Quality Assurance and Regulatory Affairs for the Biosciences
- Page ID
- 39469
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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