The Role of Executive Management in Quality System Compliance
In 2004, 63% of Warning Letters issued by the FDA to medical device manufacturers contained a citation for failure by Executive Management to establish an effective Quality System.*
In response to this need, AAMI offered "The Role of Executive Management in Quality System Compliance," a one-time webinar especially developed for the busy executives of medical device manufacturers — presidents, vice presidents, directors, board members, and major department heads — who are ultimately responsible for quality system compliance.
The webinar is designed to give participants:
- Insight on FDA's quality system requirements that Executive Management is responsible for overseeing in their company.
- An understanding of their obligations and responsibilities, which will help executives become aware of problems sooner, better allocate organizational resources to minimize compliance issues, and increase the likelihood of producing a safe and effective product.
- Tips on conversing with staff about their quality management system and FDA investigators during a facility inspection.
The four-hour webinar CD gives you an opportunity to hear directly from industry and FDA and listen to questions and answers from the live broadcast.
PROGRAM-AT-A-GLANCE
DAY ONE (two hours)
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DAY TWO (two hours)
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SPEAKERS
- Art Ward, President, AJW Technology Consultants
- Cecilia Kimberlin, Ph.D., Group Vice President of Quality Assurance and Compliance, Abbott
- Joseph Puleo, Chief, Technical Assistance Branch, Division of Small Manufacturers, International and Consumer Assistance, U.S. Food and Drug Administration
WEBINAR CD
- Includes handout material and CD
- $445 for webinar registrants / $545 for non-registrants
- Please note that domestic and international shipping rates apply
THREE WAYS TO ORDER
- Phone - 1-877-249-8226 / 240-646-7031 to order with credit card
- Fax - Select and download the order form and fax to 240-396-5781
- Mail - Select and download the order form and mail with payment to:
Executive Management Webinar CD Package
AAMI Publications
PO Box 0211
Annapolis Junction, MD 20701-0211
QUESTIONS?
For
questions about ordering the CD, please contact AAMI Publications at 1-877-249-8226 / 240-646-7031.
*"The Silver Sheet," F-D-C Reports, April 2005, p. 1.