The Association of Clinical Research Professionals

FDA Inspections: Understanding the Process and Managing the Consequences

This two-part “master series” program is designed for regulatory professionals who deal with complex issues, need to understand the latest developments, and can contribute their own front-line experiences for group discussion. In the first session, speakers will cover important Good Clinical Practice topics, and preparation for audits and regulatory inspections. The second session will employ hands-on activities to create corrective and preventive action plans utilizing root cause analysis procedures to address FDA citations in warning letters and 483s.


This program is a recorded session from ACRP 2018