Module 5 Presentations

05/07/2024

Example of GCP/GCLP audit outcome – part of sponsor`s QMS

The Organisation for Professionals in Regulatory Affairs

63

In this presentation we will cover

• History, objectives and basic principles of GCP • Quality & Compliance & Audits & Inspections • Fraud & Misconduct in clinical research • Case studies & Examples

The Organisation for Professionals in Regulatory Affairs

64

32