Become a member

Cart (0)

Already a DIA Member? Sign in. Not a member? Join.

Sign in

Forgot User ID? or Forgot Password?

Not a Member?

Create Account and Join

DIA Global Center

Oct 15, 2018 8:15 AM - Oct 16, 2018 3:30 PM

21 Dupont Circle NW, Suite 300, Washington, DC 20036

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

Back to Agenda

Session 23: CMC Inspections - The PAI

Session Chair(s)

Albert S. Yehaskel, MBA

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

Have an account?