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Laboratory Quality Handbook of Best Practices and Relevant Regulations.

Detalles Bibliográficos
Clasificación:Libro Electrónico
Autor principal: Singer, Donald C.
Formato: Electrónico eBook
Idioma:Inglés
Publicado: Milwaukee : ASQ Quality Press, 2000.
Temas:
Acceso en línea:Texto completo

MARC

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245 1 0 |a Laboratory Quality Handbook of Best Practices and Relevant Regulations. 
260 |a Milwaukee :  |b ASQ Quality Press,  |c 2000. 
300 |a 1 online resource (387 pages) 
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505 0 |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. 
505 8 |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. 
505 8 |a Appendix G FDA Good Laboratory Practices for Nonclinical Lab Studies -- Bibliography -- Index. 
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650 0 |a Laboratories  |x Law and legislation  |v Handbooks, manuals, etc. 
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