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Quality assurance & regulatory affairs for the biosciences / Jack O'Grady.
- Format:
- Book
- Author/Creator:
- O'Grady, Jack, author.
- Language:
- English
- Subjects (All):
- Biology--Textbooks.
- Biology.
- Quality assurance--Textbooks.
- Quality assurance.
- Science--Textbooks.
- Science.
- Physical Description:
- 1 online resource
- Place of Publication:
- Austin, TX : Austin Community College ; [2019]
- Language Note:
- In English.
- Summary:
- 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.
- 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
- Notes:
- Description based on online resource
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