Current Good Manufacturing Practices: Pharmaceutical, Biologics, and Medical Device Regulations and Guidance Documents Concise Reference

by Mindy J. Allport-settle

Overview

FDA Regulations and Associated Guidance Documents:
- Part 11 Electronic Records; Electronic Signatures
- Part 26 Mutual Recognition of Pharmaceutical Good Manufacturing Practice Reports, Medical Device Quality System Audit Reports, and Certain Medical Device Product Evaluation Reports: United States and the European Community
- Part 200 Drugs General
- Part 207 Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution
- Part 210 Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs
- Part 211 Current Good Manufacturing Practice For Finished Pharmaceuticals
- Part 600 Biological Products: General
- Part 807 Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices
- Part 820 Quality System Regulation

Reference Tools:

- Glossaries combined in one location
- GMP Keyword Index for 21CFR211
- Combined Index for all documents

Product Details

BN ID:	2940011837326
Publisher:	PharmaLogika
Publication date:	09/17/2009
Sold by:	Barnes & Noble
Format:	eBook
Pages:	634
File size:	844 KB

About the Author

Following in the footsteps of Gordon Allport, all of Mindy J. Allport-Settle's books are built on a foundation of psychology and sociology with a focus on improving some aspect of industry through research and education. Her career in healthcare began when she was a teenager working as an emergency medical technician. Since then, she has joined the U.S. Navy's advanced hospital corps, worked in organ and human tissue procurement, specialized in ophthalmology, and moved on to serve as a key executive, board member, and consultant for some of the best companies in the pharmaceutical, medical device, and biotechnology industry. She has provided guidance in regulatory compliance, corporate structuring, restructuring and turnarounds, new drug submissions, research and development and product commercialization strategies, and new business development. Her experience and dedication have resulted in international recognition as the developer of the only FDA-recognized and benchmarked quality systems training and development business methodology. Her education includes a Bachelor's degree from the University of North Carolina, an MBA in Global Management from the University of Phoenix, and completion of the corporate governance course series in audit committees, compensation committees, and board effectiveness at Harvard Business School.