BIT 155 - Quality Control And Good Manufacturing Practices3
Course Description: The role of current good manufacturing practices (CGMPs) and a quality assurance department in the development and manufacture of quality biotechnology products. Emphasis is placed on understanding the basic principles upon which these regulations are based. Topics include the goals and obligations of the U. S. Food and Drug Administration, a review of CGMP subparts as key ingredients in the production of quality products, and the responsibilities of a quality assurance department in product quality.
Prerequisite(s): Completion of ENG 101, BIO 131, CHE 121 and TMA 100
Course Student Learning Outcomes:
- Explain the history and process of adopting and applying CGMP regulations and FDA enforcement practices.
- Deliver effective presentations using content and techniques appropriate to the biotech industry.
- Demonstrate preparedness to work in a biotech quality control department assuring compliance with CGMP at a career-ready level.
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