\,” “misconduct\,” “injunction\,”\, “disqualification\,” etc. It describes the root causes of scientific misconduct. These root causes are discussed with special attention to the various individuals most likely to make these errors in judgment. Thus\, the webinar covers ethical behavior with respect to sponsors\, testing facility management\, study directors\, study scientists\, regulatory affairs professionals\, and quality assurance professionals. The webinar then summarizes the main warning signs of scientific misconduct from the perspective of regulatory agencies and auditors. This discussion covers “red flags” in raw data\, reporting\, and the sponsor-CRO relationship.
Areas Covered in the Seminar\:
- How to recognize fraud and scientific misconduct
- Why scientific fraud and misconduct happen
- What are the warning signs of scientific misconduct?
- How QA professionals can spot scientific misconduct
- How to develop a plan for identifying high-risk situations
- How to analyze a case of possible scientific misconduct
- What is the role of QA professionals in scientific integrity
- What are the risks of scientific misconduct?
This 90-minute webinar will show how to select the best technology and format combination to develop a compliant immunogenicity binding method\, and provide a check-list that itemizes all the requirements to develop a compliant validation protocol.
Why Should You Attend\:
The principal components of a meaningful immunogenicity program consist of an initial binding screen followed by confirmation and quantitation of the positive samples.
This 90-minute webinar first reviews the technologies and formats currently in use to detect unwanted immunogenicity. These sections will help the scientist to a priori select the appropriate procedures to specifically meet the needs of their product. The second part of the webinar provides a step by step approach to develop a method that will meet the current validation standards regardless of the technology and format that is utilized. Case studies are cited throughout the webinar to demonstrate the impact of the method on immunogenicity results. Finally\, a check-list is supplied to ensure that essential requirements are in place to proceed into validation.
Areas Covered in the Seminar\:
Many marketers have differing opinions on marketing strategy. When is the right time to employ outbound tactics vs. inbound? When does a content strategy make sense vs. product focused messaging? There are marketers who regularly purchase marketing lists to amp up their program performance and others who choose not to. If you decide to utilize a targeted list\, what's next? You need to be able to capitalize on this list and maximize the ROI.
So how is a marketer to know what is right for them? In this live\, interactive event\, Net Prospex VP of Marketing Maribeth Ross will provide food for thought on deciding the right time to use a marketing list. LeadFormix's Enablement Manager\, Mike Sasaki\, will show you how you can get the most from a list using marketing automation basics to boost the number of qualified leads passed on to your sales team.
We'll discuss\:
• The right and wrong time to utilize targeted lists
• How to calculate how many new prospects you need at the top of the funnel to meet revenue goals
• What to look for when buying new data
• How to identify sales-ready buyers - How to qualify leads from a list
Date &\; Time-
Thursday\, July 26\, 2012 at 11.00 AM PDT.
About LeadFormix
LeadFormix is owned and backed by CallidusCloud (NASDAQ\:CALD)\, a leader in cloud based Sales Effectiveness and Marketing Automation suite. Built by Marketing\, Made for Sales is our mantra. Our customers have described LeadFormix in various ways such as \\"the Ferrari of Marketing Automation\\"\, \\"an all-in-one digital marketing solution\\"\, \\"the marketing automation solution with the fastest ROI\\"\, and \\"the only marketing automation solution loved by sales teams\\".
Course Description\:
Understanding GLP regulations and requirement and achieving GLP compliance can significantly expedite the regulatory processes\, bringing innovative medical products to the market faster and saving enormous amount of your unnecessary time\, efforts and investment.
During this interactive workshop\, Dr. David Lim (Regulatory Doctor) will walk you through the relevant and applicable US regulations\, regulatory requirements and guidance necessary for good laboratory practice (GLP) and GLP compliance. This workshop is intended to provide guidance on GLPs for conducting nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for pharmaceutical and medical device products for human use regulated by the United States Food and Drug Administration (US FDA). During this workshop (2nd day)\, group discussions on implementing GLPs will be engaged.
Areas Covered\:
The following areas will be discussed during this workshop\:
* US FDA GLP regulations and requirements
* Good laboratory practices\: scope\, objectives and definitions
* Organization and personnel\: personnel\, management\, study director and quality assurance unit
* Facilities and equipment
* Testing facilities operation\: standard operating procedures (SOPs)
In this interactive Webinar\, you will learn various tactics that can be used to significantly increase your online presence and build new business.
How to use PPC Pay Per Click advertising
How to develop a key phrase list
How to develop paid search adverts
What is SEO ( Search Engine Optimization ) and what do I need to know about it?
