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Session 19: CMC Inspections - The Pre-Approval Inspection (PAI)
Session Chair(s)
Priya Jambhekar
President
PBS Regulatroy Consulting Group, United States
- General Considerations
- What is a PAI and Objectives of a PAI?
- Timing, Preparing, and Requisite Documents for the PAI
- Creating a Strategic Plan for a PAI
- Areas and Information Subject to Inspection
- Inspectional Procedures
- General FDA Concerns
- The Exit Meeting
- Post-Inspection
- Mock CMC Inspection Exercise