Donald C. Singer, Raluca-Ioana Stefan, Jacobus F. van Staden

Laboratory Auditing for Quality and Regulatory Compliance

• Gebundenes Buch

Produktbeschreibung

Identifying current tools, techniques, and approaches for the evaluation of laboratory operations, this reference reviews the latest regulatory standards and auditing practices to test laboratory safety, quality, and performance.

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Produktdetails

• Verlag: CRC Press
• Seitenzahl: 496
• Erscheinungstermin: 25. Juli 2005
• Englisch
• Abmessung: 235mm x 157mm x 31mm
• Gewicht: 864g
• ISBN-13: 9781574445701
• ISBN-10: 1574445707
• Artikelnr.: 21569980

Autorenporträt

Singer, Donald C.; Stefan, Raluca-Ioana; van Staden, Jacobus F.

Inhaltsangabe

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. Epiloge. 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. Bibliography