About Course
Course Schedule
Course Structure
Entry Requirements
Financial Matters
About Course
Course Objectives
The module will cover documentation and its role in Quality Assurance in pharmaceutical manufacturing. Documentation requirements under GMP, ISO Quality Management System, and ICH guidelines will be compared. International quality and regulatory requirements including those of the HSA will be compared. The module will cover documentation requirements for quality events including customer complaints, Out of Specifications, Deviation Investigations, Root Cause Analysis, and Corrective Action Preventative Action. The topic of documentation requirements for Qualification and Validation will cover Change Control, IQ, OQ, and PQ, method validation for incoming materials, process control, and finished product quality. The components of the QA Documentation System and Good Documentation Practice will be covered. The module will also cover Quality Audits, regulatory inspections and interpreting and responding to FDA 483 Warning Letters.Course Description
QA & Documentation - Part of Post Diploma Certificate in Pharmaceutical Quality Systems (ADMP1) is a 45 hrs module. In this module, students will learn the essential role of documentation in Quality Assurance for pharmaceutical manufacturing. They’ll explore documentation requirements under GMP, ISO, and ICH guidelines, as well as international regulations, including those from the HSA. The module covers handling quality events like customer complaints, deviations, and CAPA, alongside qualification and validation processes (IQ, OQ, PQ). Additionally, students will understand the QA Documentation System, Good Documentation Practices, and how to navigate Quality Audits, regulatory inspections, and FDA 483 Warning Letters.Course
Schedule
- Registration Period 01 Jun 2025 - 31 Jul 2025
- Course Date 20 Oct 2025 - 31 Mar 2026
- Venue NGEE ANN POLYTECHNIC
- Mode of Training Classroom
- Schedule Info Ngee Ann Polytechnic reserves the right to reschedule / cancel any programme, modify the fees and amend information without prior notice.
Time: 6:30pm to 9:30pm
Delivery mode: Classroom, Synchronous eLearning, Asynchronous eLearning
Course Structure
TPG course reference No.
TGS-2023020544
QA & Documentation - Part of Post Diploma Certificate in Pharmaceutical Quality Systems (ADMP1)
Entry Requirements
Condition 1
Highest qualification
Polytechnic Diplomaand
Highest qualification
Secondary; GCE O LEVEL; Completed; Biology, Chemistry, Combined Science, Physics, Science (Chemistry, Biology), Science (Physics, Biology), Science (Physics, Chemistry); Completed at least 1 subjects/specialisations; Minimum GPA: C6 or
Condition 2
Highest qualification
Bachelor's Or Equivalentand
Highest qualification
Secondary; GCE O LEVEL; Completed; Biology, Chemistry, Combined Science, Physics, Science (Chemistry, Biology), Science (Physics, Biology), Science (Physics, Chemistry); Completed at least 1 subjects/specialisations; Minimum GPA: C6Financial matters
Course fees payable (incl. GST & excl. supplementary fee)
Description | QA & Documentation - Part of Post Diploma Certificate in Pharmaceutical Quality Systems (ADMP1) | Total course fee |
---|---|---|
Full Course fee | $1,633.37 | $1,633.37 |
Singapore Citizen Aged 40 & Above | $163.34 | $163.34 |
PR Sponsored by SME | $170.07 | $170.07 |
Singapore Citizen Sponsored by SME | $170.07 | $170.07 |
Singapore Citizen Aged Below 40 | $245.00 | $245.00 |
Long-Term Visit Pass Plus | $1,633.37 | $1,633.37 |
Singapore PR | $1,633.37 | $1,633.37 |
GST rate
The course fees payable above are inclusive of 9% GST rate.
Payment option
The first payment needs to be made after accepting the offer.
Allowed payment by
The course fee allows to be paid by:
Post-Secondary Education Account (Adhoc withdrawal form);
SkillsFuture Credits (SFC);
Credit card (e-payment);
Debit card (e-payment);
PayNow (e-payment).
Important note: All course fees are determined based on prevailing funding policies and subject to review and revision annually.
Post-Secondary Education Account (Adhoc withdrawal form);
SkillsFuture Credits (SFC);
Credit card (e-payment);
Debit card (e-payment);
PayNow (e-payment).
Important note: All course fees are determined based on prevailing funding policies and subject to review and revision annually.
Nett Supplementary Fees Payable
- GPA Insurance Fee S$2.11,subject to GST,fees payable S$2.30 Allow payment by Post-Secondary Education Account (Adhoc withdrawal form); Allow payment by Post-Secondary Education Account (Standing order form)
- Other Fees S$7.43,subject to GST,fees payable S$8.10 Allow payment by Post-Secondary Education Account (Adhoc withdrawal form); Allow payment by Post-Secondary Education Account (Standing order form)
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.