Writing and Managing SOPs for GCP
Language: English
Published by Taylor and Francis Inc, US, 2015
- Hardcover
- New
Seller: Rarewaves.com UK, London, United KingdomRarewaves.com UK
AbeBooks seller since June 11, 2025
Condition: New
£ 285.94
Quantity: Over 20 available
Add to basketItem description from seller
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.
Seller Inventory # LU-9781482239355
- Title
- Writing and Managing SOPs for GCP
- Author
- Susanne Prokscha
- Publisher
- Taylor and Francis Inc, US
- Publication year
- 2015
- Condition
- New
- Binding
- Hardback
- Language
- English
- ISBN 10
- 1482239353
- ISBN 13
- 9781482239355
- Item weight
- 430 grams
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.
"Synopsis" may belong to another edition of this title.
About the Author
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.
"About the title" may belong to another edition of this title.
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