Post-Diploma Certificate in GxP of Operations Management (part of Specialist Diploma in Biomedical & Pharmaceutical Engineering)
About this course
Course objectives
The Post-Diploma Certificate in GxP of Operations Management (part of Specialist Diploma in Biomedical & Pharmaceutical Engineering) aims to train the learners on the following:Apply current Good Manufacturing Practice (cGMP) and Good Distribution Practice (GDP) in production operations and supply chain of medical devices or combination products according to regulatory requirementsImplement Good Engineering Practice (GEP) and Good Automated Manufacturing Practice (GAMP) and “risk-based approach” to design, plan, execute, control, validate and review a project using industry best practices.Manage various productivity and analytical tools in operational excellence in compliance to regulatory requirements This Post-Diploma Certificate in GxP of Operations Management (PDC in GxP of OM) covers the following stackable modules:
• GMP@Production [TGS-2024046572]
• GxP Project Management [TGS-2024046573]
• Computer System Validation [TGS-2024046574]
• Integrated-Work-Study Project in Operations Management [TGS-2024046575]
• Process Optimisation & Operations Excellence [TGS-2024046580]
• Good Distribution Practice & Cold Chain Management [TGS-2024046577]
Elective Modules (only select 2):
• GMP Audit Management [TGS-2024046578]
• Automated Process Design [TGS-2024046579]
• Cold Chain Validation [TGS-2024046576]
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 Operations Management
(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 Certificate 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 QAC [TGS-2023018798] and stack up to the Specialist Diploma in Biomedical and Pharmaceutical Engineering)
Course description
Course Info
This stackable PDC course provides learners with an in-depth knowledge and good practices for Good Manufacturing Practice (GMP) related manufacturing activities of medical devices and combination products with chemicals or biologics.
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.