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:
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:
Upon completion of this training program, participants should be able to:
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 >
Approved for 1.5 ACRP Contact Hours | Available 1 Year from Enrollment Date