Edwin L Bills
Instructor Edwin L Bills
Product Id 600234
Duration 90 Minutes
Version Recorded
Original Price $295
Special Offer Price $10
Refund Policy
Access recorded version only for one participant; unlimited viewing for 6 months

Why Medical Device Companies Receive Warning Letters

Overview:

The Commissioner of the US FDA has stated the agency will be more enforcement oriented and quicker to issue Warning Letters. This presentation will review current enforcement practices of the US FDA with actual Warning Letters recently issued to medical device companies.

We will explore how the company failed to meet FDA expectations in response to inspection and other violations.  In the presentation we will attempt to determine what response by the manufacturer may have prevented the issuance of the Warning Letter. We will look at improvements to the Quality System as well as responses to the FDA-483 that was issued to the manufacturer following the inspection. The presentation will show techniques that may be used with publically available information to follow FDA's current practices and predict how the manufacturer may act to avoid a Warning Letter.



Why Should You Attend:In the medical device world, the US FDA has become more aggressive in enforcement of the regulations for manufacturers and others.  The FDA has stated they will be quicker to issue Warning Letters to device companies, and evidence shows that is the case.


Areas Covered in the Session:

  • How to Access FDA Warning Letters
  • Actual Warning Letters and what they mean
  • Why a manufacturer got a Warning Letter
  • How the manufacturer could avoid a Warning Letter
  • Interpreting FDA's current Enforcement posture from Warning Letters
  • Reviewing a manufacturer's regulatory position
  • Preparing for a visit by FDA

Who Will Benefit:

  • Quality Managers
  • Regulatory Managers
  • Internal Auditors
  • Quality Engineers
  • Regulatory Associates
  • Management Representatives

Speaker Profile
During his 20 year career in medical devices, Mr. Bills has held a number of quality and regulatory affairs positions. Mr. Bills is ASQ Certified as Quality Engineer, Quality Auditor, and as Manager of Quality/ Organizational Improvement. He also holds a certificate as Regulatory Affairs Certified through the Regulatory Affairs Professionals Society, and a BS and Masters degree from the University of Cincinnati. Recently, Mr. Bills served as US Industry Co-chair of the Association for Advancement of Medical Instrumentation committee, QM/WG04, on application of risk management to medical devices and is a current member of this group. Mr. Bills has presented at training courses for the American Association of Medical Instrumentation (AAMI) in the area of risk management and quality systems. Currently, Mr. Bills is the Principal Consultant at Bilanx Consulting LLC in the area of medical device quality, regulatory, product liability and risk management.

Sign Up for Our Newsletter