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A Laboratory Quality Handbook of Best Practices and Relevant Regulations

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Title: A Laboratory Quality Handbook of Best Practices and Relevant Regulations
Author: Donald C. Singer
ISBN: 087389491X / 9780873894913
Format: Hard Cover
Pages: 404
Publisher: ASQ
Year: 2001
Availability: Out of Stock
     
 
  • Description
  • Contents

Based on the work of a collection of experts from the laboratory science and quality assurance fields, A Laboratory Quality Handbook of Best Practices and Relevant Regulations provides all of the information needed to run a successful laboratory that is in compliance with all regulations. From sample tracking to accurate documentation, training to methods validation, maintenance to calibration, and out-of-spec responses to preparation for audits, a combination of people, instrumentation and documentation must work in sync for high quality results. This handbook provides information that will help a laboratory achieve high quality results and compliance.


Preface
Acknowledgements

PART 1 : QUALITY IN THE LABORATORY
Chapter 1 : Quality Assurance in the Laboratory
Chapter 2 : History of Regulation and the Laboratory
Chapter 3 : An Overview of Key Parameters for Evaluating a Laboratory

PART 2 : CRITICAL LABORATORY OPERATIONS
Chapter 4 : Training in the Laboratory
Chapter 5 : Laboratory Documentation and Data
Chapter 6 : Sample Control and LIM Systems
Chapter 7 : Laboratory Equipment Qualification
Chapter 8 : Equipment Calibration and Maintenance
Chapter 9 : Laboratory Water and Water Purification Systems
Chapter 10 : Methods Validation
Chapter 11 : Out of Specification Results

PART 3 : INSPECTIONS
Chapter 12 : An FDA Approach to Laboratory Inspections

PART 4 : Additional Appendices
Chapter 13 : Accreditation and Harmonization

Index

 
 
 
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