BQC275 Regulatory Compliance for Drugs and Biologics
This course presents regulatory acts and requirements for industry compliance through readings, reference materials and laboratory work. Topics include the Food Drug and Cosmetics Act; the regulatory structure; GMP audits; drug GMP; quality Control testing requirements; stability testing and drug product expiry; state, U.S. federal, and foreign regulatory requirements; and reviewing and responding to an FDA warning letter.
Prerequisite
BQC 201 and BQC 271 with a 'C' or better
Corequisite
BQC 273
Offered
Spring only