Detailed Course Information |
Fall 2023
Oct 30, 2024 |
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| BIOT 908 - Quality Assurance and Quality Control for Biotechnology and Biopharmaceuticals |
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An examination of the application of quality practices in the development, manufacturing, control and assessment of products in the biotechnology and biopharmaceutical industries. Students learn the principles of QSR (Quality Systems Requirements) as they apply to the procurement of materials and the manufacture, validation and release of products. Through the use of case studies, the course presents the commonalities of QSR and the application of GMP (Good Manufacturing Practices) for all product types, as well as the specific requirements and differences among biologics, small molecules and devices.
Prerequisites: Acceptance into the P.S.M. program in Biotechnology or Graduate Certificate in Quality Assurance for Biotechnology.
1.000 Credit hours 4.000 Lecture hours Levels: Graduate, Non-Matriculated Schedule Types: Lecture Division of Graduate & Cont Ed Division Biology Department Course Attributes: Graduate Level Course, Quality Assrnc Biotech Certifc, MBA/MSN/PSM Programs Crs Fee, P.S.M. - Biotechnology Restrictions: Must be enrolled in one of the following Fields of Study (Major, Minor, or Concentration): Biotechnology Cert_Quality Assurance Biotech |
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