Changes in US FDA Enforcement

Why Should You Attend:

FDA regulated industries need to understand the new environment in the US FDA. The Commissioner has emphasized its enforcement role through additional inspection and premarket resources. The FDA also has an active program to improve its image with the public through increased publicity of enforcement activities and public information on recalls and product risks. FDA continues to petition Congress for more resources and funding to further increase enforcement activities even in an era of limited budgets. While FDA insists that it continues to support innovation in medical products, its primary publicity is in enforcement. The regulated industries need to understand the changes in the FDA environment and the impact to the industry.

This webinar will discuss the current FDA inspection and enforcement activities, and the number of personnel assigned to enforcement. The background includes the findings of Congress on perceived FDA shortcomings over the last few years to provide understanding of the new FDA. It will examine how the regulated industry should respond to any FDA inspection activity.

Areas Covered in the Webinar:

• Pressures on FDA.
• Another FDA Re-organization.
• FDA changes in focus.
• New Enforcement Resources.
• What industry should expect of FDA.
• FDA expectations for responses to FDA-483 observations.
• FDA expectations for responses to Warning Letters.

Who Will Benefit:

• FDA regulated industry Management
• Quality Management
• Regulatory Affairs personnel
• Document Control personnel
• Quality System Auditors
• Consultants

Instructor Profile:

Edwin Bills, is the Principal Consultant at ELB Consulting in the area of medical device quality, regulatory, product liability and risk management. During his 26 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 Master’s 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 the international technical committee. He has presented at training courses for the American Association of Medical Instrumentation (AAMI) in the area of risk management and quality systems.

Topic Background:

In the first major changes in FDA enforcement in 20 years the US FDA has increased its level of regulatory oversight of regulated industries. The FDA has increased its inspection force in the US and internationally as well.

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