This training program provides comprehensive, practical knowledge of Commissioning, Qualification and Validation (CQV) principles and practices applicable to the life sciences industry. The program covers the complete CQV lifecycle from project planning and requirements definition through commissioning, qualification, validation, documentation, risk management, deviations, change control and lifecycle management.
The program is applicable to:
The program focuses on risk-based and lifecycle-based CQV practices and provides participants with practical knowledge needed to support CQV activities in regulated life-science environments. The content is designed to be applicable across the full spectrum of life-science operations, from early-stage development through commercial manufacturing and product discontinuation.
The CQV Certified Professional program is a comprehensive online certification program designed for professionals who want to develop or strengthen their knowledge of commissioning, qualification and validation within regulated life-science environments. The program is built on industry best practices and current regulatory expectations, providing participants with both theoretical understanding and practical application skills.
The program introduces participants to the complete CQV lifecycle and explains how CQV principles are applied to facilities, utilities, equipment, manufacturing systems and computerized and automated systems. Participants will learn how to develop and review key CQV documents, assess risks, plan commissioning and qualification activities, execute Installation Qualification, Operational Qualification and Performance Qualification, manage deviations and changes, and maintain qualified systems throughout their lifecycle.
The program also provides industry-specific perspectives for pharmaceutical, biologics, ATMP, medical device and medical cannabis operations. Each module is designed to build upon previous modules, creating a progressive learning experience that develops both foundational knowledge and practical application skills. The training incorporates real-world examples, case studies, and practical scenarios to help participants understand how CQV principles are applied in actual projects.
The program emphasizes risk-based approaches and lifecycle thinking, which are central to modern regulatory expectations. Participants will learn how to apply quality risk management principles to determine the scope and extent of CQV activities, how to leverage supplier documentation and testing, and how to maintain systems in a qualified state throughout their lifecycle.
This program is intended for professionals who are involved in or transitioning into commissioning, qualification and validation roles within regulated life-science industries. The program is suitable for individuals with varying levels of experience, from those new to CQV to experienced practitioners seeking formal certification.
The program is designed for:
The program is appropriate for professionals working in both regulated industry and consulting roles. Participants should have a basic understanding of GMP principles and familiarity with pharmaceutical or life-science manufacturing operations. The program builds on this foundation to develop comprehensive CQV knowledge and skills.
Delivery Method
100% Self-Study through the Learning Management System
Participants complete the program at their own pace, with access to all learning materials, module assessments, and the final certification examination through the online learning platform. The self-study format allows participants to balance their professional development with work and personal commitments.
Assessment Structure
Each module contains:
The program contains 12 comprehensive modules, resulting in 120 module assessment questions.
Passing Requirement
To successfully complete the CQV Certified Professional certification program and earn the CQV Certified Professional Certificate, participants must meet the following requirements:
Module Assessment Requirements
Participants must complete all 12 module assessments and achieve a passing score of 80% or higher on each individual module assessment.
| Module | Assessment Questions | Passing Score | Required Correct Answers |
| Module 1: Introduction to CQV | 10 Questions | 80% | 8 out of 10 |
| Module 2: Regulatory Expectations | 10 Questions | 80% | 8 out of 10 |
| Module 3: CQV Lifecycle and Planning | 10 Questions | 80% | 8 out of 10 |
| Module 4: URS, Design Review and DQ | 10 Questions | 80% | 8 out of 10 |
| Module 5: Risk-Based CQV and QRM | 10 Questions | 80% | 8 out of 10 |
| Module 6: Commissioning | 10 Questions | 80% | 8 out of 10 |
| Module 7: IQ, OQ and PQ | 10 Questions | 80% | 8 out of 10 |
| Module 8: Facilities and Utilities | 10 Questions | 80% | 8 out of 10 |
| Module 9: Equipment Qualification | 10 Questions | 80% | 8 out of 10 |
| Module 10: Documentation and Change Control | 10 Questions | 80% | 8 out of 10 |
| Module 11: Computerized Systems CQV | 10 Questions | 80% | 8 out of 10 |
| Module 12: Life Sciences Applications | 10 Questions | 80% | 8 out of 10 |
Certificate Awarded
Participants who successfully complete all required modules and achieve the required passing score on the final examination receive the:
CQV Certified Professional Certificate
The certificate includes:
We provide training programs designed to help you meet quality and compliance standards. Our courses cover GMP, GLP, GCP, GEP, GDP, and Quality Assurance.
