Writing and Managing SOPs for GCP - Softcover

Prokscha, Susanne

 
9781032926735: Writing and Managing SOPs for GCP
Softcover
ISBN 10: 1032926732 ISBN 13: 9781032926735
Verlag: CRC Press, 2024

Inhaltsangabe

Writing and Managing SOPs for GCP is the first book to discuss managing Standard Operating Procedures (SOPs) for Good Clinical Practice (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.

The idea of specifically calling out approaches to SOP creation and maintenance in an effort to make it easier for users to stay in compliance is a theme found throughout all book chapters. Examples in each chapter provide accurate reflections of real-world experiences to illustrate the discussion. The book also includes an example "SOP of SOPs" along with an associated SOP template.

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Über die Autorin bzw. den Autor

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.

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Verlag
CRC Press
Erscheinungsdatum
2024
Sprache
Englisch
ISBN 10 
1032926732
ISBN 13 
9781032926735
Einband
Taschenbuch
Anzahl der Seiten
224
Kontakt zum Hersteller
Taylor & Francis Verlag GmbH
GPSR@taylorandfrancis.com

Kaufingerstraße 24
München
80331
Deutschland

Weitere beliebte Ausgaben desselben Titels

9781482239355: Writing and Managing SOPs for GCP

Vorgestellte Ausgabe

ISBN 10:  1482239353 ISBN 13:  9781482239355
Verlag: CRC Press, 2015
Hardcover