FDA Inspection Readiness: Building a Defensible State of Control Before the Investigator Arrives

Description

This course enables participants to understand how FDA selects inspection targets, how FDA evaluates quality system health before arrival, and how to build a continuous state of control aligned with FDA expectations under 21 CFR regulations.

Why This Training Matters

This course concentrates on pre-inspection readiness—what FDA evaluates long before the investigator presents FDA Form 482. Participants explore the FDA’s risk-based inspection philosophy, including how internal Agency models prioritize sites for inspection and how seemingly minor data inconsistencies can elevate inspection scope. The session examines what FDA truly means by being “inspection ready,” emphasizing the difference between having procedures in place and demonstrating real-world process control. Special attention is given to documentation practices, investigation quality, CAPA effectiveness, and management oversight, all of which are consistently cited in FDA Form 483 observations when they fail to demonstrate control.