Franklin

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

Publication:
Austin, Texas Austin Community College [2019]
Format/Description:
Book
1 online resource
Series:
Open textbook library.
Distribution:
Minneapolis, MN Open Textbook Library
Status/Location:
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Details

Subjects:
Biology -- Textbooks.
Science -- Textbooks.
Language:
In English.
System Details:
data file
Summary:
This 125-page course textbook, entitled Quality Assurance and 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 and QUALITY ASSURANCE
CHAPTER 2: INTRODUCTION TO QUALITY PRINCIPLES
CHAPTER 3: QUALITY MANAGEMENT SYSTEMS
CHAPTER 4: THE FOOD and DRUG ADMINISTRATION
CHAPTER 5: GOOD GUIDANCE PRACTICES (GXPs)
CHAPTER 6: THE DRUG APPROVAL PROCESS
CHAPTER 7: THE REGULATION OF BIOLOGICS
CHAPTER 8: MEDICAL DEVICE and COMBINATION PRODUCTS
CHAPTER 9: REGULATION OF FOOD and OTHER PRODUCTS
CHAPTER 10: FDA ENFORCEMENT
Notes:
Description based on online resource
Contributor:
O'Grady, Jack author
Open Textbook Library distributor
Access Restriction:
Open Access Unrestricted online access star