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DIA Global Center

2017 年 09 月 11 日 8:15 上午 - 2017 年 09 月 12 日 3:30 下午

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

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

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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