Inspection Readiness: Best Practices for Managing Clinical Trial Inspections
Preparing for or responding to an inspection can be daunting. Reduce your anxiety by being prepared for clinical trial inspections.
It’s best to start prepared and stay prepared. This essential training program takes you through the full cycle of a regulatory authority GCP inspection and answers key questions, like:
Why, when and where are regulatory inspections performed?
Who can be inspected?
What are the objectives of an inspection?
How do you prepare for and respond to an inspection?
The course focuses specifically on GCP inspections by the U.S. Food and Drug Administration (FDA), the Medicines and Healthcare Products Regulatory Agency (MHRA) and the European Medicines Agency (EMA), but the fundamentals can be applied to any regulatory authority inspection. Included job aids help you achieve and maintain inspection-ready status at all times:
Links to relevant websites to see common inspection findings
Tips on how to start and stay prepared for inspections
Inspector handout
Corrective and preventive action plan outline
Upon completion of this training program, participants should be able to:
Define common preparation strategies for regulatory inspections
Perform investigator/site activities required to ensure regulatory inspection readiness at any time during the conduct of the clinical trial
Perform sponsor activities required to ensure regulatory inspection readiness at any time during the conduct of the clinical trial
This course helps clinical researchers of all types build competency in Clinical Trials Operations (GCPs), Communication and Teamwork, Leadership and Professionalism, and Medicines Development and Regulation. Explore Competencies >