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URL :  Quality Assurance & Regulatory Affairs for the Biosciences
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Author : Jack O'Grady
Detail : 2020 | PDF | 1.3 Mb | 141 pages

eBook License: Creative Commons Attribution 4.0 International License

What is Biotechnology? According to the United Nations Convention on Biological Diversity, biotechnology is “any technological application that uses biological systems, living organisms, or derivatives thereof, to make or modify products or processes for a specific use."
The concept of “specific use” typically involves a commercial application or benefit to humanity. Genetic engineering, artificial selection, antibiotic production, and cell culture are current topics of study in biotechnology. However, humans were using microbes to create useful products long before Karl Ereky, a Hungarian engineer, coined the term biotechnology. (From Author)

eBook Contents

Introduction to Biotechnology & Quality Assurance - Introduction to Quality Principles - Quality Management Systems - The Food & Drug Administration - Good Guidance Practices (GXPs) - The Drug Approval Process - The Regulation of Biologics - Medical Device & Combination Products - Regulation of Food & Other Products – FDA Enforcement
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