Pharmaceutical Manufacturing Lab

Catalog description

A combination laboratory and lecture course designed to provide students with an opportunity to develop hands-on experience with pharmaceutical manufacturing equipment, formulations, and common release testing procedures. Didactic sessions will focus on developing the skills necessary to perform a risk assessment (as part of a quality risk management system) and draft a batch record for routine manufacturing of a drug product. Regulatory underpinnings of these practices will be discussed. Successful completion of the course requires execution of the completed and approved batch record and characterization of a quality attribute of the product. Offered spring term, even years.