Quality Assurance & Regulatory Affairs for the Biosciences
Quality Assurance & Regulatory Affairs for the Biosciences
Jack O'Grady
- 1 online resource
- Open textbook library. .
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 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.
In English.
Biology--Textbooks
Science--Textbooks
QH308.2 QH301
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 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.
In English.
Biology--Textbooks
Science--Textbooks
QH308.2 QH301