Quality Assurance & Regulatory Affairs for the Biosciences

QualityAssuranceRegulatoryAffairs.pdf

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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.