Post-Diploma Certificate in GxP of Operations Management (part of Specialist Diploma in Biomedical & Pharmaceutical Engineering)
About This Course
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 (30 hours)
• GxP Project Management(15 hours)
• Computer System Validation (15 hours)
• Integrated-Work-Study Project in Operations Management (30 hours)
• Process Optimisation & Operations Excellence (15 hours)
• Good Distribution Practice & Cold Chain Management (15 hours)
Elective Modules (select 2)
• GMP Audit Management (15 hours)
• Automated Process Design (15 hours)
• Cold Chain Validation (15 hours)
What You'll Learn
- 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
Entry Requirements
The admission requirements for public intake are:
1) Candidates should have a recognized university degree or diploma in engineering or science, from a local polytechnic, ITE, other IHLs, or other relevant disciplines in supporting the biomedical manufacturing sector.
2) Candidates with degrees or diplomas in other disciplines, who have relevant work experience (RWE), will be considered on a case-by-case basis.
3) Candidates who do not have the necessary academic entry requirements but have substantial RWE will be considered based on Recognition of Prior Learning (RPL) with evidence of at least 5 years 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). Polytechnic reserves the right to shortlist and admit applicants.