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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)
By Peter A. Takes, PhD, RAC, FRAPS


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.

Written by dozens of global QMS experts, this easy-to-use e-book presents information necessary to continually evaluate processes to improve business operations, increase efficiency, and ensure compliance with standards and regulations. Quality Management Systems for Drugs and Devices provides key considerations to successfully define, plan, and implement a quality management system in your organization. This QMS e-book encompasses the diversity of expertise necessary to address QS for the various applications within medical device and pharmaceutical development.

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.

Check out RAPS Regipedia - a growing collection of more than 2,300 regulatory terms, definitions and acronyms developed exclusively for RAPS members.

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