FDA's Changing Culture: What It Means for Your Next FDA Inspection

FDA's Changing Culture:
What It Means for Your Next FDA Inspection
 


FDA Culture is Changing -  Joe Levitt, Partner, Hogan Lovells US LLP

  • Why is this occurring and what does it mean?
  • Impact on inspections
  • Impact on imports
  • Steps you need to take now

Introduction to Planning for a Regulatory Inspection - Shannon Cole & Glenn Black, GMA

  • Getting ready
  • Proactive preparation
  • When an inspector shows up at the front door...
  • FDA inspection
  • Post-event activities

Q & A session moderated by Shannon Cole, GMA