The FDA Group’s CEO, Nick Capman, sits down with Former FDA Investigator, Christopher Smith to dive deep into FDA Pre-Approval Inspections (PAIs). Chris has more than 35 years of experience having held senior positions at the FDA, large and small pharmaceutical companies, and contract research organizations. 

Learn how PAIs are planned and conducted, how to prepare for them, and where to go to find helpful resources your team can utilize. Need expert help with PAI preparation? Connect with The FDA Group to schedule a mock PAI or discuss other quality and compliance support. Learn more about our GMP Auditing services here.