How to develop landing pages to generate leads
How to track results
You'll learn how to get in front of people who are actively seeking your products and services
Hosts\:
HostJeff Werlwas
Jeff Werlwas is the Senior Product Manager for Search Engine Optimization (SEO) and Search Engine Marketing (SEM) solutions for Deluxe Corporation. Since 2004\, Jeff has helped hundreds of small businesses increase their internet visibility. In this webinar Jeff will show you inexpensive techniques to help you increase your internet presence.
HostAndrew Patricio
BizLaunch was founded in 2003 by Andrew Patricio who has over 25 years of entrepreneurial experience. During this time he has started seven businesses\, and has authored two books on small business topics. As an internationally recognized small business expert\, Andrew has traveled throughout Canada\, Russia\, Latvia\, Italy\, Portugal\, Sweden\, Korea\, USA\, Holland\, Namibia\, Belgium\, USA\, Barbados and South Africa to train small business owners.
Description\:
This webinar will cover the OSHA compliant policies\, procedures and protocols you must have in place to perform a thorough\, objective and professional investigation in the event of an accident or the near miss of an accident in the workplace.
Why Should You Attend\:
In the event of an accident or the near miss of an accident in the workplace\, employers are required to perform a thorough\, objective\, professional investigation. The investigation’s purpose is to discover the reasons for the accident or near miss occurrence\, and then rectify the situation so a further accident is avoidable or becomes less likely.
The presence of solid safety investigation protocols also lessens the probably of an accident occurring as unsafe conditions can be discovered before an accident can occur.
END:VEVENT BEGIN:VEVENT DTSTAMP;VALUE=DATE-TIME:20130521T192400Z DTSTART;VALUE=DATE-TIME:20120731T160000Z DTEND;VALUE=DATE-TIME:20120731T170000Z UID:http://www.webinarcentral.net/content/procure-pay-p2p-metrics-and-dashboards-webinar-complianceonline URL;VALUE=URI:http://www.webinarcentral.net/content/procure-pay-p2p-metrics-and-dashboards-webinar-complianceonline SUMMARY:Procure to Pay (P2P) Metrics and Dashboards - Webinar By ComplianceOnline DESCRIPTION:Description\:
This session will provide a roadmap for the implementation of key metrics that can be used in formulating a P2P Dashboard. Attendees will learn how to actually use metrics and trends to develop areas for business process improvement.
Why Should You Attend\:
The P2P process can be difficult to measure since procurement and accounts payable may report to different organizations. In some companies\, accounts payable usually reports through finance and procurement may report to supply chain management.
This session will identify the key functions that impact the P2P process. The instructor will focus on the integral dependencies within the P2P process. We’ll discuss how metrics can highlight the negative and positive aspects of this important process. We’ll discuss how the P2P process can provide cost savings and improvements to working capability. The instructor will also provide examples of metrics and dashboards that have been used at well known companies.
Who Will Benefit\:
Description\:
This webinar will provide a comprehensive overview of the Clinical and Laboratory Standards Institute (CLSI) Laboratory Quality Control Based on Risk Management\; Approved Guideline\, EP-23-A\, produced in partnership with the Clinical Laboratory Improvement Amendment (CLIA).
Why Should You Attend\:
Anyone overseeing Quality Control for a CLIA licensed laboratory should learn about the new QC option being implemented this year based on this collaboration between CLIA and CLSI. The document reviewed here provides a road map for “developing and maintaining a quality control plan (QCP)”\, founded on the principles of risk management.
This presentation examines QC methods for collecting the essential data needed to conduct a risk assessment and\, thus identify areas in processes that may reduce risk. These risk monitors are potentially failure points that may be reduced or eliminated. These QC measures are part of the Quality Management System’s Quality System Essential (QSE)\, Process Management\, to continually improve your laboratory’s testing outcomes.
END:VEVENT BEGIN:VEVENT DTSTAMP;VALUE=DATE-TIME:20130521T192400Z DTSTART;VALUE=DATE-TIME:20120731T160000Z DTEND;VALUE=DATE-TIME:20120731T170000Z UID:http://www.webinarcentral.net/content/maximizing-roi-each-compliance-effort-webinar-complianceonline URL;VALUE=URI:http://www.webinarcentral.net/content/maximizing-roi-each-compliance-effort-webinar-complianceonline SUMMARY:Maximizing ROI on Each Compliance Effort - Webinar By ComplianceOnline DESCRIPTION:Description\:
This webinar will show how to augment compliance efforts and testing with a performance based initiative. The training will discuss performance based compliance initiatives including HR compliance\, onboarding and downsizing.
Why Should You Attend\:
This session will provide participants with a greater understanding of the importance of human capital in building a sustainable and compliant organization\, while achieving the necessary returns on invested capital and maximizing business value. This webinar includes but is not limited to showing participants how to improve compliance\, establish performance-based ethics compliance\, and improve safety compliance\, risk management and corporate governance. Other performance based compliance initiatives will also be discussed including HR compliance\, onboarding and downsizing.
