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    Quality Assurance & Regulatory Affairs for the Biosciences

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    Jack O'Grady, Austin Community College

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    Publisher: Austin Community College

    Language: English

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    CC BY

    Table of Contents

    • 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

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    About the Book

    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. 

    About the Contributors

    Author

    Dr. Jack O’Grady, Austin Community College, Biotechnology Program

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