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Pharmaceutical Book from C.H.I.P.S.

Laboratory Auditing for Quality and Regulatory Compliance
by Donald Singer

Laboratory Auditing for Quality and Regulatory Compliance reviews the latest regulatory standards and auditing practices to test laboratory safety, quality, and performance.

Features:

  • Assists in the assessment of laboratory procedures in preparation for an external auditor
  • Reflects the impact of computers and information technologies on data generation, analysis, and storage
  • Offers a global perspective on laboratory management and quality control
  • Serves as a comprehensive guide to the design of an effective audit for enhanced laboratory operation

Contents

  • Introduction
  • Quality and Auditing
  • Quality Control and Quality Assurance in a Laboratory
  • The Regulated Industries
  • Goals of a Laboratory Quality Audit
  • Audit Tools : Observation, Working Knowledge and Audit Documents
  • Non-Technical Parameters for Evaluation. Quality Programs, Organizational Structure and Documentation
  • Personnel
  • Facility and Environment
  • Technical Parameters for Evaluation
  • Sample Control
  • Instrumentation
  • Automation of Analytical Process
  • Acquisition and Processing of Data
  • Uncertainty of Measurements
  • Reliability of Measurements
  • Standards and Standardisation
  • Supplies Organization
  • Proficiency Testing
  • Other Areas to Consider
  • Customer Satisfaction
  • Laboratory Health and Safety
  • Communications and Follow-Up
  • Closing Conference, Final Report, and Follow-Up
  • Frequency of Audit

Appendices

  • Sample Laboratory Quality Audit Document
  • National Voluntary Laboratory Accreditation Program, NIST Handbook 150
  • Guide To Quality In Analytical Chemistry (Eurachem/CITAC)
  • Quality Assurance of Research and Development and Non-routine Analysis (Eurachem/ CITAC)
  • Accreditation for Microbiological Laboratories (Eurachem/EA)
  • EPA Manual for Certification of Laboratories Analyzing Drinking Water
  • Federal Register (FDA): Good Laboratory Practice Regulations for Nonclinical Laboratory Studies

Index

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Laboratory Auditing for Quality and Regulatory Compliance
by Donald Singer
2005 496 pages $228.95 + shipping
Texas residents please add 6.75 % sales tax

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