This module provides an overview of the FDA inspection process and the steps sites should take to ensure continuous readiness. Learners will explore the similarities and differences between audits and inspections, the key stages of an inspection, and the circumstances that may prompt an FDA site visit. The course emphasizes the importance of mock inspections as a tool to evaluate compliance and identify areas for improvement before an official inspection occurs.
Participants will learn how to identify necessary documentation, prepare staff and facilities, and manage responsibilities before, during, and after an inspection. The module also reviews common inspection violations, the components of a site’s response to Form 483, and how to maintain regulatory compliance through ongoing site preparedness. By the end, learners will understand how proactive organization and adherence to Good Clinical Practice (GCP) standards help ensure successful inspection outcomes and uphold data integrity and participant protection. This module is intended for all research personnel, and particularly useful for clinical research coordinator professional development.
Approximate Duration: 2 Hours
