Quality Assurance & Regulatory Affairs for the Biosciences

• 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.