Areas Covered in the Seminar\:
This 90-minute webinar will cover the best industry practices for Failure Modes and Effects Analysis (FMEA). You will learn what mistakes to avoid\, how to reduce design and manufacturing defects\, and how to implement risk management efficiently.
Why Should You Attend\:
FMEA is one of the most important tools for risk management according to the ISO 14971 standard because it identifies known and unknown risks very early when the cost of reducing risks is very low. It can reveal missing requirements\, vague requirements\, missing functions\, and point out component and manufacturing problems well before process validation. These in turn reduce life cycle costs and reduce the time to market. But\, the tool has several inherent traps that should be recognized and avoided.
This 90-minute presentation covers the best industry practices in using Failure Modes and Effects Analysis (FMEA). You will learn about what mistakes to avoid\, how to reduce design and manufacturing defects\, and how to implement risk management efficiently. Several case examples will be presented to give a hands-on feel to attendees.
Learning Objectives\:
At the conclusion of the module\, you will learn\:
* The most efficient method for FMEA.
* How FMEAs are misused in medical device industry.
* How to integrate FMEA into the risk management process.
Overview\: Design History Files (DHF)\, Device Master Records (DMR)\, and Device History Records (DHR) are key building blocks used in the design\, development\, manufacturing\, and cGMP compliance for the Medical Device Industry. Too often\, these are cluttered\, confusing\, and cause many errors due to the way they are created\, organized\, and managed.
This webinar applies the Theory of Lean Documents and also formulates a corresponding Theory of Lean Configuration to these key elements of medical device documents.
Why you should attend\: Do you find yourself constantly struggling to create\, manage\, and maintain all of the information found in DHFs\, DMRs\, and DHRs - which is often redundant\, repetitive\, and chained together in a cumbersome way? Do you find that your design and manufacturing resources are spending way too much time on documentation and not enough on engineering and design? This webinar presents a fresh new approach based upon solid principles and proven practices - as well as an alternative that avoids many of the pitfalls of traditional ways of preparing these documents.
Areas Covered In the Session\:
Brief introduction to Lean Documents and Lean Configuration
Quality System Regulation\, 21 CFR Part 820\, as it applies to DHF\, DMR\, and DHR
Design History Files (DHF) content\, development\, and management
Device Master Records (DMR) content\, development\, and management
Device History Record (DHR) content\, development\, and management
Applying lean principles to creating\, developing\, and managing a DHF
Applying lean principles to creating\, developing\, and managing a DMR
Applying lean principles to creating\, developing\, and managing DHRs
Who will benefit\: Managers\, Supervisors\, Directors\, and Vice-Presidents in the areas of\:
R&\;D
Manufacturing Engineering
Quality Assurance
Operations
Document Control
José Mora is a Principal Consultant specializing in Manufacturing Engineering and Quality Systems. For over 29 years he has worked in the medical device industry specializing in manufacturing\, process development\, tooling\, and quality systems. Prior to working full time as a consulting partner for Atzari Consulting\, José served as Director of Manufacturing Engineering at Boston Scientific and as Quality Systems Manager at Stryker Orthopedics\, where he introduced process performance\, problem solving\, and quality system methodologies. During that time he prepared a white paper on the application of lean manufacturing methods to the creation and management of controlled documents and a template for strategic deployment. José led the launch of manufacturing at a start-up urology products company as Director of Manufacturing for UroSurge\, Inc. at the University of Iowa’s business incubator park in Coralville\, IA\, creating a world-class medical device manufacturing operation\, with JIT\, kanban systems\, visual workplace and lean manufacturing practices. José worked for 10 years at Cordis Corporation\, now a Johnson &\; Johnson company\, where he led the successful tooling\, process development and qualification of Cordis’ first PTA (percutaneous transluminal angioplasty) catheter. His medical device experience includes surgical instruments\, PTA &\; PTCA dilatation and guiding catheters\, plastic surgery implants and tissue expanders\, urology implants and devices for the treatment of incontinence\, delivery systems for brachytherapy\, orthopaedic implants and instruments\, and vascular surgery grafts and textiles. During his time at Cordis\, José managed the Maintenance and Facilities Department\, taking that operation to a level rated as “tops” by the UK Department of Health and Social Services (DHSS) during one of their intensive audits. Jose managed Manufacturing Engineering as part of the Guiding Catheter Core Team of managers\, a team that took the Cordis Guiding Catheter business to lead the market\, bringing it up from fourth place. By introducing world-class techniques\, the Guiding Catheter design and manufacturing was completely re-engineered for robust design and tooling\, under Jose’s leadership. He was also instrumental and played a leadership role in the complete re-engineering of the Tooling Control System\, including design drafting\, the tool shop and technical support. Wherever he has worked\, he has a track record of introducing world-class methodologies such as Kepner-Tregoe\, Taguchi techniques\, Theory of Constraints\, Lean Manufacturing\, Five Ss (Visual Workplace)\, process validation to GHSS standards\, and similar approaches.
