Quality Assurance & Regulatory Affairs for the Biosciences Jack O'Grady

By: Contributor(s): Material type: TextSeries: Open textbook libraryDistributor: Minneapolis, MN Open Textbook LibraryPublisher: Austin, Texas Austin Community College [2019]Copyright date: ©2019Description: 1 online resourceContent type:
  • text
Media type:
  • computer
Carrier type:
  • online resource
Subject(s): LOC classification:
  • QH308.2
  • QH301
Online resources:
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
Subject: 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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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.

Attribution

In English.

Description based on online resource

Freely available e-book