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戻る Agenda
Session 23: CMC Inspections – The PAI
Session Chair(s)
Albert S. Yehaskel, MBA
President and CEO
Refuah Global Pharmaceutical Development, Inc., 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