Quality Management integrates design, planning, execution, control, and release of a process in order to achieve a pre-determined quality level. The process can be building a facility, procuring/installing equipment, or manufacturing a product. The module offers case studies and theory, and shows how common sense and GMP essentials allow the risks of given solutions to be assessed.

Producing clinical trial supplies is an exceedingly complex business, especially if one considers going to clinics in a variety of countries and using short-shelflife materials. Starting with the Clinical Protocol, students will design a packaging configuration, plan the labelling/packaging, specify the necessary IPCs, and “release” the finished kits.