Price List\:
Live \: $245.00
Corporate live \: $495.00
Recorded \: $295.00
This 3-hr virtual seminar will cover areas where human resources should be especially vigilant in times of complex labor laws\, changing environments and reorganization of the workforce. We will discuss “hot spots” and specific areas at risk to be sure they are addressed as well as new laws which must be followed\, giving added advice to anticipate future needs and obligations.
Why Should You Attend\:
This session will cover areas where human resources should be especially vigilant in times of complex labor laws\, changing environments and reorganization of the workforce. Responsibility lies heavily on Human Resources professionals to avoid any action or inaction which might present problems or liability for an organization. They must also take proactive measures to assure their organization has equitable and effective management and the correct talent necessary to advance the organization and execute its business plan.
The presentation will concentrate on “hot spots” to be sure they are addressed as well as new laws which must be followed\, giving added advice to anticipate future needs and obligations.
The presenter will detail specific areas at risk and provide preventative actions to eliminate or minimize problems or future liability.
Learning Objective\:
Are you struggling to understand conceptual study and product flow in Oracle Order Management (OM)? You'll find your answers in the Free Webinar\: A Concise View Of Oracle Order Management (OM).
This webinar will provide the conceptual study and product flow in Oracle Order Management (OM). Also you'll be able to understand the primary set up steps\, key features of other modules which we have to define to execute the Order to Cash flow.
Agenda\:
* Introduction of Oracle Order Management
* O to C Lifecycle
* Drop - Shipment and Back to Back Orders
* MOAC Setups
* Key Entities of Inventory and Receivables w.r.t. Order Management (OM)
* Basic Setups For Oracle Order Management (OM)
* Corporate and Career Benefits
* Q &\; A Session
Date\: 31st July 2012\, 7\:00 – 8\:00 PM IST
For free registration\:
https\://www1.gotomeeting.com/register/306297824
Read more\:
http\://www.iwarelogic.com/resources/webinars/concise-view-of-oracle-orde...
Overview\: This webinar will review the different types of master regulatory files necessary for demonstration of compliance with GXP procedures\, providing the regulatory authorities with appropriate data\, and maintaining a well organized source/support documentation.
Each submission to the FDA and any other regulatory entity is carefully prepared to present information from primary and secondary sources. The information in any submission needs to be able to be tracked all the way forward to the market application but also backwards to the raw data and indication that it was collected under GXP procedures. Proper organization and tracking of the regulatory files and their associated source documents can save companies thousands in time during the organization of any submission.
The presentation will include descriptions of organization of the different regulatory communications and submissions\, with appropriate tracking of key regulatory development dates to assure that submission are presented on time. In addition development of a tracking document for support nonclinical studies and GMP documents will be recommended. Compilation of regulatory meeting minutes generated internally and from the regulators will be briefly discussed. The organization of the Trial Master Files will be defined.
Additional descriptions of the 5 types of Drug Master Files and Veterinary Master Files and their utility will be describedQuality assurance audits of regulatory files should be able to trace all data back to the original data and should be able to do so schematically. Document mapping methods will be discussed as useful tools that help assure the regulatory department has the necessary information.
Areas Covered in the Session\:
Regulatory master files
GXP requirements
Regulatory chronology
TMF\, DMF
Organization
Quality audits
Good documentation practices
Who will benefit\: This webinar will provide valuable assistance and procedures for sponsors\, regulatory departments\, consultants project managers\, clinical trial managers\, CROs\, CMOs\, and clinical trial vendors (central labs\, drug supply imaging service companies).
The following individuals would benefit from this webinar\:
Regulatory affairs personnel
Quality assurance/control
Clinical operations
Project managers
Clinical Research Associates (CRA)
Clinical Trial Associates (CTA)
Medical monitors
Pharmacovigilance specialists
Site managers
Contract manufactures
Nutraceutical manufactures
Dr. McLane has over 25 years of progressive experience in all phases of global development with both large and small pharmaceutical companies. His knowledge basis has lead full development projects with over 50 clinical and medical device programs and to successful INDs\, IDEs\, NDAs and EMEA/CTA applications. Key strengths include the early development of clinical and regulatory strategies\, risk management and identification\, and negotiating with regulatory officials.
Additional development activities include developing business rationale\, teams\, programs\, and strategies for early clinical and combination product candidates in metabolic diseases\, respiratory and oncology areas. He has also successfully completed in- and out-licensing reviews and negotiations including those for orphan indications and in vitro diagnostics. He possesses particular expertise in the initial formation and development of new start-ups and early clinical companies and has provided major contributions to business plans and presentations to venture capitalists for significant fund-raising.
