ACRP 2018 Meeting & Expo

100 - FDA Inspections: Understanding the Process and Managing the Consequences

Apr 28, 2018 10:15am ‐ Apr 28, 2018 12:30pm


Credits: None available.

Members: $25.00
Standard: $75.00

Description

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.

Learning Objectives:

  • Describe at least 3 regulatory actions FDA can take following an inspection
  • Discuss appropriate strategies for responding to inspection findings
  • Implement realistic and appropriate Corrective and Preventive Actions to successfully resolve inspection findings

Speaker(s):

  • Janet Holwell, CCRC, CCRA, FACRP, TIACR, Clinical Research Consultant, Independent Consultant
  • Glenda Guest, CCRA, RQAP-GCP, TIACR, Vice President, NCRA

Credits Available


FDA Inspections: Understanding the Process and Managing the Consequences

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