Regulated Bioanalytical Laboratories (ePub)
Technical and Regulatory Aspects from Global Perspectives
(Sprache: Englisch)
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...
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Produktinformationen zu „Regulated Bioanalytical Laboratories (ePub)“
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.
Autoren-Porträt von Michael Zhou
Michael Zhou, PhD, is Director of Bioanalytical Chemistry atSynta 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
Bibliographische Angaben
- Autor: Michael Zhou
- 2011, 1. Auflage, 560 Seiten, Englisch
- Verlag: John Wiley & Sons
- ISBN-10: 047092280X
- ISBN-13: 9780470922804
- Erscheinungsdatum: 31.03.2011
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eBook Informationen
- Dateiformat: ePub
- Größe: 2.83 MB
- Mit Kopierschutz
Sprache:
Englisch
Kopierschutz
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