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.

Curriculum for this course:
Program Overview
Learning Objectives 1 min 10 secs
Who Should Take This Program? 1 min 31 secs
Glossary 1 min 21 secs
Module 1: CQV Overview
Introduction 1 min 05 sec
Regulatory Agencies 1 min 10 secs
Qualification Vs Validation 1 min 05 secs
What are the Benefits of CQV? 1 min 42 secs
Commissioning, Qualification and Validation (CQV) Planning 1 min 50 secs
CQV Master Plan 1 min 33 secs
Review Activity #1 1 min 30 secs
Module 2: Risk-Based Impact Assessment
Assessment Procedure 1 min 12 secs
Direct Impact 1 mins 29 secs
Indirect Impact 1 min 21 secs
No Impact 1 min 25 secs
CQV Activities Need Assessment 1 min 10 secs
Review Activity #1 1 min 09 secs
Review Activity #2 1 min 30 secs
Final Assessment

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