ALS 417A
Biopharmaceutical Quality Assurance and Control

This course will provide an introduction to the concepts and requirements for global pharmaceutical quality compliance. The course will address current Good manufacturing practices (cGMP);  Quality considerations for Biosimilars; Stability of Biotechnology products; FDA inspection processes and other quality aspects associated with the manufacture of Biopharmaceuticals. This course provides a foundational knowledge for ensuring product quality.

ALS 312

• Quality requirements for facilities, utilities, and equipment (cGMP)
• Responsibilities of management for quality review and oversight
• Stability of Biotechnology Products
• Biosimilar – Quality Considerations
• Self-audit programs and management of regulatory inspections/FDA Enforcement
• Microbiological Controls