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Quality Assurance & Regulatory Affairs for the Biosciences

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Jack O'Grady, Austin Community College

Copyright Year: 2019

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

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