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BIOT 117: Quality Control Techniques
3.00 Credits
Ivy Tech Community College
Students will be introduced to those principles associated with quality control from a life sciences perspective. Students will learn about common microbial contaminants and how to prevent them. Students will also gain experience with common monitoring techniques used in the biotech industry.
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BIOT 117 - Quality Control Techniques
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BIOT 172: Survey of Regulatory Affairs
3.00 Credits
Ivy Tech Community College
This course provides an entry level introduction to the laws and regulations that govern the development, marketing and commercial distribution of drugs, biological and medical device products and how they relate to the pharmaceutical, biotechnology and medical device industry. This course in intended to provide individuals with a greater understanding of regulatory affairs, specifically providing an understanding of how their actions are controlled by regulations and how to interact with FDA or global regulatory agencies.
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BIOT 172 - Survey of Regulatory Affairs
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BIOT 199: Biotechnology Elective
1.00 - 6.00 Credits
Ivy Tech Community College
No course description available.
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BIOT 199 - Biotechnology Elective
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BIOT 201: Cell Culture and Cellular Processes
4.00 Credits
Ivy Tech Community College
The student will be introduced to major biochemical pathways, cellular structure and function at a molecular level. Topics to be considered include the structure and function of the cell membrane, cytoskeleton and various organelles. Cellular respiration will be discussed. Protein synthesis, processing and export will be examined. Those processes involved in cell division will also be investigated and related to cancer. The laboratory will center upon techniques involving animal, plant, fungi and bacterial cell cultures. Students will be taught how to isolate, culture and preserve prokaryotic organisms. Students will be taught how to maintain and preserve eukaryotic cell cultures. Students will learn to procure cell cultures from ATCC and other repositories.
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BIOT 201 - Cell Culture and Cellular Processes
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BIOT 211: Analytic Methods in Biotechnology I
3.00 Credits
Ivy Tech Community College
Students will become familiar with the theory and application of many analytical methods currently utilized in the field of biotechnology. These methods will include: ELISA and immunoaffinity techniques; methods for determining enzymatic activity; spectrophotometric methods; chromatographic methods; electrophoresis; light and electron microscopy. When feasible, techniques will be practiced in the laboratory setting. Methods utilizing radioactive isotopes will be discussed. Considerable emphasis will be placed on proper methods for data recording, analysis and presentation.
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BIOT 211 - Analytic Methods in Biotechnology I
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BIOT 212: Analytic Methods in Biotechnology II
3.00 Credits
Ivy Tech Community College
Students will continue their study of the theory and application of many analytical methods currently utilized in the field of biotechnology. These methods will include: centrifugation, light and electron microscopy, restriction endonuclease digestion, agar and acrylamide electrophoresis of nucleic acids, Southern and Northern blotting, polymerase chain reaction and bioassays. When feasible, techniques will be practiced in the laboratory setting. Methods utilizing radioactive isotopes will be discussed. Considerable emphasis will be placed on proper methods for data recording, analysis and presentation.
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BIOT 212 - Analytic Methods in Biotechnology II
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BIOT 214: Food and Drug Law
3.00 Credits
Ivy Tech Community College
This course provides a basic introduction to the laws and regulations that govern the development, marketing and commercial distribution of drugs, biological and medical device products and how they relate to the pharmaceutical, biotechnology and medical devices industry. This course is designed to provide students with an overall landscape of U.S. and International laws regulating the drug, biotechnology and medical device industry.
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BIOT 214 - Food and Drug Law
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BIOT 215: Clinical Trials
3.00 Credits
Ivy Tech Community College
This course provides a basic introduction to clinical trials, including their design, how they are conducted, and concepts of current good clinical practices (cGCPs). This course is designed to provide students with an overall landscape of the clinical trial process, FDA regulations and ICH guidelines pertaining to that process.
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BIOT 216: Risk Management for Drugs and Medical Devices
3.00 Credits
Ivy Tech Community College
This course provides a basic introduction to risk management strategy application of best practices and risk management for both the drug and medical device industry. This course is designed to provide students with an overall understanding of this growing discipline to improve patient safety and the regulatory mandates and laws.
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BIOT 216 - Risk Management for Drugs and Medical Devices
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BIOT 217: Biotechnology Manufacturing Processes
3.00 Credits
Ivy Tech Community College
Student will be introduced to the processes and procedures involved in the manufacture of biological molecules on both large- and small-scales. The student will learn the function of commonly used manufacturing equipment associated with biotechnology and understand the cGMP¿s associated with the use of such equipment. The regulatory environment associated with most biotechnology endeavors will be reviewed including those mandated by FDA, USDA and OSHA.
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BIOT 217 - Biotechnology Manufacturing Processes
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