Practical Approaches to Method Validation and Essential Instrument Qualification -

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Résumé :
All regulated laboratories, including pharmaceutical, clinical testing, food and cosmetic laboratories, must properly execute the calibration of instruments and validation of analytical methods. Advance Technologies in Instrumentation, Qualification, Performance, Verification and Analytical Methods Validation skillfully explains important, but advanced, techniques of method validation and instrument performance. The book covers validation of methods for significant new or evolving procedures, such as proteomic assays, rapid microbial identification, and process analytical technologies, making this text a must-read for analysts, scientists, engineers, technologists, and technical managers.

Biographie:
CHUNG CHOW CHAN, PhD, is a Consultant for CCC Consulting, and the former president of the Calibration & Validation Group, a nonprofit organization dedicated to the art and science of instrument calibration and method validation. HERMAN LAM, PhD, is the Principal of Wild Crane Horizon and President of the Calibration & Validation Group. Dr. Lam has developed and presented an instrument qualification and performance verification course for Agilent Technologies and other organizations in North America and Asia. XUE MING ZHANG, PhD, is a Manager at Apotex, responsible for overseeing the development of stable liquid formulations. He also works on method development and validation for both instrument and chemical analysis.

Sommaire:
Chapter 1 Overview of Risk Based Approach to Phase Appropriate Validation and Instrument Qualification. Chapter 2 Phase Appropriate Method Validation. Chapter 3 Analytical Method Verification, Method Revalidation, and Method Transfer. Chapter 4 Validation of PAT Applications. Chapter 5 The Validation of Near Infrared Systems for Raw Material Identification. Chapter 6 Cleaning Validation. Chapter 7 Risk Based Validation of laboratory Information Management Systems (LIMS). Chapter 8 Performance Qualification and Verification of Balance. Chapter 9 Performance Verification of NIR Spectrophotometers. Chapter 10 Operational Qualification in Practice for Gas Chromatography Instruments. Chapter 11 Performance Verification on RI, Fluorescence, Evaporative Light Scattering Detection. Chapter 12 Instrument Qualification and Performance Verification for Particle Size Instruments. Chapter 13 Method Validation, Qualification, and Performance Verification for Total Organic Carbon (TOC) Analyzers. Chapter 14 Instrument Performance Verification - Micro Pipettes. Chapter 15 Instrument Qualification and Performance Verification for Automated Liquid Handling Systems. Chapter 16 Performance Qualification and Verification in Powder X-ray Diffraction.