This 90-minute webinar will help you understand the competence and training requirements in the Quality Management Systems for medical devices, especially FDA QSR, ISO 13485, and even ISO 9001.

Description:
FDA QSR states, “Each manufacturer shall have sufficient personnel with the necessary education, background, training, and experience to assure that all activities required by this part are correctly performed.” The corresponding requirement in ISO 13485 and ISO 9001, says, “Personnel performing work affecting conformity to product requirements shall be competent on the basis of appropriate education, training, skills, and experience”.

An FDA Inspection or a Notified Body audit will cover the methods you established to determine competency, evaluate employees, and take actions. All of these activities require objective evidence, in the form of records, to demonstrate your QMS operation.

Learning Objectives:
* State the four elements of competency.
* State the definitions and the “official” sources.
* Describe the contents of a job description.
* Understand the elements of a competence gap analysis.
* Describe the content of a training record and its relationship to competency.

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!

This DMFs (Drug Master Files) training will discuss the current review and enforcement climate within FDA and the manner in which drug master files (DMFs) are reviewed by FDA personnel. Besides the US, the use of DMFs in the EU, Japan, Canada and Australia will also be discussed. Similarities and differences to the U.S. system will be highlighted.
Upon completion of this course, attendees will understand how to prepare and file DMFs with the FDA and the rationale behind doing so. Participants will gain practical knowledge about what reviewers look for in DMFs, the consequences that can be expected as a result of non-compliance, and strategies for avoiding the most common DMF-related errors. The course will also emphasize the "organic" nature of DMFs , present strategies for establishing and maintaining effective change control programs , along with facilitating effective communications with regulatory agencies and your own customers and vendors.

Why Should You Attend

This course provides attendees with an understanding of the role DMFs play in the FDA's regulatory approval process for drugs and biologics. The DMFscourse will take participants through a step-by-step process of DMF preparation and explain the types of information essential for any Drug Master File. Additionally, this course explains why "one size does not fit all" and emphasizes the importance of customizing DMFs in both preparation and maintenance for particular products and businesses.

The course offers methodologies and techniques on:

Who really needs a DMF and why?
The various types of DMFs - which is best for your products.
The relationship between DMFs and drug and biologics applications.
The symbiotic relationship between DMFs and current Good Manufacturing Practices (cGMPs).
Common DMF errors - how to avoid them.
How to deal with deficiency letters and their origins.
Effective change control strategies.
Ramifications of inadequate preparation and/or maintenance and recent enforcement actions and inspectional trends.

Seminar Agenda
What are DMFs?
Types of DMFs (Types II, III, IV and V)

The rationale and preparation process for DMFs
Why DMFs are important to you and your company
How DMFs fit into FDA's regulatory processes for review of drug and biologic applications
Why, more than ever, you may need DMFs to maintain current supplier agreements as well as to develop new business relationships
What not to include

DMF Preparation: What you need and why you need it

The essential components of all DMFs, including:
The relationship between DMFs and cGMPs
Tactics for avoiding the most common DMF-related errors
Tactics for dealing with unique or novel situations/unfavorable reviews
.
FDA Review: How FDA reviews DMFs and why.
What you should expect throughout the DMF preparation and filing process
How to communicate and work with FDA to ensure success

Components Associated with a DMF:
DMF vs. Application
Acknowledgement Letter
Letter of Authorization
Changes to a DMF
Annual updates
Obligations of a DMF holder
Transmissions - transmittal letter
Deficiency letter
Auditing Vendor
Inside tips
Changes to DMF system in last 10 years
Binder specifications and cover sample

Japan DMFs
European DMFs
Canadian DMFs
Change control and maintenance: Why accurately maintaining your DMFs is important
DMFs as "living" documents. DMF updates and amendments
Types of DMF-related changes that impact drug/biologic applications: production facilities, composite materials, manufacturing processes
What you must report and to whom - the importance of establishing communication pathways with regulatory agencies, customers and vendors

Who Will Benefit:

This course is developed for those involved in the manufacture of pharmaceutical and biologic products, components, and packaging materials. The course will be especially useful for personnel responsible for:

Manufacturing
Regulatory Affairs
Research and Development
Quality Assurance & Control
Validation
Development and Preparation of Submission Materials

About Speaker

Robert J. Russell, is President and CEO of RJR Consulting, Inc, a leading Global Regulatory Consulting firm focusing on assisting the Life Science Industry. Prior to founding the firm in 2000, Mr. Russell had over 27 years of experience in CMC, Global Business Development and Regulatory Compliance for pharmaceuticals, biologics, medical devices and combination products. The company has an office in Brussels, Belgium where they interact with the European Commission and the Competent Authorities across the EU. Country establishment, marketing authorizations, variations and license renewals are core competencies of the course director. Mr. Russell has received a B.S. and M.S.in Chemistry.

