2021-2022 Academic Catalog 
    
    Mar 28, 2024  
2021-2022 Academic Catalog [ARCHIVED CATALOG]

BIOT 2000 - QA/QC: Quality by Design for Biopharmaceuticals


This course provides an examination of the application of quality practices in the development, manufacturing, control and assessment of products in the biotechnology and biopharmaceutical industries.  Students learn the principles of Quality-by-Design (QbD) and Quality Management System (QMS) as they apply them to the development of drugs from discovery to commercialization. Through sample exercises, the course presents the commonalities of QMS and the application of GxP (Good laboratory, Clinical, Manufacturing Practices) for many product types, as well as the specific requirements and differences among biologics, small molecules and devices. 

Prerequisites: BIOT 1000 - Introduction to Biotechnology  

BIOT 1200 - Business Operations Management for Biotechnology  

COMM 2100 - Scientific and Technical Communications for Biotech Industry  

Anticipated Terms Offered: spring