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Biochemistry and Biotechnology
| Course Code |
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| Title |
Intro to Working in a Regulated Biochemistry and Biotechnology Industry |
| Course Outline |
Course Outline |
| Description |
This course will cover the basic structure of the regulated workplace; introduction to regulatory affairs, introduction to regulatory language: FDA and USDA; an overview of good practices: good laboratory practices (GLP), good manufacturing practices (GMP) and good clinical practices (GCP); introduction to quality systems: quality control, quality assurance, ISO9000, and six sigma; introduction to validation. |
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| Title |
Introduction to Validation in the Biochemistry and Biotechnology Industry |
| Course Outline |
Course Outline |
| Description |
This course provides an overview of validation in the biochemistry and biotechnology industry including biopharma, biomanufacturing, and basic and clinical research. Topics will include: 1) the science of validation; 2) qualification, calibration, and certification of equipment; 3) validation of biological assays; 4) creation and application of validation programs. |
| Course Code |
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| Title |
Intro to Quality Assurance and Quality Control in Biochem Biotech Industry |
| Course Outline |
Course Outline |
| Description |
This course covers the origins, history of quality and the major concepts, theories, principles and founders; quality planning, assurance and improvement; the roles and responsibilities of quality assurance and quality control. |
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| Title |
Ethics in the Biochemistry and Biotechnology Industry |
| Course Outline |
Course Outline |
| Description |
This course will cover ethical issues in the Biochemistry and Biotechnology Industry ranging from legal requirements for notebooks, issues with data falsification and misrepresentation, and issues of genetic manipulation and cloning among others. |
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| Title |
Internship |
| Course Outline |
Course Outline |
| Description |
This course is the required capstone experience for the Biochemistry and Biotechnology Certificate Program. An internship or work experience is required to complete the Biochemistry and Biotechnology Certificate. The experience can be a paid or volunteer experience. The experience needs to be approved by a faculty advisor in the Biochemistry and Biotechnology Certificate Program. Following the internship or work experience the student will be required to write a paper pertaining to the experience. Student must be in junior standing in a bioscience or chemistry major. |
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