Commissioning Qualification and Validation the Concept of CQV – Part 1

Commissioning, Qualification and Validation (CQV) activities for life science manufacturing facilities, systems, utilities, and equipment are essential for ensuring compliance to regulations and confirming that the drugs manufactured within them are fit for their intended use. International regulatory agencies have indicated in their respective guidelines and regulations that organizations must build quality into their processes and products. The purpose of this course is to explore the guidelines for CQV Activities, why they are important and how they are used to evaluate and mitigate direct or indirect risk to facilities and systems.