Profile

The Post-Diploma Certificate in GxP of Operations Management (PDC1 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 requirements.
Implement 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

What You'll Learn

The Post-Diploma Certificate in GxP of Operations Management (PDC1 of Specialist Diploma in Biomedical & Pharmaceutical Engineering) covers the following modules (total of 150hrs):

GMP@Production
GxP Project Management
Computer System Validation
Integrated-Work-Study Project in Operations Management
Process Optimisation & Operations Excellence
Good Distribution Practice & Cold Chain Management

Elective Modules (select 2)

GMP Audit Management
Automated Process Design
Cold Chain Validation

Minimum Entry Requirement

The admission requirements for public intake are:

Candidates should have a recognised university degree or polytechnic diploma in engineering or science or other relevant disciplines.
Candidates with degrees or diplomas in other (non-relevant) disciplines, who have relevant work experience (RWE) will be considered.
applicants who do not meet the above entry requirements may be considered based on Recognition of Prior Learning (RPL) with evidence of at least 5 yeas of RWE; or supporting evidence of competency readiness. Suitable applicants who are shortlisted may have to go through an interview and/or entrance test(s). The Polytechnic reserves the right to shortlist and admit applicants.