Regulatory Compliance in Biomanufacturing

Catalog description

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. Students will study benchmark congressional acts (e.g. the Food, Drug, and Cosmetic Act) and the evolution of the FDA to its present state. Instructors introduce students to facilities and processes used in manufacturing and packaging drugs, biologics, and medical devices.