A Practical Guide to Quality Management in Clinical Trial Research
A Matter-of-fact Guide to Quality Management in Clinical Trial Research Books
Product 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 trying and time-consuming exercise. Examining how to maintain quality control in clinical trial research, A Matter-of-fact Guide to Quality Management in Clinical Trial Research provides a cornerstone of knowledge for establishing a quality system that complies with the relevant set of laws. There are many books available that cover how to interpret set of laws. Going a step or two further, this book provides matter-of-fact advice that is helpful on a daily basis.
The book contains in rank 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 makes 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 set of laws. The author’s integrated approach and anecdotal style turns technically right in rank into simple reading. The book arms you with tools and concepts that you can use to go beyond regulatory compliance and go into the realm of business quality improvement.
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