Post-Diploma Certificate in GxP of Quality Assurance & Compliance (QAC) (part of Specialist Diploma in Biomedical & Pharmaceutical Engineering)
About this course
Course objectives
The Post-Diploma Certificate in GxP of Quality Assurance & Compliance (QAC) (part of Specialist Diploma in Biomedical & Pharmaceutical Engineering) aims to train the learners on the following:Apply Good Laboratory Practices (GLP) in laboratory management in compliance to regulatory requirements.Evaluate Corrective Action/Preventive Active (CAPA) and Quality Risk Assessment (QRM) in compliance to regulatory requirements.Manage internal quality audit according to regulatory requirements at workplace.
This PDC in GxP of QAC covers the following stackable modules:
Core Modules:
• GLP@Laboratory [TGS-2024049772]
• Industrial Safety & WSHA [TGS-2024049773]
• CAPA & Risk Assessment [TGS-2024046581]
• Integrated-Work-Study Project in Quality Assurance & Compliance [TGS-2024049774]
• Regulatory Compliance & ISO 13485 [TGS-2024046583]
• Lab Management & ISO 17025 [TGS-2024046582]
Elective Modules (only select 2):
• Quality Risk Management [TGS-2024049775]
• Medical Device Design & Validation [TGS-2024049777]
• GLP Audit Management [TGS-2024049776]
Note: Only select TWO elective modules during application.
(Offering of electives is subjected to class size requirement)
Course Certification:
Post-Diploma Certificate in GxP of Quality Assurance & Compliance
(GxP is a general term for good practice quality guidelines and regulations used in medical devices, biologics, pharmaceutical and food industries)
Specialist Diploma in Biomedical & Pharmaceutical Engineering (SD BPE) is a stackable course comprising two stackable PDCs:
1) Post-Diploma Certificate in GxP of Operations Management (part of Specialist Diploma in Biomedical & Pharmaceutical Engineering) (PDC in GxP of OM) [TGS-2023018797]
2) Post-Diploma Certifucate in GxP of Quality Assurance & Compliance (QAC) (part of Specialist Diploma in Biomedical & Pharmaceutical Engineering) (PDC in GxP of QAC) [TGS-2023018798]
(Learners can enroll and complete another PDC, PDC in GxP of OM [TGS-2023018797] and stack up to the Specialist Diploma in Biomedical and Pharmaceutical Engineering)
Course description
Course Info
This stackable PDC course provides participants with an in-depth knowledge of Good Laboratory Practice (GLP) with hands-on practices in quality control of medical devices and combination products. The course will use US FDA standards such as 21CFR Part 820 and European Union regulations specifically ISO 13485 as the basis for discussions in quality assurance and regulatory compliance pertaining to laboratory operations.
Course delivery
Blended Learning with in-class and online delivery; self-directed Learning (SDL) via Learning Management System at own pace; applied Learning with real workplace problems or situated case studies; Project-based Learning (PBL) to enhance integration & application of knowledge & skills; Situated learning by participating in group discussion & sharing of experience among learners.
Stackable Programs
The Specialist Diploma in Biomedical and Pharmaceutical Engineering (SD BPE) is a stackable part-time course. By completing two stackable PDCs or 16 stackable modules (including 4 electives), learners will be awarded the following certificates:Post-Diploma Certificate in GxP of Operations Management [Course Ref ID: TGS-2023018797]Post-Diploma Certificate in GxP of Quality Assurance & Compliance [Course Ref ID: TGS-2023018798]Specialist Diploma in Biomedical and Pharmaceutical Engineering [Course Ref ID: TGS-2023018796]
(More details refer to "How to apply" and download the "HOW TO APPLY AT STEP_NYP SD BPE")
Target audiences
- University or polytechnic graduates aspiring to build a career in the fast-growing biomedical manufacturing sector.
- Working adults with years of workplace experience aiming to upskill or reskill for career development or advancement.