Why Should You Attend

This webinar is focused on understanding the requirements of the Medical Device Directives, their linkage to the EU Clinical Trial Directive and the requirements of CE Marking and ISO Certification on commercializing products. The course covers all relevant topics in brief associated with the Directives and Guidance Documents, the reasons behind their introduction and a review of methods for effective implementation.

Key Topics to be Discussed:

The current regulatory situation in relation to Medical Devices in the EU.
The purpose of the Medical Device Directives.
Meeting the New Requirements for Conformity Assessment by Product Type.
Understanding the impact the Directive will have on developing and marketing new Medical Device products.
An overview of key areas of the Directive:
Scope of application and definition
Essential Device Requirements
Medical Device Type & Process Path
Medical Device Technical File
Clinical Investigation Requirements
Clinical Evaluations
Notified Bodies involvement
Gain a detailed understanding of all Guidance Documents available to assist in the implementation of these directives.

Detailed Agenda of the Session

Definition: Medical Device or Personal Protective Equipment.
Overview of the Global Medical Device Industry
Standard
Active Implanted
In Vitro Diagnostic
Combination Products; Drug or Biologic + Device- Interface with Other Directives and How It’s Treated from a Regulatory Perspective
An Overview of the Medical Device Directives.
Development, aims, implementation and update of the Medical Device Directives
Implication of an EU Directive vs. Regulation
Medical Devices (MDD), Active Implanted Medical Devices (AIMDD), In Vitro Diagnostic Medical Devices (IVDMD), Combination Products
Update on the additional guidance documents relating to the directives
Essential Requirements
Classification of MD's and Process Implications
Conformity Assessment
Technical File
Relationship to EU Clinical Trial Directive
Guidance Documents.
Medical Device Directive Annexes.
Compliance Requirements by Type
Full Quality Assurance System
Declaration of Conformity
Safety.
Medical Device Vigilance System
Manufacturer's Requirements
GMP
GCP
CE Marking
ISO Certification
Clinical Trials
Labeling
ISO Standard Certification.
Overall process; Management Commitment & Involvement
Role of Notified Bodies
Relationship to CE Marking
ISO-13485 (Manufacturing) & ISO-14155 (Clinical Investigation & Evaluation) Overview, Conformity, Auditing and Harmonization to International Standards
ISO-14155 Medical Device Clinical Investigations.
Part I- Clinical Studies
Part II- Clinical Investigations
Linkage to EU Clinical Trial Directive; What Does & Doesn't Apply
Compare & Contrast EU & FDA Procedures and Requirements.
Process Similarities & Differences
Implications for Industry
Company Management
Process Changes
Management Team Effectiveness
Regulatory Approval and Liaison with Regulators.
EU Co-Decision Procedure
Committees, Working Parties Relevant for Medical Devices
When and How to Influence Regulators
Do's and Don'ts of Regulatory Involvement
Individual Company Involvement vs. Trade Association

Learning Objectives

Upon completion of this course attendees will have a thorough knowledge of the requirements for developing and marketing Medical Devices across the European Union. The Directives are complex and the requirements differ somewhat by Member State. The content of this course is designed to simplify the understanding of all requirements and to provide attendees with the latest information regarding interpretation and enforcement of these regulations.

Who Will Benefit

This workshop will be of great value to Medical Device professionals and those involved in the registration of Medical Devices across the EU. It is primarily designed to benefit the following disciplines:
Clinical research and medical operations
Project Managers
Product Development personnel
Manufacturing personnel
Researchers managing Medical Device R&D and Development
Quality Assurance such as GMP, GCP Auditors
Regulatory affairs
Clinical trial supply personnel
CRO personnel
All personnel who need to understand the procedures and impact of placing Medical Devices on the Market in the EU (30 expanded EEA countries)

About Speaker

Robert J. Russell, is President and CEO of RJR Consulting, Inc, a leading Global Regulatory Consulting firm focusing on assisting the Life Science Industry. Prior to founding the firm in 2000, Mr. Russell had over 27 years of experience in CMC, Global Business Development and Regulatory Compliance for pharmaceuticals, biologics, medical devices and combination products. The company has an office in Brussels, Belgium where they interact with the European Commission and the Competent Authorities across the EU. Country establishment, marketing authorizations, variations and license renewals are core competencies of the course director. Mr. Russell has received a B.S. and M.S.in Chemistry.

