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[NP-AMP1-24] QA & Documentation - Part of Post Diploma Certificate in Pharmaceutical Quality Systems (ADMP1)

Offered by School of Life Sciences & Chemical Technology

Advanced Diploma

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

Course Schedule

Class Day(s): Mon- Fri (3 to 4 evenings per week)
Time: 6:30pm to 9:30pm
Delivery mode: Classroom, Synchronous eLearning, Asynchronous eLearning

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 Structure

TPG course reference No.

TGS-2023020544

QA & Documentation - Part of Post Diploma Certificate in Pharmaceutical Quality Systems (ADMP1)
QA & Documentation (NP-013218)
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.

Entry Requirements

Condition 1

Highest qualification

Polytechnic Diploma
and

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 Equivalent
and

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

Financial 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 $122.63 $122.63
PR Sponsored by SME $127.89 $127.89
Singapore Citizen Sponsored by SME $127.89 $127.89
Singapore Citizen Aged Below 40 $186.39 $186.39
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.

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.

Remarks

Company Sponsorship

If your employer is sponsoring your course fee, please refer to this guide to link your company's Corppass to the STEP Corppass e-Service first. Your company will need to generate sponsorship link for you to register for the course.

For more details, please refer to the step-by-step guide to enrol, track and manage employee's learning activities and other services.