Changes in US FDA Enforcement

This FDA compliance training will discuss major changes in FDA enforcement and how the regulated industry should respond to any FDA inspection activity.

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