BTEC 630. Biotechnology, Regulation, Quality Control, and Quality Assurance. 3 Hours N.

An integrated lecture and laboratory course exploring quality control, quality assurance, and regulatory considerations. Hands-on experimentation will develop a functional understanding of protocol design and a practical knowledge of GXP-guided processes. This course will focus on issues relevant to manufacturing, packaging, labeling, testing, and control of pharmaceutical products. Guest lectures from field-experts in the biotechnology industry. Prerequisite: Concurrent or prior enrollment in BTEC 599; or consent of instructor. LEC.