BQC201 Introduction to Quality Assurance/Quality Control for Drugs and Biologics

This course presents the importance and underlying principles of QA/AC. Topics include bio-safety, potency, and impurity profile issues for biologic/biopharmaceutical products; setting appropriate and meaningful product specifications and expiration dates; managing manufacturing process changes; identifying current pressures on QA/QC groups; FDA and other global regulatory expectations for GMP Quality Systems.