A Practical Guide to Quality Management in Clinical Trial Research by Graham Ogg

Description: A Practical Guide to Quality Management in Clinical Trial Research by Graham Ogg A Practical Guide to Quality Management in Clinical Trial Research FORMAT Hardcover LANGUAGE English CONDITION Brand New Publisher Description Setting up a GXP environment where none existed previously is a very daunting task. Getting staff to write down what they do for every task is a correspondingly difficult and time-consuming exercise. Examining how to maintain quality control in clinical trial research, A Practical Guide to Quality Management in Clinical Trial Research provides a cornerstone of knowledge for establishing a quality system that complies with the relevant regulations. There are many books available that cover how to interpret regulations. Going a step or two further, this book provides practical advice that is useful on a daily basis.The book contains information for various standards including GLPs, GCPs, and GMPs. It gives detailed explanations of how to prepare, update, and maintain SOPs and includes advice on training and development of personnel. Drawing directly on his years of experience, the author delineates a from-the-trenches methodology that creates a value-added quality management system from a business perspective. He provides a solid foundation as well as tips and techniques for establishing a quality system that will comply with all the relevant regulations. The authors integrated approach and anecdotal style turns technically accurate information into easy reading. The book arms you with tools and concepts that you can use to go beyond regulatory compliance and move into the realm of business quality improvement. Author Biography Graham Ogg Table of Contents In the Beginning There Was GLP. Before GCP. Training in the Regulated Environment. Computing in the Regulated Environment. QA Activity. Beyond Compliance. Business Improvement. A Summary. Appendix: Information Resources and Acronyms. Review "…provides the reader with a pragmatic approach to the principles governing accepted methodologies within the working environment and provides some useful examples of these interpretational differences across industry."-Quasar"…provides a solid foundation as well as tips and techniques for establishing a quality system that will comply with all the relevant regulations."--Anticancer Research Details ISBN0849397227 Short Title PRAC GT QUALITY MGMT IN CLINIC Language English ISBN-10 0849397227 ISBN-13 9780849397226 Media Book Format Hardcover Year 2005 Author Graham Ogg Edition 1st Country of Publication United States DEWEY 615.50724 Affiliation Drug Development Solutions Ltd., Dundee, Scotland, UK DOI 10.1604/9780849397226 UK Release Date 2005-11-01 AU Release Date 2005-11-01 NZ Release Date 2005-11-01 US Release Date 2005-11-01 Imprint CRC Press Inc Place of Publication Bosa Roca Pages 228 Publisher Taylor & Francis Inc Publication Date 2005-11-01 Illustrations 14 Tables, black and white; 5 Illustrations, black and white Audience Professional & Vocational We've got this At The Nile, if you're looking for it, we've got it. With fast shipping, low prices, friendly service and well over a million items - you're bound to find what you want, at a price you'll love! TheNile_Item_ID:158179246;

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