Writing and Managing SOPs for GCP - Couverture rigide

Prokscha, Susanne

Couverture rigide

ISBN 10 : 1482239353 ISBN 13 : 9781482239355

Editeur : CRC Press, 2015

Synopsis

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.

A propos du livre

À propos de l?auteur

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.

Détails de l'édition

• Éditeur: CRC Press
• Date d'édition: 2015
• Langue: anglais
• ISBN 10: 1482239353
• ISBN 13: 9781482239355
• Reliure: Relié
• Numéro d'édition: 1
• Nombre de pages: 206
• Coordonnées du fabricant: non disponible
• Personne responsable: gpsr@libri.de; gpsr@libri.de; ; Friedensallee 273; Hamburg; 22763; Allemagne