About Course
Course Schedule
Course Structure
Financial Matters
About Course
Course Objectives
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.
Course Description
By the end of this course, participants should be able to:• 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
Course
Schedule
- Registration Period 29 May 2025 - 06 Jul 2025
- Course Date 25 Jul 2025 - 09 Oct 2025
- Venue NGEE ANN POLYTECHNIC
- Mode of Training Classroom
-
Schedule Info
Duration: 11 Weeks (70hrs)
Time: 6.30pm to 9.30pm
Delivery mode: (Blended) Classroom (40 hours) & Asynchronous e-learning (30 hours)
Venue: Ngee Ann Polytechnic & Online
Schedule may subject to changes. Detailed timetable will only be release upon enrolment and nearer to course commencement date.
Course Structure
TPG course reference No.
TGS-2025052729
Commissioning, Qualification & Validation (CQV) in the Pharmaceutical Industry (Classroom & Asynchronous e-learning)
Financial matters
Course fees payable (incl. GST & excl. supplementary fee)
| Description | Commissioning, Qualification & Validation (CQV) in the Pharmaceutical Industry (Classroom & Asynchronous e-learning) | Total course fee |
|---|---|---|
| Full Course fee | $3,488.00 | $3,488.00 |
| Enhanced Training Support for SMEs for Singapore Citizen | $406.40 | $406.40 |
| Enhanced Training Support for SMEs - SPR & LTVP+ | $406.40 | $406.40 |
| SkillsFuture Mid-Career Enhanced Subsidy for Singapore Citizen aged 40 and above | $406.40 | $406.40 |
| SkillsFuture Baseline Funding for Singapore Citizen Aged Below 40 | $1,046.40 | $1,046.40 |
| SkillsFuture Baseline Funding for SPR/LTVP+ | $1,046.40 | $1,046.40 |
GST rate
The course fees payable above are inclusive of 9% GST rate.
Payment option
The payment needs to be made upon the application is submitted.
Allowed payment by
The course fee allows to be paid by:
SkillsFuture Credits (SFC);
Credit card (e-payment);
Debit card (e-payment);
PayNow (e-payment).
SkillsFuture Credits (SFC);
Credit card (e-payment);
Debit card (e-payment);
PayNow (e-payment).
Refund and withdrawal policy
- Please note that a 100% refund will be available if the withdrawal request is submitted more than or equal to 14 days before the course start date.
- Please note that a 50% refund will be available if the withdrawal request is submitted less than 14 days before the course start date.
- Please note that no refund will be available if the withdrawal request is submitted on or after the course start date.