BQC201 Introducation 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.
Prerequisite
Completion of a life sciences degree or Composition 1 and CEAR greater or equal to 82 or evidence of algebra-based, college level math and 12 credit hours of laboratory-based life sciences coursework within the Biotechnology A.A. program (or equivalent external program)
Corequisite
BQC 271
Offered
Fall only
Electives
- BTN - Biotech Elective
- OPEN - Open Elective