Credit Hours:4 Lecture Hours:4 Contact Hour Total:64 This course introduces the student to the theory and application of CGMP procedures and documentation. The course will cover a brief history of events that prompted drafting and implementation of GMPs regulations, and associated documents required for a firm to comply with these regulations. The course will cover documentation associated with the implementation of a therapeutics manufacturing firm’s Quality Systems program such as: SOPs, deviations, Corrective and Preventative Action (CAPA), and Calibration programs. This course is intended to prepare the student for operations in a FDA regulated environment. Prerequisite(s): TSI College Ready in Math, Reading, and Writing. Texas Higher Education Coordinating Board Workforce Education Course Manual (WECM) course