The Association of Clinical Research Professionals

Inspection Readiness: Best Practices for Managing Clinical Trial Inspections

Contact Hours: 1.5 (ACRP, CBRN, ACCME)

Member: $99 | Non-Member: $149

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This eLearning course will be accessible for up to one year from the date of purchase.

Reduce your anxiety by being prepared for clinical trial inspections.

Preparing for or responding to an inspection can be daunting. It is best to start prepared and stay prepared. This essential course 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

Learning Objectives

  • 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

Audience

Clinical Research Professionals working on clinical trials subject to regulatory inspections

Bring this Program to Your Team!

Bring the quality and effectiveness of this program to your entire clinical research team! We’re ready to help you achieve your organization’s goals and promote excellence in clinical research. Get in touch today and we’ll get started!

Jenna Rouse

Director, Business Development
Talent Onboarding & Staff Development
+1.703.254.8109

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