Quality Assurance & Regulatory Affairs for the Biosciences
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.
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| Main Author: | |
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| Format: | Electronic eBook |
| Language: | English |
| Published: |
Austin, Texas
Austin Community College
[2019]
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| Series: | Open textbook library.
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| Subjects: | |
| Online Access: | Access online version |
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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