Basic Method Validation and Verification, 4th Edition PDF Download

Author: James O. Westgard
Publisher:
ISBN: 9781886958333
Category :
Languages : en
Pages : 308

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Author: James O. Westgard
Publisher:
ISBN:
Category : Medical
Languages : en
Pages : 268

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Book Description

Author: Chung Chow Chan
Publisher: John Wiley & Sons
ISBN: 047146371X
Category : Science
Languages : en
Pages : 320

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Book Description
Validation describes the procedures used to analyze pharmaceutical products so that the data generated will comply with the requirements of regulatory bodies of the US, Canada, Europe and Japan. Calibration of Instruments describes the process of fixing, checking or correcting the graduations of instruments so that they comply with those regulatory bodies. This book provides a thorough explanation of both the fundamental and practical aspects of biopharmaceutical and bioanalytical methods validation. It teaches the proper procedures for using the tools and analysis methods in a regulated lab setting. Readers will learn the appropriate procedures for calibration of laboratory instrumentation and validation of analytical methods of analysis. These procedures must be executed properly in all regulated laboratories, including pharmaceutical and biopharmaceutical laboratories, clinical testing laboratories (hospitals, medical offices) and in food and cosmetic testing laboratories.

Author: James O. Westgard
Publisher: Westgard Quality Corporation
ISBN: 9781886958258
Category : Medical
Languages : en
Pages : 320

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Author: Hugh W. Coleman
Publisher: John Wiley & Sons
ISBN: 1119417708
Category : Technology & Engineering
Languages : en
Pages : 420

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Book Description
Helps engineers and scientists assess and manage uncertainty at all stages of experimentation and validation of simulations Fully updated from its previous edition, Experimentation, Validation, and Uncertainty Analysis for Engineers, Fourth Edition includes expanded coverage and new examples of applying the Monte Carlo Method (MCM) in performing uncertainty analyses. Presenting the current, internationally accepted methodology from ISO, ANSI, and ASME standards for propagating uncertainties using both the MCM and the Taylor Series Method (TSM), it provides a logical approach to experimentation and validation through the application of uncertainty analysis in the planning, design, construction, debugging, execution, data analysis, and reporting phases of experimental and validation programs. It also illustrates how to use a spreadsheet approach to apply the MCM and the TSM, based on the authors’ experience in applying uncertainty analysis in complex, large-scale testing of real engineering systems. Experimentation, Validation, and Uncertainty Analysis for Engineers, Fourth Edition includes examples throughout, contains end of chapter problems, and is accompanied by the authors’ website www.uncertainty-analysis.com. Guides readers through all aspects of experimentation, validation, and uncertainty analysis Emphasizes the use of the Monte Carlo Method in performing uncertainty analysis Includes complete new examples throughout Features workable problems at the end of chapters Experimentation, Validation, and Uncertainty Analysis for Engineers, Fourth Edition is an ideal text and guide for researchers, engineers, and graduate and senior undergraduate students in engineering and science disciplines. Knowledge of the material in this Fourth Edition is a must for those involved in executing or managing experimental programs or validating models and simulations.

Author: United States. Food and Drug Administration. Division of Microbiology
Publisher:
ISBN:
Category : Microbiology
Languages : en
Pages : 180

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Book Description

Author: John V. Crable
Publisher:
ISBN:
Category : Analytical chemistry
Languages : en
Pages : 816

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Book Description

Author: Sharon S. Ehrmeyer
Publisher:
ISBN: 9781886958357
Category :
Languages : en
Pages : 276

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Author:
Publisher: John Wiley & Sons
ISBN: 1555818811
Category : Medical
Languages : en
Pages : 2954

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Book Description
In response to the ever-changing needs and responsibilities of the clinical microbiology field, Clinical Microbiology Procedures Handbook, Fourth Edition has been extensively reviewed and updated to present the most prominent procedures in use today. The Clinical Microbiology Procedures Handbook provides step-by-step protocols and descriptions that allow clinical microbiologists and laboratory staff personnel to confidently and accurately perform all analyses, including appropriate quality control recommendations, from the receipt of the specimen through processing, testing, interpretation, presentation of the final report, and subsequent consultation.

Author: Joachim Ermer
Publisher: John Wiley & Sons
ISBN: 3527604472
Category : Science
Languages : en
Pages : 418

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Book Description
Adopting a practical approach, the authors provide a detailed interpretation of the existing regulations (GMP, ICH), while also discussing the appropriate calculations, parameters and tests. The book thus allows readers to validate the analysis of pharmaceutical compounds while complying with both the regulations as well as the industry demands for robustness and cost effectiveness. Following an introduction to the basic parameters and tests in pharmaceutical validation, including specificity, linearity, range, precision, accuracy, detection and quantitation limits, the text focuses on a life-cycle approach to validation and the integration of validation into the whole analytical quality assurance system. The whole is rounded off with a look at future trends. With its first-hand knowledge of the industry as well as regulating bodies, this is an invaluable reference for analytical chemists, the pharmaceutical industry, pharmaceutists, QA officers, and public authorities.