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2025-2026 College Catalog > Course Descriptions > BQC - QA & CONTROL BIOTECH > 200 > BQC275

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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.

Credits

3

Prerequisite

BQC 201 and BQC 271 with a 'C' or better

Corequisite

BQC 273

Offered

Spring only