Dr. McLane has been leading recent regulatory and clinical services for clients in the various therapeutic areas at Clinquest.
Price List\:
Live \: $245.00
Corporate live \: $495.00
Recorded \: $295.00
Phone\: 800-447-9407
Fax\: 302-288-6884
webinars@globalcompliancepanel.com
http\://www.globalcompliancepanel.com
Overview\: Water system validation is often considered a necessary evil intended to merely satisfy a regulatory expectation. If done using a one-size-fits-all template\, it probably satisfies regulatory requirements but is indeed a waste of time when it could be a valuable \\"insurance policy\\". All water systems are different and have different challenges in consistently purifying and delivering acceptable water to users.
Therefore\, the validation details used for every water system should probably be unique\, making a standard template convenient\, but inappropriate. Using a little common sense and knowledge of how the water system works and is maintained\, the thoughtful validation of a water system can be very worthwhile. This presentation will cover the basic ground rules you should have in place before embarking on water system validation\, how that validation should be customized to your particular water system design and maintenance practices\, what operational elements should be included in the validation based on potential impact\, what happens when the \\"honeymoon\\" is over and the system ages\, and at what point is validation finally over. Because of water system and validation costs\, packaged water options are sometimes considered\, but additional costly issues for packaged waters may not have been considered\, as will be discussed. Also discussed will be lab water systems that may have special validation needs different from production's water systems.
Why Should You Attend\: Are you sure your water system was properly validated? Have you ever had chemical or microbial control problems with the water system that did not show up during validation? Have those problems ever caused manufacturing interruptions? Have those problems ever caused product problems? Are you absolutely sure? Though FDA is often glad to see that any sort of water system validation has been done\, they will quickly raise their expectations (and \\"483 pad\\") if your validation was poorly done and resulted in product/health problems. You can avoid this regulatory attention as well as these product problems by applying a little logic to your validation protocol and avoiding standard templates which may not be the right challenge for YOUR water system. However\, to apply logic\, you MUST understand how your water system is intended to work and what could make it fail to do so. With every water system being different\, a customized validation protocol is a necessity. Attending this presentation will allow you to understand what water system features are essential to include in validation (and which are not)\, and will also explore the validation needs of laboratory water systems as well as issues related to supposedly cost-avoiding options like using package waters.
Areas Covered in the Session\:
Why validate a water system?
Basic ground rules for water systems before you validate them
Micro Test Method “validation”
Minimum validation expectations
How to figure out what you should validate
What happens after the honeymoon is over
Is validation ever really over?
Special considerations for lab water systems
Are packaged waters a viable option?
Who Will Benefit\: This webinar will be valuable for all companies that operate non-compendial deionized water systems as well as WFI or Purified Water systems\, particularly for those in FDA and EMA regulated industries\, including Medical Devices\, Diagnostics\, Pharmaceutical APIs and Dosage Forms\, Biologics\, consumer products\, and cosmetics companies. The specific job functions that will benefit include\:
Validation managers and personnel
QA managers and other personnel involved in Change Control programs
Utility operators and their managers involved in maintaining and sanitizing water systems
QA managers and Regulatory Affairs personnel involved in defending water system operations and quality data to FDA and EMEA inspectors and outside auditors
QA managers and personnel involved in investigations of excursions and preparing CAPAs
QC managers and personnel involved in sampling\, testing\, and trending chem and micro data from water systems
Consultants
T.C. Soli\, is a Ph.D. Microbiologist and President of Soli Pharma Solutions\, Inc. (www.solipharmasol.com)\, and since becoming a full time consultant\, has served consumer products and FDA-regulated industries with training and troubleshooting expertise covering water systems\, sterilization\, aseptic processing\, microbiological and beta-lactam contamination control\, microbiological laboratory operations\, and has served as a pharmaceutical expert witness in several \\"contamination\\" litigations. Prior to full time consulting\, he had 25 years of diverse \\"Big Pharma\\" operating company experience. During his 31+ year career he has lectured extensively at conferences\, authored numerous papers and recently written several book chapters related to water system microbiology for USP\, PDA and ISPE publications. He is currently serving in his third five-year term on USP Expert Committees responsible for Pharmaceutical Waters through which he authored the complete rewrite of USP Chapter <\;1231>\; which many consider to be USP's \\"pharmaceutical water bible\\".
Price List\:
Live \: $245.00
Corporate live \: $495.00
Recorded \: $295.00
Phone\: 800-447-9407
Fax\: 302-288-6884
webinars@globalcompliancepanel.com
http\://www.globalcompliancepanel.com
Overview\: Medical device firms need to be aware of the benefits of compliance as well as the dangers of inadequate complaint handling. This Webinar will explain the regulatory process and in understandable terms.
