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OverviewSetting 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 author's 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. Full Product DetailsAuthor: Graham Ogg (Drug Development Solutions Ltd., Dundee, Scotland, UK)Publisher: Taylor & Francis Inc Imprint: CRC Press Inc Dimensions: Width: 15.60cm , Height: 1.80cm , Length: 23.40cm Weight: 1.050kg ISBN: 9780849397226ISBN 10: 0849397227 Pages: 228 Publication Date: 01 November 2005 Audience: Professional and scholarly , Professional & Vocational Format: Hardback Publisher's Status: Active Availability: In Print This item will be ordered in for you from one of our suppliers. Upon receipt, we will promptly dispatch it out to you. For in store availability, please contact us. Table of ContentsReviews...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 Author InformationGraham Ogg Tab Content 6Author Website:Countries AvailableAll regions |