BQC273 Advanced Quality Assurance/Quality Control for Drugs and Biologics

This course presents risk management solutions for Biopharmaceutical companies including those related to failure and Out of Specification investigations, approving validation protocols and reports, Deviations and CAPA, setting scientifically defensible specifications, GMP documentation requirements, establishing quality agreements when outsourcing, quarantine and release practices, and preparing for regulatory inspections.

Credits

3

Prerequisite

BQC 201 and BQC 271 with 'C' or better

Corequisite

BQC 275

Offered

Spring only