FDA Inspection Readiness - Modular Course for Practitioners

Description

FDA inspections are one of the most consequential events in the lifecycle of any FDA-regulated organization. Whether conducted as routine surveillance or in response to a specific risk signal, an inspection represents the Agency’s formal assessment of whether a company is operating in a sustained state of control and complying with applicable requirements under Title 21 of the Code of Federal Regulations (21 CFR). For many organizations, inspections remain highly stressful events, not because of regulatory complexity alone, but because inspection outcomes often expose gaps between documented procedures, actual practices, and management oversight.

This four-module course, FDA Inspection Readiness, is designed to demystify how inspections really work by focusing exclusively on the inspection models, techniques, and expectations used by the U.S. Food and Drug Administration. Rather than approaching inspection readiness as a last-minute checklist exercise, the program reframes readiness as a continuous operational discipline rooted in data integrity, effective