Regulation of Pharmaceutical Manufacturing (Classroom & Asynchronous e-learning)
Training Provider: NATIONAL UNIVERSITY OF SINGAPORE
Course Reference: TGS-2024043274
S$1,620
Original: S$5,400
Save S$3,780
About This Course
This module will explain the importance of manufacturing and quality control for pharmaceuticals. Participants will learn about the strict controls and regulatory requirements, particularly on product stability and specifications, in addition to the practical skills obtained through mock reviews of dossier materials. The module closes with an emphasis on the utility of a system approach to quality control, and the new regulatory trends upcoming in this domain.
What You'll Learn
Ensuring quality of healthcare products is one of the key pillars in regulatory responsibilities, for industry, manufacturers and regulators. The contribution of Chemistry, Manufacturing and Controls (CMC) to a successful control of quality in pharmaceutical products spans from product development and manufacture, process validation to post-market variation changes, as well as an optimal quality management system.
Entry Requirements
1. Bachelor's Degree.
2. Relevant experience in the field of health products regulatory affairs
Course Details
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