Investigations Operations Manual: FDA Field Inspection and Investigation Policy and Procedure Concise Reference - Couverture souple

Allport-Settle, Mindy J.

 
9780982147627: Investigations Operations Manual: FDA Field Inspection and Investigation Policy and Procedure Concise Reference
Couverture souple
ISBN 10 : 0982147627 ISBN 13 : 9780982147627
Editeur : PharmaLogika, 2010

Synopsis

The IOM is the primary guidance document on FDA inspection policy and procedures for field investigators and inspectors. This extends to all individuals who perform field investigational activities in support of the Agency's public mission. Accordingly, it directs the conduct of all fundamental field investigational activities. Adherence to this manual is paramount to assure quality, consistency, and efficiency in field operations. The specific information in this manual is supplemented, not superseded, by other manuals and field guidance documents. The IOM is recommended reading for all operations regulated by the Food and Drug Administration.

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À propos de l?auteur

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 and 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.

Les informations fournies dans la section « A propos du livre » peuvent faire référence à une autre édition de ce titre.

Éditeur
PharmaLogika
Date d'édition
2010
Langue
anglais
ISBN 10 
0982147627
ISBN 13 
9780982147627
Reliure
Broché
Nombre de pages
800
Coordonnées du fabricant
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