A Practical Guide to Quality Management in Clinical Trial Research
Publication Date December 2005
Publisher CRC Press
Product Type Book
Pages 200
ISBN Number 0849397227
Product Code CRC017
Examining how to maintain assured quality in clinical trial research, A Practical Guide to Quality Management in Clinical Trial Research provides solid foundations, tips, and techniques for establishing a quality system that will comply with the relevant regulations. This book offers useful information for various standards including Good Laboratory Practice, Good Clinical Practice, and Good Manufacturing Practice. It gives detailed explanations of how to prepare, update, and maintain Standard Operating Procedures and also includes advice on training and development of personnel. This text is ideal for clinical trial monitors and quality assurance personnel in the pharmaceutical industry.
Content
n 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.
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