Work-Study Post-Diploma (Specialist Diploma in Biomedical and Pharmaceutical Engineering)

Work-Study Post-Diploma (Specialist Diploma in Biomedical and Pharmaceutical Engineering)

About this course

Course objectives

The Specialist Diploma in Biomedical and Pharmaceutical Engineering aims to deepen the knowledge and skills of participants in good practices of operations management, quality assurance and regulatory compliance in biomedical manufacturing industries.

Course description

This Specialist Diploma in Biomedical & Pharmaceutical Engineering covers the following PDCsPDC in GxP of Operations Management (150 hours): This course provides participants 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. The course will use standards from US FDA and European Union as the basis for discussions in regulatory compliance pertaining to operations management.PDC in GxP of Quality Assurance & Compliance (150 hours): This course provides participants with an in-depth knowledge of Good Laboratory Practice (GLP) with hands-on practices in quality control of medical devices and combination products. The course will use US FDA standards such as 21CFR Part 820 and European Union regulations specifically ISO 13485 as the basis for discussions in quality assurance and regulatory compliance pertaining to laboratory operations.