This 90-minute webinar will review the top HIPAA security issues that health information professionals face - encryption and mobile devices, remote access, disaster recovery, policies and procedures, documentation and training - and show what they have to do to mitigate the risks they present.

Why Should You Attend:

Many organizations are taking a serious look at their HIPAA compliance status now that HHS HIPAA compliance audits are taking place, and there are several security risk issues that most health care providers are wrestling with. This session presents the top six issues found in HIPAA security compliance: encryption and mobile devices, remote access, disaster recovery, policies and procedures, documentation and training.

The session will include an explanation of why HIPAA Security Rule compliance is of interest today, what can happen when compliance is not in place, identification of the top six risk issues, a discussion of staff-related issues, and identification of strategies for risk mitigation. Dealing with the risks means new policies and procedures, new documentation, and new training, but it can't be postponed any longer, as fines have been increased, including a new minimum $10,000 mandatory fine for willful neglect of compliance. Find out what are the biggest risks facing every manager of health information and health information systems, and what can be done about them.

Learning Objectives:

• Learn about the typical risk issues and how they are related.
• Find out how to deal with risks associated with portable data.
• Learn what goes into good policies and how to organize them.
• Find out about security awareness and training strategies that work.

Description

New 21 CFR Part 11 regulations and how to comply with them.

Why should you Attend

With the growth of the Pharmaceutical and Biotechnology industry, audits get more and more frequent. The complexity of the investigational products and of the clinical trial protocols amplified the risks for noncompliance. Noncompliance in clinical trials and misreporting of clinical trial results that took place in the last years made the regulatory bodies to multiply the number of audits. On the other part, the sponsors also multiplied the audits from their part in the idea to try to downsize the risk of noncompliance during the trial. This presentation will help with preparing the site and the study team with how to comply with the new 21 CFR part 11 regulations, how to identify risk of noncompliance, and how to insure compliance.

Areas Covered in the Session

Learning about preventing noncompliance during the clinical trial development and about preparing well for an audit.

Who will Benefit: (Titles)

Clinical trial sponsors study team
CROs study team
Study managers
Clinical team leads
CRAs
Principal investigators, site managers and study coordinators
IT and Data Managers

About Speaker

Calin Enea Popa, MD, CCRA is the Founder and President of Advanced Clinical Research Service Inc. a Canadian clinical research consulting company that provides training to FDA and Health Canada regulated industries. He provides ICH-GCP training and training for FDA and Health Canada regulations. He conducted visits for Pre-Study Site Qualification, Initiation, Monitoring and Close-Out for the purpose of compliance review, drug accountability, site management, safety review, training site personnel, and to assure the integrity of clinical data. Conducted visits to train new CRAs (sign-off visits) and performed online training for CRAs and site staff regarding regulatory compliance and Electronic Data Capture. He works close wih companies and sites to prepare them for audits. He holds the CCRA certification from and is an active member of the Association of Clinical Research Professionals.

Hello Everyone,

I wanted to give everyone the chance to join a free webinar packed with information about video marketing and how to make sales in this industry.

Time and Date: October 12, 2011 6:00 PM - 7:30 PM PDT

Hosted by Blake Goodwin. He is an entrepreneur and CEO of Video Optimize LLC specializing in Video Marketing for small businesses. He is giving away trade secrets and showing people how to start their very own marketing business. If you are interested in attending and want to sign up please go to http://www.blakegoodwin.com/join

There is a limited number of seats so please join early. If the webinar is full, I will post a message on the page linked above to let you know.

Note: This webinar starts at 6:00PM PST. This is not in the morning despite what it says in the title.

Overview : Workplace violence is the number one cause of workplace fatalities for women. Eighteen thousand weekly workplace assaults cause 500,000 employees to lose 1,751,000 days of work annually, with a loss of $55 million in wages (3.5 days per incident); in fact, 18% of all crimes occur in the workplace.

Although workplace violence might seem to happen at random, there are often patterns and warning signs that indicate when violent reactions are imminent. Have your managers and supervisors been trained to recognizing those patterns and their associated warning signs? Do they know how to take preventive measures to keep violence from occurring in your workplace? In this program, you will learn about the causes and warning signs of violence in the workplace, the employer's legal duty to provide a safe workplace, responses to violent or threatening behavior at work, and more.

