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Zhou, Michael

Regulated Bioanalytical Laboratories: Technical and Regulatory Aspects from Global Perspectives

Zhou, Michael - Regulated Bioanalytical Laboratories: Technical and Regulatory Aspects from Global Perspectives, ebook

149,50€

Ebook, ePUB with Adobe DRM
ISBN: 9780470922804
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This book provides useful information for bioanalytical / analytical scientists, analysts, quality assurance managers, and all personnel in bioanalytical laboratories through all aspects of bioanalytical technical and regulatory perspectives within bioanalytical operations and processes. Readers learn how to develop and implement strategies for routine, non-routine, and standard bioanalytical methods and on the entire equipment hardware and software qualification process. The book also gives guidelines on qualification of certified standards and in-house reference material as well as on people qualification. Finally, it guides readers through stressless internal and third party laboratory audits and inspections. It takes account to most national and international regulations and quality and accreditation standards, along with corresponding interpretation and inspection guides. The author elaborates on highly comprehensive content, making it easy not only to learn the subject but also to quickly implement the recommendations.

Keywords: Bioanalytical technical perspectives, bioanalytical regulatory perspectives, bioanalytical operations, bioanalytical processes, strategies for bioanalytical methods, laboratory audits, laboratory inspections, national bioanalytical regulations, international bioanalytical regulations, Drug Discovery & Development, Drug Discovery & Development

Author(s)
Publisher
John Wiley and Sons, Inc.
Publication year
2011
Language
en
Edition
1
Page amount
528 pages
Category
Natural Sciences
Format
Ebook
eISBN (ePUB)
9780470922804
Printed ISBN
9780470476598

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