The Association of Clinical Research Professionals

Inspection Readiness: Best Practices for Managing Clinical Trial Inspections

Pricing With Contact Hours

Member: $22.50 | Nonmember: $149

Add to Cart

This course is approved for 1.5 ACRP contact hours. Accreditation Details

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


Pricing Without Contact Hours

Member: $0 | Nonmember: N/A

Add to Cart

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


Course Description

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 — With an eLearning Site License, your team will have access to this and 20+ more training programs covering everything from the “essentials” of clinical research to specialized topics. Delivered on our platform or for use in your learning management system.
Learn More >>

Contact Us

We’re ready to help you achieve your organization’s staff development goals.