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« Wednesday June 20, 2012 »
Wed
Online Seminar Software

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

Business Mastery Series

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

Play Therapy Webinar Series

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.

Prepare for Tougher cGMP Compliance Audits - Webinar By GlobalCompliancePanel
Start: 06/20/2012 10:00 am

Overview: This webinar will examine the stated intent of the Agency to get tougher across the board in its expectations for the medical industry and its compliance to the cGMPs.

It will examine how these goals of the Agency have translated into action over the past two plus years: The changing focus of QSIT re: medical devices, and ICH Q8, Q9, and Q10 re: pharmaceuticals; Multi-site company operations, and the supply chain; Trends evident in 483 observations, Warning Letters, and recent major industry failures; Emphasis on proving a company is "in control" to an investigator's satisfaction; the negative role of "entropy", and proactive and reactive Warning Letter avoidance techniques.

Why you should attend: The last few years have seen several major "names" in drugs and devices stumble over cGMP issues, resulting in recalls, lawsuits, and even possible criminal prosecution. As a result, there has been a major shift in the emphasis of the U.S. FDA cGMP compliance audit, also affecting clinical trial expectations, product submissions and company response requirements. This change in focus has a major impact on interpretation of individual compliance objectives, cGMP objectives, and measurements of success. Recent negative publicity on pharmaceuticals, devices, as well as events in unrelated industries has put pressure on the Agency to "get tough on compliance / enforcement". The public wants change. The U.S. FDA is responding. The cGMP compliance audit, validations, 510(k) submissions / data, "better science", lifecycles, closed-loop CAPA, outsourcing / globalization and supply chain / control issues, and senior management, are all under more intense scrutiny.

Areas Covered In the Session:
The Changed / Tougher FDA.
Shifting and New Emphasis
Core Expectations
QSIT and Q10 Focus; and Q8 and Q9 "Lessons"
High Risk Areas
The Supply Chain
The Multi-Site Challenge
What Constitutes "Proof"
Addressing the On-site Audit, the 483s, the Remediation / Responses

Who will benefit:
Senior Management in Drugs, Devices, Biologics, Dietary Supplements
QA
RA
R&D
Engineering
Production

Price List:
Live : $245.00
Corporate live : $995.00
Recorded : $295.00

webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com

Phone: 800-447-9407
Fax: 302-288-6884

An Introduction to Process Validation - For Beginners - Webinar By ComplianceOnline
Start: 06/20/2012 10:00 am
End: 06/20/2012 11:00 am

This webinar will cover the basics of process validation for pharmaceutical products and give you a strong understanding of what is involved. It will provide beginners an understanding of the validation master plan, validation protocols, IQ, OQ, PQ and types of validation.

Why Should You Attend:

With new manufacturing technologies increasingly becoming a larger part of our pharmaceutical product supply, validation is gaining in importance to pharmaceutical manufacturers. Whether a firm performs its own validation, hires a validation contractor or delegates the responsibility to a third party contract manufacturer, the ultimate responsibility always falls to the firm whose name appears on the label. The only way that this can be done with confidence is to have an adequate number of validation experts on staff. Since many firms believe that they no longer need an in-house validation staff, they have done away with this overhead cost. Now it is essential to have a minimal on-site validation presence. Since there are very few validation experts today. It is often necessary to train people in this lost art.

This webinar will cover the basics of validation. This 60-minute session will expose beginners to the basics of the process and give them a strong understanding of what is involved.

Areas Covered in the Seminar:

- What is validation and why is it important
- Validation master plan
- Validation protocols
- IQ
- OQ
- PQ
- Summary Report
- Types of validation

Medical Device Supplier Quality Agreements - Webinar By GlobalCompliancePanel
Start: 06/20/2012 10:00 am

Overview: The FDA’s Quality System Regulation (QSR) explains how a device manufacturer must manage suppliers. This ranges from supplier evaluation and selection to control methods. One common approach uses a supplier quality agreement. This webinar explains the elements of a supplier quality agreement and its implementation.

Why should you attend: Effective supplier management can help prevent problems and reduce their impact should they occur. With the increased emphasis on supplier management, you can expect strong coverage of this area during an FDA Inspection.