Areas Covered In the Seminar:

Define workplace violence and explain the four categories of workplace violence
Present key facts about workplace violence
Discuss do’s and don’ts when dealing with potentially violent individuals
List risk factors for potential violence at the workplace
Describe specific ways to respond to escalating behavior
Prioritize post-incident reporting and response procedures
Describe the key elements in a workplace violence prevention program

Who will benefit:

Chief Human Resource Officers
Senior Management Team
HR Managers, Directors, and Administrators
Supervisors
Employment Managers
Training Director

Price List:
Live : $145.00
Corporate live : $595.00
Recorded : $195.00

Overview : This webinar exposes employers to the most important state and federal (ergonomics and related) regulations existing today and workers' compensation legislations that impact how work injuries are managed.

The program will explore the science of ergonomics including the primary and secondary risk factors that are important in preventing cumulative trauma, repetitive motion injuries and other musculoskeletal claims.

Why should you attend: Steven Covey, author of "The 7 Habits of Highly Effective People" said that in order to gain control over problems, you must first seek to understand the problem. Then it will be understood what is needed to manage it better. Work injuries are no different. Many employers disregard the importance of actively managing their workers' compensation because they don't seek to understand the root cause of the problem. Many assume that workers’ compensation is a cost of doing business; that their worker' compensation insurer or third party payer will do the job they were hired to do and that the physician managing the employee's injury will do their part to manage the medical care properly. Unfortunately, that is not the case. When it comes to work injuries, the Employer should be the main one in the driver's seat managing the care of the claim, directing the other players on how to best manage it to incur the least impact. This is best done by understanding the root cause of musculoskeletal disorders.

Areas Covered in the Session: The discussion will introduce employers to the importance of establishing an Ergonomics Process for integrated disability management which includes the prevention of injuries, management of workers' compensation claims and chronic impairments that result in long term disability. Successful outcomes of ergonomics process case studies will be discussed addressing an individual case in which ergonomics was used successfully and from a process oriented approach resulting in employers' saving millions of dollars in claim prevention and management. If you want to get a handle on how your company manages its work injuries, this webinar will give you the insight you need to change the way you and your employees' work.

Who Will Benefit:

Human Resource Managers
Safety Directors
Risk Managers
Benefits Professionals
Insurance Claims Representatives and Adjusters
Business Owners and Managers
Controllers
CFOs
Attorneys
Occupational Health Care Professionals

Price List:
Live : $145.00
Corporate live : $595.00
Recorded : $195.00

Overview : Every manager encounters employees who cross the line into unacceptable behavior. Maybe they tell off-color jokes. Spread gossip. Act like slobs. Practice poor personal hygiene. Ridicule core organizational values. Or violate company rules and policies.

Lots of managers don't have the toolkit to confront dysfunctional employees so they practice avoidance, which erodes morale and - worst of all - destroys their own credibility. Great managers recognize that putting a stop to unacceptable behavior requires a complex mix of communication skills, persuasion, intuition, toughness and credibility. They know how to probe for the reasons behind the behavior, anticipate reactions, manage expectations, seek alignment, set boundaries and hold people accountable. When bosses learn how to confront employees effectively, they create a culture where lines are clearly drawn, and bad behavior is instantly recognized by all as unacceptable. In this 90-minute webinar.

Areas Covered In the Seminar:

How to spot and stop problematic behavior early – before it takes firm root in your workplace
The most common behavior-, conduct-, and appearance-related issues managers should be able to identify and prepared to address
The key areas to focus your time and attention to prevent bad behavior from permeating your workplace in the first place
Strategies for getting to the bottom of the negative attitude or conduct – and why this is so important
How to communicate effectively - and constructively - with the offender, including how to provide candid feedback without fueling his or her contempt
How to use positive reinforcement to get naysayers on board with the rest of the team
The difference between counseling and disciplining, and how to tell which is appropriate for the circumstances presented
How to engage in difficult conversations, whether the employee is a rampant gossiper, a chronic complainer, an inappropriate dresser, or another type of behavior/conduct offender
The importance of progressive discipline, and why it's important to explain the consequences the employee may face if he or she fails to make an attitude adjustment
How to know when it's time to fire a "bad apple" employee – and how to go about it to reduce your risks of a lawsuit

Who will benefit:

Chief Human Resource Officers
Senior Management Team
HR Managers, Directors, and Administrators
Supervisors
Employment Managers
Training Director

Price List:
Live : $145.00
Corporate live : $595.00
Recorded : $195.00