BTCP 105 - Good Manufacturing Practices and Quality Issues(3,0) 3 Credits
Prerequisite(s): ENGL 111 - English Composition I .
Good Manufacturing Practices and Quality Issues is a course that will expose students to the regulations and guidelines that Pharmaceutical/Biotechnology/Medical Device companies are required to follow and comply. The students will get first hand experience in reviewing and writing Standard Operating Procedures, Work Instructions, and Batch Records. The students will be exposed to the significance of Validation Protocols for equipment, processes and test methods. Proper Documentation Practices required in a GMP regulated company and widely used terminology in the workforce will be covered and exercised throughout the entire course. This course will also emphasize aseptic processing and related aspects of product quality.
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