Introduction to QA/QC for Drugs & Biologics

This introductory course in Quality Assurance/Quality Control (QA/QC) for Drugs & Biologics provides guidance in the following areas: 1) understanding the importance and underlying principles of QA/QC; 2) developing a cost-effective, risk-managed QA/QC strategy for products through the different phases of clinical development and into commercialization; 3) handling biosafety, potency, and impurity profile issues for biologic/biopharmaceutical products; 4) setting appropriate and meaningful product specifications and expiration dates; 5) managing manufacturing process changes; 6) identifying pressures on QA/QC groups today; and 7) meeting FDA’s expectations for the role of Quality Systems.

Course Number: BIOL-40038   Credit: 3 units

This course is part of the following Certificate Program(s):

• In Vitro Diagnostics

• Quality Assurance and Control