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[NP-CQVPI-FAS] Commissioning, Qualification & Validation (CQV) in the Pharmaceutical Industry (Classroom & Asynchronous e-learning)

Offered by School of Life Sciences & Chemical Technology

Certifiable Courses

Course Schedule
About Course
Course Structure
Financial Matters
Register Interest
Area of interest
Pharmaceutical Sciences, Science

Course Schedule

Course Date: 25/07/2025 - 09/10/2025: CLOSED

Please refer to full schedule HERE

Schedule may subject to changes. Detailed timetable will only be release upon enrolment and nearer to course commencement date.
For self-sponsored applicant, you may proceed to apply after signing in with Singpass / Student ID.
For company-sponsored applicant, please approach your company HR to put in the application via the company portal using Corppass at STEP.

If you are not able to join the above course intake(s) or the course intake is currently not open for registration, please click on the "register interest" button to register your interest for the course.

By registering interest for the course, you will be notified to register for the course when the next course intake is open for application again.

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 Structure

TPG course reference No.

TGS-2025052729

Commissioning, Qualification & Validation (CQV) in the Pharmaceutical Industry (Classroom & Asynchronous e-learning)
Commissioning, Qualification & Validation (CQV) in the Pharmaceutical Industry (Classroom & Asynchronous e-learning) (NP-CQVPI-FAS)

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).

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.

Remarks

SkillsFuture Credit (SFC) can only be used to cover:
(i) Course fees payable;
(ii) Assessment fees which are part of the course;
(iii) Certification fees which are part of the course; and
(iv) GST imposed on components supported for SFC use.

Penalty charges apply if you:
(i) are absent/ no show;
(ii) withdraw from a course within 14 days of the course start date;
(iii) fail the assessment

SFC cannot be used to offset penalty charges imposed by Ngee Ann Polytechnic.