Navigating Chemistry, Manufacturing, and Controls Through the Drug Development Process

This interactive course will demonstrate CMC sections of regulatory submissions, the FDA inspection process, and how to avoid or minimize 483s (noncompliance) using real-life scenarios.

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Session 20: 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