BTEC 2221 Regulatory Compliance in Biomanufacturing (3-0-3)

This course explores the Food and Drug Administration (FDA) and the role of Good Manufacturing Practices (GMP) compliance in manufacturing of drugs, biologics, and medical devices. Benchmark Congressional Acts (e.g. the Food, Drug and Cosmetic Act) are studied while describing the evolution of the FDA to its present state. Students are introduced to facilities and processes used in the manufacture and packaging of drugs, biologics, and medical devices.

Offered every semester

Prerequisite

Program admission