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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 was 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)

  • US Regulatory Requirements
  • Basic Requirements
  • Product - Pre Market Requirements
  • Overview of the Quality System Regulation
  • Overview of Other Key Regulations
  • FDA Inspections
  • Post FDA Inspection Follow-up

DAY TWO (two hours)

  • Practical Application of Regulations
  • Management Controls
  • Corrective and Preventive Action
  • Complaints/Medical Device Reporting
  • Outside Resources
  • Product Labeling
  • FDA/ISO Harmonization
  • Trouble with FDA - What Next?

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 301-206-9789
  • Mail - Select and download the order form and mail with payment to:

    Executive Managment 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. For CD content questions, please contact Virginia Schoenauer at 703-525-4890, ext. 247.

*"The Silver Sheet," F-D-C Reports, April 2005, p. 1.