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Regulated Bioanalytical Laboratories:

Technical and Regulatory Aspects from Global Perspectives (Google eBook)
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John Wiley & Sons, Mar 31, 2011 - Science - 528 pages
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.
  

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Parts of the History chapter are identical with this article
http://www.biopharminternational.com/biopharm/article/articleDetail.jsp?id=73842
which says it was published in 2003 and is by a
different author. One of these sources plagiarized the other, or the author has changed his name. Weird.  

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Contents

IV
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V
8
VI
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VII
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VIII
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IX
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X
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XI
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XXXVIII
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XXXIX
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XL
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XLI
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XIV
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XXXI
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XXXIV
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LXV
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LXVI
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LXVII
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LXVIII
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LXIX
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LXX
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LXXI
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About the author (2011)

Michael Zhou, PhD, is Director of Bioanalytical Chemistry at Synta Pharmaceuticals Corporation and a highly regarded expert on analytical/bioanalytical operations, regulatory compliance, including Good Laboratory Practice (GLP), cGMP, GCP regulations, and ICH, GCLP, BMV guidelines. Dr. Zhou has given numerous presentations and workshops / short courses on the topics at national and international conferences and has authored over fifty research articles and two book chapters on analytical/bioanalytical chemistry

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