About the Course
The biomedical manufacturing sector is one of the pillars of manufacturing in Singapore. This sector includes medical technology and pharmaceutical segments. According to the Ministry of Trade and Industry, it is a fast growing sector and will continue to drive manpower demand in skilled workforce to support its growth in this highly regulated sector.
The Specialist Diploma in Biomedical and Pharmaceutical Engineering (BPE) course aims to train Professionals, Managers, Executives and Technicians (PMET) in various functions such as production, project management, quality assurance, regulatory compliance and supply chain management in biomedical manufacturing sector. The course is designed in collaboration with the industry to ensure that skillsets are relevant to employers while providing participants a seamless continuation from their discipline of study to meet a cluster of job roles in biomedical manufacturing sector.
The 300-hour Specialist Diploma in BPE comprises of two 150-hour Post Diploma Certificates (PDCs):
- PDC1: GxP* of Operations Management
- PDC2: GxP of Quality Assurance & Compliance
*GxP is a general term for good practice quality guidelines and regulations. These guidelines are used in biomedical, pharmaceutical and food industries.
The Specialist Diploma in Biomedical and Pharmaceutical Engineering aims to train participants in various functions such as production, project management, quality assurance, regulatory compliance and supply chain management and to deepen their knowledge and skills in good practices of operations management, quality assurance and regulatory compliance in biomedical manufacturing sector. It focuses on integrating knowledge with practice through case-based study in class, and self-directed eLearning. Upon completion of this specialist diploma, participants will be able to:
- Apply Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP) knowledge in the manufacturing value stream of medical devices or combination products
- Employ Good Engineering Practice (GEP) and “risk-based approach” in project management within biomedical industry
- Use productivity tools and analytical skills in process improvement and trouble-shooting
- Manage Corrective Action/Preventive Active (CAPA) and apply Quality Risk Assessment (QRM) in compliance to various regulatory requirements
- Conduct quality internal audit and comply with safety requirements, Work Safety and Health Act (WSHA) at work
- Integrate knowledge and practice to develop professional competencies in operations management, quality assurance and regulatory compliance within biomedical industry
- Apply professional competencies in GxP in related industries
This course is suitable for:
- Polytechnic graduates aspiring to build a career in the Biomedical Manufacturing Sector.
- In-employment participants aiming to deepen their knowledge and skills for career advancement.
Participants will receive a Post-Diploma Certificate (PDC) upon successful completion of each semester. Participants will be awarded the Specialist Diploma in Biomedical & Pharmaceutical Engineering upon successful completion of both PDCs.