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Michael Zhou

Regulated Bioanalytical Laboratories

★★★★★
★★★★★
€164.86
Title
A01=Michael Zhou
Author_Michael Zhou
bioanalytical operations
bioanalytical processes
bioanalytical regulatory perspectives
Bioanalytical technical perspectives
Category=MBGL
Category=PDN
Category=PNB
Category=PNF
eq_bestseller
eq_isMigrated=1
eq_nobargain
eq_non-fiction
eq_science
international bioanalytical regulations
laboratory audits
laboratory inspections
national bioanalytical regulations
strategies for bioanalytical methods

Product details

  • ISBN 9780470476598
  • Weight: 971g
  • Dimensions: 165 x 241mm
  • Publication Date: 21 Jan 2011
  • Publisher: John Wiley & Sons Inc
  • Publication City/Country: US
  • Product Form: Hardback
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Description
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.
About Michael Zhou

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