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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.

Contact Hours/CEUs: 2.25 (ACHE, ACRP, CME, CNE)