Post-Diploma Certificate in GxP of Quality Assurance & Compliance (QAC) (part of Specialist Diploma in Biomedical & Pharmaceutical Engineering)
About This Course
The Post-Diploma Certificate in GxP of Quality Assurance & Compliance (QAC) (PDC2 of Specialist Diploma in Biomedical & Pharmaceutical Engineering) covers the following modules (total 150hrs):
• GLP@Laboratory (30 hours)
• Industrial Safety & WSHA (15 hours)
• CAPA & Risk Assessment (15 hours)
• Integrated-Work-Study Project in Quality Assurance & Compliance (30 hours)
• Regulatory Compliance & ISO 13485 (15 hours)
• Lab Management & ISO 17025 (30 hours)
Elective Modules (select 2)
• Quality Risk Management (15 hours)
• Medical Device Design & Validation (15 hours)
• GLP Audit Management (15 hours)
What You'll Learn
• 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.
Entry Requirements
The admission requirements for public intake are:
1. Candidates should have a recognised university degree or polytechnic diploma in engineering or science or other relevant disciplines.
2. Candidates with degrees or diplomas in other (non-relevant) disciplines, who have relevant work experience (RWE) will be considered.
3. 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.