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Synopsis
Documentation Basics that Support Good Manufacturing Practices is a clear, concise guide to establishing a documentation system for validation of equipment, utilities, analytical methods and processes in a medical manufacturing enviromment . Author and independent consultant Carol DeSain leads the reader through the steps necessary to establish a documentation system meeting GMP requirements -- turning what is often an overwhelming task into a straightforward procedure.
Using sample documents and simple, step-by-step instructions, DeSain demonstrates how to track any method or process, from master batch production to equipment validation, maintenance and repair. She shows how to set in place a standardized, company-wide documentaiton system that will serve to validate any manufacturing process; how to create Standard Operating Procedures that are truly informative; and how to write and design documents that communicate effectively.
Professionals outside the medical manufacturing industry will also find that the validation system presented in Documentation Basics is easily adapted to any business or industrial environment.
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About the Author
Author and independent consultant Carol DeSain has 29 years' experience in product development, manufacturing and quality control and specific expertise in the design and implementation of QA documentation systems. In Documentation Basics she uses simple, step-by-step instructions and sample documents to show how to validate any method or process to met GMP and other regulatory requirements.
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