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Regulated bioanalytical laboratories : technical and regulatory aspects from global perspectives

Author: Michael Zhou; Wiley InterScience (Online service)
Publisher: Hoboken, N.J. : Wiley, ©2011.
Edition/Format:   eBook : Document : EnglishView all editions and formats
Summary:
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  Read more...
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Genre/Form: Electronic books
Additional Physical Format: Print version:
Zhou, Michael.
Regulated bioanalytical laboratories.
Hoboken, N.J. : Wiley, ©2011
(DLC) 2010022398
(OCoLC)639940505
Material Type: Document, Internet resource
Document Type: Internet Resource, Computer File
All Authors / Contributors: Michael Zhou; Wiley InterScience (Online service)
ISBN: 9780470920671 047092067X 9780470920664 0470920661 1282889052 9781282889057
OCLC Number: 689994989
Description: 1 online resource (xix, 526 pages) : illustrations
Contents: Introduction, Objectives, and Key Requirements for GLP Regulations --
Historic Perspectives of GLP Regulations, Applicability, and Relation to Other Regulations --
GLP Quality System and Implementation --
Fundamental Elements and Structures for Regulated Bioanalytical Laboratories --
Technical and Regulatory Aspects of Bioanalytical Laboratories --
Competitiveness of Bioanalytical Laboratories--Technical and Regulatory Perspectives --
Sponsor and FDA/Regulatory Agency GLP Inspections and Study Audits --
Current Strategies and Future Trends --
General Terminologies of GxP and Bioanalytical Laboratories --
Appendix A: Generic Checklist for GLP/GXP Inspections/Audits --
Appendix B: General Template for SOP --
Appendix C: Typical SOPs for GLP/Regulated Bioanalytical Laboratory --
Appendix D: Basic Equipment/Apparatus for Bioanalytical Laboratory --
Appendix E: Website Linkages for Regulated Bioanalysis.
Responsibility: Michael Zhou.
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Abstract:

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.  Read more...

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