This course focuses on the development, implementation, and ongoing maintenance of a quality system in a cGMP environment. Topics include the cGMP standard, components of cGMP quality systems, quality function roles and training, development of documentation such as SOPs, and system review procedures. Upon completion, students should be able to identify the components of a quality system and develop a quality system manual utilizing the cGMP standard.
Total Class Credits:
2 Class Credits: 2 Lab Credits: 0 Clinic Credits: 0