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.
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