CD: RA/QA Influence                                                      

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Teleconference Recording
Sponsored by Compliance-Alliance

Recorded Thursday, April 28, 2005

Background
    This February, 1,024 drug and device professionals responded to a survey on the influence of the RA/QA function. They told us about the challenges they faced in getting other departments to comply with FDA's regulatory requirements. Over 800 people made suggestions on how to overcome those challenges. Nancy Singer , president of Compliance-Alliance, analyzed the suggestions and is offering a teleconference to provide the results.

What Will Happen During the Teleconference:
    A distinguished faculty will present a checklist based on the respondents' suggestions with over 35 ideas to help RA/QA professionals motivate others to comply with regulatory requirements. Areas include:

  • 4 ways to promote compliance in your business culture

  • 4 ways to make compliance part of everyone's job 

  • 5 characteristics of an effective RA/QA professional 

  • 7 ways to educate staff on regulatory requirements

  • 5 convincing arguments to sell the benefits of regulatory compliance

  • 3 critical ways to get other departments to cooperate

  • 5 creative use of internal audits

  • 3 methods to communicate the consequences on non-compliance

The Presenters:
A diverse faculty, whose credentials are listed below, will provide insights on how to employ each of the ideas in the checklist.

Nancy Singer has spent more than 20 years educating regulatory officials. Her background as a prosecutor helped her appreciate the consequences for individuals and firms of not complying with regulatory requirements.

Ron Johnson, Quintiles Consulting, was FDA's Director of the Office of Compliance for CDRH. While at the FDA, and in his present capacity, Mr. Johnson helps firms achieve corporate compliance.   

Dick DeRisio is vice president, quality assurance & regulatory affairs for Kinetic Concepts, Inc. Previously he held positions at companies such as STERIS Corporation, Johnson & Johnson and Pfizer.

Jim Dickinson has written about the FDA for over 35 years.  His publications (FDA Webview, FDA Update, and FDA Review) provide an analysis of the FDA initiatives and the actions taken by the Agency against firms and individuals.

George Burditt, Bell Boyd and Lloyd, has advised firms on their obligations under the FD&C Act for over 50 years. He successfully defended individuals and firms in criminal prosecutions and 305 hearings (Abbott Laboratories, Medtronic).

Fran Akelewicz has worked at drug, device, and IVD firms such as BD, CR Bard, Sterling Drug, and Boehringer Ingleheim.  Her positions include VP Quality Systems, Worldwide Director of Quality Management and Regulatory Affairs, Corporate Director of Quality Systems.

Order the Audio CD -- $95

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