Susanne Prokscha

Writing and Managing SOPs for GCP (eBook, ePUB)

• Format: ePub

Produktbeschreibung

This book discusses managing SOPs for GCP from conception to retirement. It recommends approaches that have a direct impact on improving SOP and regulatory compliance. Throughout the text, the book provides a user's point of view to keep topics focused on the practical aspects of SOPs and SOP management.

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Produktdetails

• Verlag: Taylor & Francis
• Erscheinungstermin: 29. Juli 2015
• Englisch
• ISBN-13: 9781040071007
• Artikelnr.: 72251747

Autorenporträt

Susanne Prokscha is a director in clinical data management for process and training at Onyx Pharmaceuticals in San Francisco, California. She has been involved in clinical data management (CDM) processes and technologies since the mid-1980s. Ms. Prokscha has worked both as a consultant and directly for large and small companies, gaining experience with a wide range of studies and a variety of clinical data management systems. Her interest in advancing the field of CDM and helping emerging CDM groups led her to write Practical Guide to Clinical Data Management. She currently focuses on process development, SOP writing, document management, and training for CDM and Biometrics groups.