Regulatory Strategy: FDA Inspection Preparation, Coaching and Management

Preparation for the next FDA Inspection.

Some of the key needs in preparing for the next FDA Inspection include:

  • Developing a FDA Preparation Strategy
  • Reviewing actions taken to address any previous FDA findings
  • Deep dives into the objective evidence to support the actions taken (or planned)
  • Interviews with Subject Matter Experts and key personnel – to rehearse them for the FDA Inspection
  • Performing a Mock Inspection to test-out the personnel, the evidence and all related logistics needed in a real inspection
  • Preparing reports and strategies to address any gaps found during the Inspection Preparation activities


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