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

Allport-Settle, Mindy J.

Softcover

ISBN 10: 1449505236 ISBN 13: 9781449505233

Publisher: CreateSpace Independent Publishing Platform, 2009

Synopsis

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

About this title

About the Author

Mindy Allport-Settle has served as a key executive, board member, and consultant for some of the best companies in the pharmaceutical and FDA-regulated industry. Since joining PharmaLogika as CEO in 2008 and over her career, she has provided informed guidance in regulatory compliance, corporate structuring, restructuring and turnarounds, new drug submissions, research & development and product commercialization strategies, operational, project and contract management, 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 designed for regulated industries. 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.

Edition details

• Publisher: CreateSpace Independent Publishing Platform
• Publication date: 2009
• ISBN 10: 1449505236
• ISBN 13: 9781449505233
• Binding: Paperback
• Language: English
• Number of pages: 634