Product details | RAP


By Peter A. Takes, PhD, RAC, FRAPS


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

Written by dozens of global quality management system experts, this easy-to-use e-book presents the information needed to continually assess processes to improve business operations, increase efficiency, and ensure compliance with standards and regulations. Quality management systems for medicines and devices provides key considerations for successfully defining, planning and implementing a quality management system in your organization. This QMS e-book encompasses the diversity of expertise needed to address QS for the various applications in the development of medical and pharmaceutical devices.

Who should buy this book?

Regulatory professionals, whatever their role, should understand the principles and practices of quality management systems (QMS). The elements of an effective quality system are integral to many functions, including general compliance, clinical affairs, manufacturing, and advertising/marketing. Quality management systems for medicines and devices is an excellent resource for quality managers at all levels, as well as quality management students.

Discover RAPS Regipedia – a growing collection of over 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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