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

Allport-Settle, Mindy J.

Softcover

ISBN 10: 0982147627 ISBN 13: 9780982147627

Verlag: PharmaLogika, 2010

Inhaltsangabe

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 The specific information in this manual is supplemented, not superseded, by other manuals and field guidance documents.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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Über die Autorin bzw. den Autor

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.

Details zur Ausgabe

• Verlag: PharmaLogika
• Erscheinungsdatum: 2010
• Sprache: Englisch
• ISBN 10: 0982147627
• ISBN 13: 9780982147627
• Einband: Taschenbuch
• Anzahl der Seiten: 800
• Kontakt zum Hersteller: Manufactured by Amazon on behalf of the author; https://www.amazon.de/hz/contact-us; ; c/o Amazon Media EU S.à.r.l., 38 Avenue John F. Kennedy; Luxembourg; L-1855; Luxemburg