Inside the FDA Inspection: Managing Interviews, Requests, and FDA 483 Risk in Real Time

Description

This course teaches participants how to manage FDA investigator interactions, document requests, interviews, and observations in a manner consistent with FDA inspection authority, procedures, and enforcement practices.

Why This Training Matters

This course shifts the focus to inspection execution and response, addressing what happens once an inspection begins and how risk must be actively managed in real time. Participants learn how FDA investigators structure interviews, request documents, and test the alignment between written procedures and observed practices. The session provides practical guidance on responding to investigator questions accurately and professionally, managing document requests without creating contradictions, and recognizing when an observation may be forming. The goal is not to script responses, but to equip organizations with the situational awareness needed to avoid common behaviors that unintentionally expand inspection scope or escalate regulatory risk.

Agenda:

Lecture 1 - The Opening of an FDA Inspection