Course Description
Current Good Manufacturing Practice regulations implemented to assure quality and safety of marketed products. Inspection techniques used by the FDA to ensure best practices within a manufacturer's organization, personnel, facilities, equipment, control systems, production, process controls, laboratory procedures and records, and clinical testing.
Athena Title
Current Good Manufactur Pract
Equivalent Courses
Not open to students with credit in PHAR 6030
Non-Traditional Format
This course will be taught 95% or more online. Six hours per week for fifteen weeks of online study, including teaching, assignments, discussion, problem-based learning, and case-based learning. Weekend seminar(s) totaling sixteen contact hours (onsite or GSAMS multi-point video conference) utilizing case-based and problem-based learning methods.
Prerequisite
Permission of department
Grading System
A - F (Traditional)
Course Objectives
Describe the Food, Drug, and Cosmetics Act and the FDA regulatory structure; identify device and drug GMP and state and federal requirements; explain processes used to identify new FDA initiatives and programs; write methods and procedures complying with FDA’s Good Manufacturing Practices regulations; design internal audit forms used to comply with FDA guidelines and validation procedures.
Topical Outline
FDA inspection techniques’ manufacturer best practices; FDA Drug, and Cosmetics Act; FDA regulatory structure; device and drug GMP and state and federal requirements; new FDA initiatives and programs; clinical testing, laboratory and manufacturing practice standards.
Syllabus