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FDA Inspections: Understand the Process and Manage the Consequences

This interactive 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. We will cover important GCP topics and preparation for audits and regulatory inspections. Bring your own GCP questions and dilemmas. Part 2 will employ hands-on activities to create corrective and preventive Actions (CAPAs), utilizing root cause analysis (RCA) procedures to address FDA citations in warning letters and 483s.

Speakers:

  • Janet Holwell, CCRC, CCRA, FACRP, TIACR, Clinical Research Consultant, Independent Consultant

  • Glenda Guest, CCRA, RQAP-GCP, TIACR, President, Assured of Quality Consulting & Training