You need to understand the QSR requirements, good business practices, and the role of a quality agreement. This webinar will help you set up an effective system.

Areas Covered in the Session:
Valuable documents that provide understanding
Quality System Regulation (QSR), including the definitions
QSR Preamble
ISO 13485:2003
FDA's Quality System Inspection Technique (QSIT) manual
Warning Letters
Subject Areas covered
QSR Requirements for Purchasing
The Supplier Quality Agreement
Administrative Elements
Compliance
Manufacturing, Packaging, and Labeling
Documentation and Records
Storage and Shipment
Change Control
Non-Conformance, CAPA, and Complaints
Auditing
For each subject area, the webinar includes information from the valuable documents listed above

Who will benefit:
Quality Managers
Regulatory Affairs Managers
Risk Managers
Supply Chain Managers
Purchasing Professionals
Supplier Management Team
Customer Complaint Specialists

Price List:
Live : $245.00
Corporate live : $995.00
Recorded : $295.00

webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com

Phone: 800-447-9407
Fax: 302-288-6884

Understanding Inattentive ADHD: Recent Updates in Evidence-Based Screening and Treatment Strategies
Start: 06/20/2012 11:00 am

Discover why Inattentive ADHD is different from other types of ADHD and learn the latest information about screening, SCT, symptomatology, comorbidities, treatment modalities, medication, and how this disorder may be mentioned in DSM-5.

Full Description:
Why is Inattentive ADHD Different? New Information
Attention-Deficit Hyperactivity Disorder, Predominately Inattentive Type is NOT a “calmer” or “lighter” version of ADHD. The neurophysiology, symptoms, treatment methods, and medications for this disorder are different than the other types of ADHD. Since patients with Inattentive ADHD are not typically as disruptive as those with other types of ADHD, this type is commonly misunderstood or goes unrealized by the mental health professional. Little research has been done compared to Combined ADHD and most seminars and webinars only spend a small portion of time on Inattentive ADHD.

This one-hour course will provide participants with the latest information about screening, Sluggish Cognitive Tempo (SCT), symptomatology, comorbidities, treatment modalities, medication, and how Inattentive ADHD may be mentioned in DSM-5.

Course Includes:
Live Q&A
Presentation Handout
Post session recording access
CE Credit

What You Will Learn:
Identify the differences between Attention-Deficit/Hyperactivity Disorder, Predominately Inattentive Type (Inattentive ADHD), and other forms of ADHD
Define treatment methods for Inattentive ADHD and how such methods are different than those for other forms of ADHD
Outline the common co-morbidities of Inattentive ADHD
Evaluate new research about Sluggish Cognitive Tempo and its relationship to ADHD
Discuss how Inattentive ADHD may be described in DSM-5

Your Presenter:
KEVIN T. BLAKE, PhD, P.L.C., is a licensed psychologist and author with over 20 years of experience as a nationally recognized authority on learning disorders and ADHD in children, adolescents, and adults. This interest spurred from his own struggles overcoming a reading disorder/dyslexia and hearing impairment.

Dr. Blake serves as a member of the American Psychological Association, International Dyslexia Association, Children and Adults with Attention Deficit Disorders, Learning Disabilities Association, and the National Attention Deficit Disorder Association and was a 1991 delegate to the National Institute for Literacy’s “LEAD 2000 Congress,” where he advised Congress on diagnostic and remediation issues.

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, School Psychologists, Guidance Counselors, Psychiatric Nurses, Nurses, Psychiatric Nurse Practitioners, Case Managers, Alcoholism and Drug Abuse Counselors/Addiction Professionals, Clergy, School Administrators, Physicians, Psychiatrists, Mental Health Administrators, Special Education Teachers, College Counselors

Last chance to Register on How to Manage a Medical Device Recall Efficiently and Effectively By compliance2go
Start: 06/20/2012 1:00 pm
End: 06/20/2012 2:00 pm

Why should you Attend:

