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Regulated Bioanalytical Laboratories: Technical and Regulatory Aspects from Global Perspectives
Michael Zhou
€ 166.53
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Description for Regulated Bioanalytical Laboratories: Technical and Regulatory Aspects from Global Perspectives
Hardcover. Developing and implementing strategies for routine, non-routine, and standard bioanalytical methods and on the entire equipment hardware and software qualification process, is the topic of this book. It includes guidelines on qualification of certified standards and in-house reference material as well as on people qualification. Num Pages: 526 pages, Illustrations. BIC Classification: MBGL; PDN; PNF. Category: (P) Professional & Vocational. Dimension: 240 x 150 x 34. Weight in Grams: 978.
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 ... Read more
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 ... Read more
Product Details
Format
Hardback
Publication date
2011
Publisher
John Wiley & Sons Inc United Kingdom
Number of pages
526
Condition
New
Number of Pages
560
Place of Publication
New York, United States
ISBN
9780470476598
SKU
V9780470476598
Shipping Time
Usually ships in 7 to 11 working days
Ref
99-50
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 ... Read more
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