MSQ 500 - Quality Systems and Regulation

Credits: (3)
An examination of the history of the development of the FDA, the essential quality systems governing FDA-regulated industries, and the application of quality and ethical practices in the development, manufacturing, control and risk assessment of products in the biotechnology and biopharmaceutical industries. Students learn the principles of QSR (Quality Systems Requirements) as they apply to the procurement of materials and the manufacture, validation and release of products. An introduction to cGMPs (current good manufacturing practices) and other GxP concepts will also be discussed. [Online]