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Managing the Consequences of Audits and FDA Inspections

This interactive session is intended for experienced professionals who deal with complex clinical trials issues focused on during U.S. Food and Drug Administration (FDA) audits and inspections, need to understand the latest developments, and can contribute their own experiences. Presenters will cover important Good Clinical Practice topics to prepare for audits and regulatory inspections and for addressing any resulting observations. The presentation will be followed with hands-on activities to create corrective and preventive action (CAPA) plans, utilizing root cause analysis procedures to address FDA citations in Warning Letters, Notices of Initiation of Disqualification Proceedings and Opportunity to Explain, and Form 483s (Notice of Inspectional Observations). Tools will be provided and participants will work in groups. The session provides an opportunity to collaboratively hone skills in problem solving and root cause analysis, resulting in effective CAPA plans.

CEU: 1.00 ACRP

Speakers: