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Quality Management Systems for Drugs and Devices (e-book)

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Quality Management Systems for Drugs and Devices (e-book)

Table of Contents

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Lead Editors

Peter A. Takes, PhD, RAC, FRAPS

Product Description

Quality Management Systems for Drugs and Devices presents a comprehensive overview of quality management systems (QMS), with a focus on quality assurance, good manufacturing practice, good clinical practice, and good laboratory practice. Comprised of 28 chapters from 10 RAPS books, this e-book demonstrates the application of quality systems concepts throughout all aspects of product development and implementation. Key topics include laboratory testing, production, clinical studies, inspection, compliance, and enforcement. Quality Management Systems for Drugs and Devices will help readers quickly identify key quality systems elements applicable to their specific interest area.

Who should buy this book?

Regulatory professionals, regardless of role, need to understand the principles and practices of quality management systems (QMS). Elements of an effective quality system are integral to many functions, including general compliance, clinical affairs, manufacturing, and advertising/marketing. Quality Management Systems for Drugs and Devices is an excellent resource for quality managers at all levels, as well as for students of quality management.

Regulatory professionals, regardless of their role, need to acquire expertise and maintain up-to-date knowledge in the principles and practices of quality management systems.
Peter A. Takes, PhD, RAC, FRAPS

Published by RAPS © 2021. E-book. 432 pages. ISBN: 978-1-947493-75-9.

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