Human Behavior Under FDA Scrutiny: How Words, Actions, and Reactions Shape Inspection Outcomes

Description

This course enables participants to understand how individual and team behavior influences FDA inspection outcomes, and how investigator interactions, verbal responses, and day-to-day conduct are evaluated as evidence of system control.

Why This Training Matters

This course focuses on the human and behavioral dimension of FDA inspections, recognizing that inspections are not evaluated solely on documentation and procedures, but also on how people demonstrate knowledge, control, and accountability in real time. FDA investigators routinely assess credibility, consistency, and competence through interviews and informal interactions, often using employee responses as evidence of whether quality systems are truly understood and effectively implemented. This session explains how FDA interprets verbal responses, body language, and decision-making behavior as extensions of the quality system itself.

Agenda:

Lecture 1 - FDA’s View of Human Behavior as Evidence