• Create and use a recall operational procedure and what should it contain
• Understand what effectiveness checks are
• What happens in a medical device recall?
• Learn why a recall is either a correction or a removal depending on where the action takes place
• Understand what is required for the recall strategy as expected by FDA
• Source of recall authority and guidance
• Depth of recall and using a viable, sustainable and effective strategy
• Understand why the documentation and paper trail are so critical and termination of a recall
• Snapshot of most recent recalls and why the numbers are alarming

Webinar Includes:

Q/A Session with the Expert to ask your question

PDF print only copy of PowerPoint slides

60 Minutes Live Presentation

Description of the topic:

Recall means the correction or removal of a device for human use where FDA finds that there is a reasonable probability that the device would cause serious, adverse health consequences or death. It is an action taken to address a problem with a medical device that violates FDA law. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health. A medical device recall does not always mean that you must stop using the product or return it to the company. A recall sometimes means that the medical device needs to be checked, adjusted, or fixed. If an implanted device (for example, a pacemaker or an artificial hip) is recalled, it does not always have to be removed. When an implanted device has the potential to fail unexpectedly, companies often tell doctors to contact their patients to discuss the risk of removing the device compared to the risk of leaving it in place. FDA classifies medical device recalls into three categories, representing the potential risk to public health: Class I, II, and III.

Who will benefit: (Titles)

Manager, Regulatory
Director, Regulatory
Legal Counsel
Regulatory Affairs Specialist
Marketing and Sales Management
Regulatory Consultants

About Speaker

David R. Dills, Principal Consultant, PES-RAQA, Medical Device Practice, Wipro Technologies, currently provides regulatory and compliance consultative services to global medical device and pharmaceutical manufacturers, and also has an accomplished record with more than 23 years of experience with Class I/II/III medical devices, In Vitro diagnostics, and pharmaceuticals in the areas of QA, Regulatory Affairs and Compliance.
Since 2000, has provided consultative services on behalf of global manufacturers and subcontracted by third-party consultancies and provides services involving all phases of the product development, submission, and commercialization process, inspection readiness preparation, GxP/strategy/risk management, audits and regulatory assessments, remediation and regulatory strategies, postmarketing surveillance/vigilance reporting, clinical affairs, deploy and remediate Quality Management and documentation systems, preparation for ISO 13485 registration and CE Mark, and multi-country product registrations and licensing. He has been previously employed, with increasing responsibilities by medical device manufacturers and consultancies, including a globally recognized CRO.

Negative Keyword Strategies for PPC - How to Stop Paying for Unwanted Clicks and Boost Profits
Start: 06/20/2012 2:00 pm
End: 06/20/2012 3:00 pm

Negative keywords are one the most powerful tools available for marketers looking to optimize paid search and increase revenues. Join us for this FREE webcast to learn practical tips that the pros use for identifying, deploying, and profiting from negative keywords.

You will discover:

- How to identify negative keywords using data available in your enterprise today
- Advanced techniques for increasing traffic for exact match terms
- Quick and easy tips for Yahoo! | Bing negatives that increase efficiency
- How to apply these negative keywords strategies to your own campaigns immediately

Understanding and Implementing ISO 17025 - Webinar By ComplianceOnline
Start: 06/20/2012 4:00 pm
End: 06/20/2012 5:15 pm

This webinar will provide a detailed information on the critical requirements of ISO 17025 and recommendations for cost effective implementation. You will learn steps towards laboratory accreditation and how to prepare for an ISO 17025 audit.

Why Should You Attend:

ISO 17025 is used by laboratories as a standard to develop and establish a Quality System and for the assessment by their clients or by third parties. The standard is also being used as a criterion for laboratory accreditation. ISO 17025 is applicable to all organizations performing tests and/or calibrations, regardless of the number of personnel or the extent of the scope of testing and/or calibration.

This webinar gives a detailed information on the critical requirements of ISO 17025 and recommendations for cost effective implementation.

Hand-Outs:
For easy implementation, attendees will receive

  • Laboratory Quality Manual: Template and examples
  • ISO17025: Step-by-step implementation
  • 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.

    Areas Covered in the Seminar:

    • Benefits of ISO 17025.
    • Management requirements.
    • Technical requirements.
    • Documentation requirements.
    • Steps towards ISO 17025 laboratory accreditation.
    • Preparation for an ISO 17025 Audit.
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