BITC 1240 - Quality Assurance for the Biosciences

Credit Hours: 2
Contact Hours - Lecture: 2
Quality assurance principles and applications. Includes quality control and Federal Drug Administration (FDA) regulations to the biotechnology, biopharmaceutical, and biomedical device industries.
Prerequisite: College level readiness in Reading and Writing.
Student Learning Outcomes
1. Describe the benefits and applications of quality assurance. 2. Demonstrate proficiency in the use of the tools of quality assurance and quality control. 3. Apply sampling techniques. 4. Evaluate quality assurance standards. 5. Perform system audits and implement a corrective and preventative action plan. 6. Explain and implement GMP, GLP, and the appropriate FDA guidelines and regulations as they pertain to the bioscience industry.