Many medical device firms face regulatory issues as a result of inadequate complaint handling. FDA has explicit complaint handling requirements and poor complaint &\; reporting procedures often result in costly recalls and warning letters. FDA warning letters and recalls are posted on FDA's website and published in trade magazines\, newspapers available to firm's competitors\, and has even driven the firm's stocks down. This presentation will review the regulations and point out some of the pitfalls in complaint handling and reporting.
Areas Covered in the Session\:
FDA's Complaint Definition 820.3 (b).
Complaint Documentation.
Part 803 - Medical Device Reporting.
Part 806 - Reports of Corrections &\; Removals.
Warning letters and other FDA Remedies.
Complaint Handling Pitfalls.
Who Will Benefit\: Some employees who wish to gain a better understanding include\:
Quality &\; Regulatory Professionals
Manufacturing &\; Design Engineers
Marketing Product Managers
Corporate &\; Operations Executives
John Chapman\, BS\, MBA\, RAC has over 30 years medical device regulatory experience and over 10 years experience with the European Union's medical device directive\, 93/42/EEC. John has led two device companies to ISO quality system certification and CE marking. He has been performed regulatory due diligence on over a dozen acquisitions in the past 12 years\, exposing him to numerous quality systems\, including consent decrees as well as many notified bodies. He earned his regulatory affairs certification (RAC) in 1998 and was a contributing author to 2004 Fundamentals of EU Regulatory Affairs\, RAPS\, 2004. He co-founded a local RAPS chapter and has been a speaker at these meetings and the annual RAPS conference.
Price List\:
Live \: $245.00
Corporate live \: $495.00
Recorded \: $295.00
Phone\: 800-447-9407
Fax\: 302-288-6884
webinars@globalcompliancepanel.com
http\://www.globalcompliancepanel.com
Every week there is an announcement about the formation of yet another Accountable Care Organization (ACO). It is reported that over 160 ACOs are in development right now – a sign that the healthcare industry is committed to improving the experience of care and the health of the population while reducing the cost of care. So where do you stand?
Are you ready to become an ACO? Are you able to determine which hospital units have the highest rate of unplanned re-admissions and then work to reduce them? Can you decrease the number of adverse events?
In this webinar\, industry leaders Richard Cramer\, Informatica’s Chief Healthcare Strategist and Maury DePalo\, Director of Edgewater’s Healthcare Practice\, will discuss the necessary steps for becoming ACO-ready by...
• Identifying and optimizing your patient base by performing patient panel analytics
• Optimizing Quality and Costs by aligning care providers and patients
• Determining accountability through the measurement of provider effectiveness.
Join us for a round table discussion on Wednesday\, August 1\, 2012 and hear firsthand how other healthcare organizations are making this journey.
END:VEVENT BEGIN:VEVENT DTSTAMP;VALUE=DATE-TIME:20130521T192400Z DTSTART;VALUE=DATE-TIME:20120802T180000Z DTEND;VALUE=DATE-TIME:20120802T180000Z UID:http://www.webinarcentral.net/content/implementing-quality-systems-based-approach-gcp-compliance-webinar-globalcompliancepanel URL;VALUE=URI:http://www.webinarcentral.net/content/implementing-quality-systems-based-approach-gcp-compliance-webinar-globalcompliancepanel SUMMARY:Implementing a Quality Systems-Based Approach to GCP Compliance - Webinar By GlobalCompliancePanel DESCRIPTION:Overview\: Ensuring GCP quality has often been approached from the perspective of reviewing as many documents as possible\, looking for errors and following up on corrections or making \\"notes to file.\\" In order to design\, implement\, and maintain GCP compliance in an effective manner\, a Quality Systems Approach should be adopted.
In the GMP and GLP domains\, this approach has led to more effective and efficient maintenance of compliance\, since only by implementing effective systems can quality and compliance be established\, monitored\, and then maintained. Your speaker will describe the GMP Quality System\, and how\, in a similar manner\, a GCP Quality System can be utilized by ensuring the proper establishment of investigator oversight and documentation\; IRB oversight\; sponsor monitoring\; corrective and preventive action (CAPA) execution\; IP controls\; Clinical Staff and lab qualification. Your speaker will discuss each sub system in detail\, why it exists\, and how working together\, they protect patient safety\, rights\, and welfare. Your speaker will present proposals for adopting this approach at clinical sites\, as well as the role of the sponsor in establishing internal GCP quality systems\, and ensuring compliance at the sites and CROs. The topic of auditing from a Quality Systems-Based Approach will also be discussed. Your speaker will also address why it is difficult to get clinical sites to use a \\"systems\\" approach and will give real-life examples of failures to deploy and implement these systems properly based on recent warning letters from FDA.
