This FDA Compliance training will discussion on major changes in FDA enforcement and how the regulated industry should respond to any FDA inspection activity.
Why Should You Attend:
In the first major changes in FDA enforcement in 20 years the US FDA has increased its level of regulatory oversight of regulated industries.From a new Commissioner to additional inspection and pre-market resources the FDA is increasing oversight. While FDA insists that it continues to support innovation in medical products, its primary publicity is in enforcement with an active program to improve its image through increased publicity of enforcement activities and public information on recalls and product risks.
Areas Covered in the Seminar :

• Pressures on FDA.
• 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.

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