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Virtual Training Course (US Eastern Time)

Jul 13, 2020 9:00 AM - Jul 16, 2020 2:00 PM

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

Back to Agenda

Session 19: CMC Inspections - The Pre-Approval Inspection (PAI)

Session Chair(s)

Priya Jambhekar

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

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