Good Manufacturing Practice (GMP) Guidelines: The Rules Governing Medicinal Products in the European Union, EudraLex Volume 4 Concise Reference

Mindy J Allport-Settle

ISBN 10: 0982147600 / ISBN 13: 9780982147603

Published by Pharmalogika, 2009

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Bibliographic Details

• Title: Good Manufacturing Practice (GMP) Guidelines: The Rules Governing Medicinal Products in the European Union, EudraLex Volume 4 Concise Reference
• Publisher: Pharmalogika
• Publication Date: 2009
• Language: English
• ISBN 10: 0982147600
• ISBN 13: 9780982147603
• Binding: Paperback / softback
• Condition: New
• Weight: 933 grams

About this title

Synopsis

This title combines all of the human and veterinary Regulations, Directives and guidance for medicinal products used by the pharmaceutical industry as their main source when manufacturing and distributing medicinal products in the European Union.

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, medical device, and biotechnology industry. She has provided 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. 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.