Quality Assurance and Regulatory Affairs for the Biosciences
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This 125-page course textbook, entitled Quality Assurance & Regulatory Affairs for the Biosciences, was created by Jack O'Grady, M.S., professor at Austin Community College. This textbook accompanies the course BITC 1340: Quality Assurance for the Biosciences.
Front Matter
1: Introduction to Biotechnology and Quality Assurance
2: Introduction to Quality Principles
3: Quality Management Systems
4: The Food and Drug Administration
5: Good Guidance Practices (GXPs)
6: The Drug Approval Process
7: The Regulation of Biologics
8: Medical Device and Combination Products
9: Regulation of Food and Other Products
10: FDA Enforcement
Back Matter