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|a 9780873894913
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|a 087389491X
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|a (OCoLC)923571299
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|a R852.L25 2001eb
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|a 616.07/56/0685
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|a UAMI
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|a Singer, Donald C.
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|a Laboratory Quality Handbook of Best Practices and Relevant Regulations.
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|a Milwaukee :
|b ASQ Quality Press,
|c 2000.
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300 |
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|a 1 online resource (387 pages)
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336 |
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|a text
|b txt
|2 rdacontent
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|a computer
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|a Print version record.
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|a Dedication -- Table of Contents -- Preface -- Acknowledgements -- I. Quality in the Laboratory -- 1 Quality Assurance in the Laboratory -- 2 History of Regulation and the Laboratory -- 3 An Overview of Key Parameters for Evaluating a Laboratory -- II. Critical Laboratory Operations -- 4 Training in the Laboratory -- 5 Laboratory Documentation and Data -- 6 Sample Control and LIM Systems -- Appendix A EPA Good Automated Laboratory Practices -- 7 Laboratory Equipment Qualification -- 8 Equipment Calibration and Maintenance -- 9 Laboratory Water and Water Purification Systems.
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|a 10 Methods Validation -- Appendix B ICH Guidelines on Validation of Analytical Procedures -- 11 Out-of-Specification Results -- III. Inspections -- 12 An FDA Approach to Laboratory Inspections -- Appendix D FDA Guide to Inspections of Pharmaceutical Quality Control Laboratories -- Appendix E FDA Guide to Inspections of Microbiological Quality Control Laboratories -- IV. An International Perspective -- 13 Accreditation and Harmonization -- Part V Additional Appendices -- Appendix F The OECD Principles of Good Laboratory Practice.
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|a Appendix G FDA Good Laboratory Practices for Nonclinical Lab Studies -- Bibliography -- Index.
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590 |
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|a ProQuest Ebook Central
|b Ebook Central Academic Complete
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650 |
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|a Laboratories
|x Quality control
|v Handbooks, manuals, etc.
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650 |
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|a Laboratories
|x Law and legislation
|v Handbooks, manuals, etc.
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650 |
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|a Laboratoires
|x Qualité
|x Contrôle
|v Guides, manuels, etc.
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650 |
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|a Laboratories
|x Law and legislation
|2 fast
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650 |
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|a Laboratories
|x Quality control
|2 fast
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655 |
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|a Handbooks and manuals
|2 fast
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|i has work:
|a Laboratory Quality Handbook of Best Practices and Relevant Regulations (Text)
|1 https://id.oclc.org/worldcat/entity/E39PCYb7rRhhjxhG9jDmhDTFdj
|4 https://id.oclc.org/worldcat/ontology/hasWork
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0 |
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|i Print version:
|a Singer, Donald C.
|t Laboratory Quality Handbook of Best Practices and Relevant Regulations.
|d Milwaukee : ASQ Quality Press, ©2000
|z 9780873894913
|
856 |
4 |
0 |
|u https://ebookcentral.uam.elogim.com/lib/uam-ebooks/detail.action?docID=3002514
|z Texto completo
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994 |
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|a 92
|b IZTAP
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