Commissioning, Qualification & Validation (CQV) in the Pharmaceutical Industry (Classroom & Asynchronous e-learning)
About This Course
The Commissioning, Qualification, and Validation (CQV) course is designed to equip professionals with essential skills for the pharmaceutical manufacturing and biotech industries. Tailored to meet the stringent requirements of Singapore’s growing biotech sector, this course delivers a comprehensive curriculum covering both foundational and advanced aspects of CQV.
Participants will gain expertise in implementing Process Analytical Technology and managing process quality, equipping them to uphold and enhance quality standards. The curriculum includes in-depth training on quality assurance, audit practices, and risk analytics to ensure compliance with international regulatory expectations. The course also covers process development management, improvement, and optimization techniques, enabling participants to streamline manufacturing workflows. Participants will also explore automated process design and control and paperless validation using Kneat software for workflow digitalization to meet the demands of modern, high-tech facilities. Knowledge in cleaning validation and good manufacturing practices (GMP) will ensure participants are well-prepared to support efficient, compliant, and high-quality production environments.
This course comprises 40 hours of in-person practicum sessions to bridges the theory delivered via 30 hours of online asynchronous lectures with real-world application, led by experienced trainers with deep industry experience.
What You'll Learn
• Understand the key aspects of a Pharmaceutical Quality System and how it is implemented in the pharmaceutical industry
• Understand the key aspects of Quality Risk Management and how it is implemented throughout the Process Validation lifecycle
• Understand the principles and regulatory expectations (as dictated by Food and Drug Administration (FDA), Energy Market Authority (EMA) and International Council for Harmonisation (ICH) behind Commissioning, Qualification & Validation (CQV)
• Understand the different phases of the Process Validation lifecycle
• Understand the concept of Quality by Design and apply it to Process Design
• Understand the key considerations behind Facility and Equipment design
• Be able to write a Validation Master Plan and plan the required validation activities
• Be able to plan and execute CQV protocols and write the relevant reports
• Learn how to use Kneat to perform paperless CQV
• Understand how to plan and execute Cleaning Validation
Entry Requirements
Nil