• Global Audits

Pre-PAI Readiness, an FDA-Oriented Perspective

In this paper, I will be presenting an FDA perspective on Pre-PAI readiness based on over ten (10) years as an FDA Pharmaceutical Investigator.

The objective of this paper will be to provide your firm with background information on:

  • History of the Pre-Approval Inspection Process
  • An Overview of the Process
  • PAI Preparations which you should conduct to improve your chances of a successful outcome



  • Clintrak - Jeffrey D. Coffin
    I have had the great pleasure to work with Bob for 5 years in his position of VP of Quality at Fisher Packaging Services while I acted as Director of Quality services at a sister…
See all Testimonials