Quality in Pharmaceutical Manufacturing (PME/ME/CHE560)

Detailed exploration of quality programs with specific application to the particular requirements of the pharmaceutical industry. Students will develop an understanding of the quality philosophy which drives the industry from discovery through manufacturing and of the systems and tools that are employed to implement and maintain a sustainable and successful quality system. Application of quality strategies in research and development, commercial production, computer systems, post-marketing, and other areas will be included. Case studies will be used to illustrate the challenges and issues associated with quality system deployment.