Quality Assurance & 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. Individual chapter titles are:
- Chapter 1: Introduction to Biotechnology & Quality Assurance
- Chapter 2: Introduction to Quality Principles
- Chapter 3: Quality Management Systems
- Chapter 4: The Food & Drug Administration
- Chapter 5: Good Guidance Practices (GXPs)
- Chapter 6: The Drug Approval Process
- Chapter 7: The Regulation of Biologics
- Chapter 8: Medical Device & Combination Products
- Chapter 9: Regulation of Food & Other Products
- Chapter 10: FDA Enforcement
This text book includes explanatory text, definitions, diagrams, case studies, and links to additional resources. Each chapter opens with a list of stated learning objectives.
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