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May 03, 2024
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2022-2023 Catalog [ARCHIVED CATALOG]
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BIOT 102 - Survey of Good Manufacturing Practices
PREREQUISITES: Demonstrated competency through appropriate assessment or earning a grade of “C” or better in ENGL 093 - Introduction to College Writing , and ENGL 083 - Reading Strategies for College , or ENGL 095 - Integrated Reading and Writing , or ENGL 075 - Co-Requisite Integrated Reading & Writing ; and MATH 023 - Essentials of Algebra or MATH 080 - Mathematical Principles .
PROGRAM: Biotechnology
CREDIT HOURS MIN: 3
LECTURE HOURS MIN: 3
DATE OF LAST REVISION: Spring. 2017
Students will be introduced to the basics of manufacturing within the biotechnology industry, gaining an understanding of the work environment. Students will learn a brief history of the Food and Drug Administration, then will learn how the practices set forth by the FDA control the work environment and the behavior of workers in the field. This course prepares students for the most basic entry level position in this regulated industry.
MAJOR COURSE LEARNING OBJECTIVES: Upon successful completion of this course the student will be expected to:
- Understand the unique manufacturing environment as well as the special terminology used in the biotechnology industry.
- Identify the steps of the basic product life cycle (manufacturing and regulatory) for pharmaceuticals and medical devices.
- Know the history of the current regulatory environment for the biotechnology industry.
- Understand CGMPs and how they form the industry environment.
- Understand how the CGMPs and the nature of biotechnology manufacturing result in a unique work environment.
- Understand what is done to prevent contamination, both in the work environment and the individuals working in that environment, and the consequences of contamination through hands-on lab activities including environmental monitoring, aseptic gowning and aseptic handling .
COURSE CONTENT: Topical areas of study include -
- Clean Manufacturing
- Changing work environment
- CGMPs
- Accountability
- SOPs
- Sources of contamination
- Documentation
- Gowning
- FDA
- Environmental monitoring
- SISPQ
- Cleaning procedures
- CIP/SIP
- Aseptic technique
- Product life cycle
- Cleanroom behaviors
- FDA History
- Basic metrology
- CFRs
- Six Sigma
- Reading for content
- Lean Manufacturing
- Training
Course Addendum - Syllabus (Click to expand)
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