Why Should You Attend\: Many GCP compliance programs focus too much on and \\"audit and correct\\" approach. FDA takes a systems base approach towards compliance and implementation of such an approach by the Sponsor\, the CRO\, and the Clinical Site increases the likelihood of maintaining an acceptable level of compliance. In this webinar you will learn to see GCP compliance as an interaction of several sub-systems the work together to ensure patient safety and ethical treatment.
Areas Covered in the Seminar\:
Background for Clinical Trials and GCP (Good Clinical Practice)
The benefits of a Quality System approach
GCP Quality System
The Importance of the sub-systems\: PI Oversight and Record Keeping\; IRB Oversight\; Monitoring\; Clinical Staff and 3rd Party Qualification\; IP Handling\; Pharmacovigilance/Patient Safety
GCP Compliance Audits
Ranking the Severity of Observations
Resolutions of Deviations
References
Who Will Benefit\:
Auditors
Study Coordinators
Managers
Directors
Principle Investigators
Amnon Eylath is Director of Quality at Ariad in Cambridge\, Massachusetts. He is responsible for global oversight of the QA/QC aspects of Drug Substance and Drug Product Manufacturing\, Testing\, Stability\, Packaging and Distribution\, as well as oversight of compliance for Pre-Clinical (GLP) and Clinical (GCP) Studies. Amnon has over 20 years of experience in medical research\, process &\; method development\, device development\, facility/process design and validation\, GxP audits and regulatory compliance\, CMC support\, development and deployment of quality systems\, as well as disposition of Biotech and Small Molecule clinical materials for US and international use.
Amnon is currently is leading the development of a technical report on the application of cGMP and Quality Systems for the complete development life-cycle of Biotech Drug Substance\, in collaboration with industry and regulatory agency representatives. He is also a core member of industry Task Forces developing technical reports for application of GMPs to Investigational Medicinal Product\, Development of Specifications for Early Phase drug development and Risk-Based auditing. He has recently commented to changes in Eudralex regulations covering drug development. He has also lectured at Moorpark College\, UC Davis and Indiana University on Quality and Pharmaceutical Technology subjects\, and was instrumental in the establishment of the Biotechnology certification and degree programs (respectively) at Moorpark College and Indiana University.'
Price List\:
Live \: $245.00
Corporate live \: $495.00
Recorded \: $295.00
Phone\: 800-447-9407
Fax\: 302-288-6884
webinars@globalcompliancepanel.com
http\://www.globalcompliancepanel.com
Overview\: This live webinar concentrates on proper cleanroom cleaning\, and discusses tools\, equipment\, agents\, personnel training\, extent\, and frequencies.
It is a very practical training session intended to assist personnel involved in the design\, cleaning\, monitoring\, and assessment of cleanroom cleaning procedures. The key benefits of this course are\:
In-dept understanding of cleanroom cleaning methods.
Achieve satisfactory inspections more easily.
Higher assurance of new medical product approvals.
Minimize nonconformances.
Reduce rates of batch rework and rejections.
Reduce cleaning-related environmental contamination issues.
Avoid product recalls.
Understand industry standards in cleanroom cleaning
Why should you attend\: Cleanroom cleaning processes and methods have been scrutinized by FDA auditors due to their important role in cleanroom management. Poor or substandard cleaning can result in manufacturing delays\, nonconformances\, recalls\, and regulatory action. Therefore it is important to control cleanroom cleaning processes and ensure best practices are followed.
Areas Covered in the Session\:
Learn about cleaning and what it accomplishes in the cleanroom.
Identify cleaning agents\, tools\, and equipment.
Discuss cleaning personnel training and qualification.
Identify the methods of cleanroom cleaning.
Identify and discuss extent and frequency of cleanroom cleaning.
Who Will Benefit\:
Q auditors and personnel
Manufacturing Operators
Maintenance and Cleaning Personnel
Consultants
Operations managers
Microbiologists
Validation Personnel
Training departments
Charles Gyecsek is formerly of Hoffman LaRoche where he worked primarily in Validation\, Microbiology\, Quality\, and Operations. During his career Charles set-up and managed one of the largest GMP cleanroom facilities in the US\, encompassing more than 200 rooms in 3 separate facilities. Charles' extensive experience involves plant start-up\, cleanroom design and renovation\, quality system auditing\, regulatory submission writing\, microbiology\, equipment and cleaning qualification\, utility validation\, water system design and validation\, aseptic processing\, risk management\, and regulatory inspections and responses.
Charles is currently president of MIJ Enterprises whose Compliance Division provides personalized consulting and training services within FDA regulated industries pertaining to pharmaceuticals\, diagnostics\, devices\, and biotech products. Their core mission is to help clients maximize the benefit of a quality system in order to provide innovative products and exceptional services to their customers.
Price List\:
Live \: $245.00
Corporate live \: $495.00
Recorded \: $295.00
Phone\: 800-447-9407
Fax\: 302-288-6884
webinars@globalcompliancepanel.com
http\://www.globalcompliancepanel.com
Overview\: To satisfy QSR and ISO 13485 requirements\, medical device companies must respond to field reports swiftly and compliantly. There are certain circumstances in which a report from the field requires the device manufacturer to take steps regarding product in the field.
It is critical that the company take the required steps in the required timeframes. FDA and ISO requirements overlap to a great extent\, but not completely. This webinar sets forth the requirements for recalls\, removals\, and market corrections\, and provides recommended practices.
Why should you attend\: There are certain circumstances in which a report from the field requires the device manufacturer to take steps regarding product in the field. It is critical that the company take the required steps in the required timeframes. If not\, FDA's sanctions could be so onerous as to result in the company's inability to ship product.
Areas Covered in the Session\:
Regulatory definitions of recalls\, removals\, and market corrections
Instances which require recalls\, removals\, or market corrections
What to do during recalls\, removals\, and market corrections
Recordkeeping requirements for recalls\, removals\, and market corrections
ISO 13485-specific requirements
CMD-specific requirements (Canadian device regulations)
Who Will Benefit\: This webinar will provide valuable assistance to all regulated companies\, since personnel training is a regulatory requirement in the Medical Device field. The employees who will benefit include\:
Regulatory Management
Quality Assurance Professionals
Consultants
Sales/Marketing Management
Senior and mid-level Management
Quality System Auditors
Jeff Kasoff\, RAC\, is the Director of Quality at Byrne Medical\, a leading manufacturer of endoscopy and colonoscopy devices\, where he oversees the operation of the quality system. In this position\, Jeff is responsible for oversight of the document control system\, including maintenance of regulatory documentation. Prior to this\, Jeff spent 13 years at Life-Tech\, Inc. as the Director of Regulatory Affairs\, where he was responsible for compliance of the corporate quality system. Jeff received his regulatory affairs certification in 1996.
Price List\:
Live \: $245.00
Corporate live \: $495.00
Recorded \: $295.00
Phone\: 800-447-9407
Fax\: 302-288-6884
webinars@globalcompliancepanel.com
http\://www.globalcompliancepanel.com
Overview\: Cleaning validation is increasingly important in preventing cross contamination and interactions between active ingredients in subsequent batches run in the same equipment.
This webinar will review principles of sterilization validation and using them as a benchmark for more robust cleaning validation. Emphasis will also be placed on interrelationships with other processes and using the information gained during validation to monitor and control the cleaning process to prevent failure.
Areas Covered in the Session\:
Sterilization process description and validation options including the kinetics of lethality (bioindicator vs bioburden) and test methods
Pre-validation activities including defining worst case challenge to the process and selecting cleaning agents.
Aspects to consider when writing the validation protocol.
Sources of process variation and basics of process control
Data collection and troubleshooting
Post-validation (re-validation) and change control
Reporting and documentation requirements
Who Will Benefit\: This webinar will benefit any organization that wants to validate and improve the effectiveness of their cleaning processes. Those who will benefit include QA and Manufacturing Managers and Engineers who are responsible for validating cleaning or sterilization processes\, Consultants\, Auditors and responsible executives.
Tony has BS degrees in Biology &\; Microbiology and a MS in Quality Management. He is currently Quality Manager at Sealed Air\, a supplier of rigid medical device packaging solutions. Previously he was Quality Systems Manager at Davol\, Director of Quality Assurance at Scott Laboratories and Sr. Microbiologist at the National Cancer Institute. He is a Certified Quality Auditor-BioMedical and Certified Manager of Quality and Organizational Excellence by the American Society for Quality. He also teaches the refresher courses for these certification programs through the local RI-ASQ section. Tony has over 20 years experience using quality management techniques and value added auditing including the use of Failure Investigation and Root Cause Analysis to improve processes and products
Price List\:
Live \: $245.00
Corporate live \: $495.00
Recorded \: $295.00
Phone\: 800-447-9407
Fax\: 302-288-6884
webinars@globalcompliancepanel.com
http\://www.globalcompliancepanel.com
A little public relations savvy can get you valuable media coverage. Coverage that has more impact than any advert you can buy. Attend this webinar to learn\:
The power of no cost publicity and how to get it.
What stories the media want to cover.
How to target the right media.
How to write a media release.
Media interview tips.
How to use free publicity to grow your brand.
One media success often leads to another. Learn how to get the publicity ball rolling for you at this webinar.