Basic Method Validation and Verification, 4th Edition PDF Download
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Author: James O. Westgard
Publisher:
ISBN: 9781886958333
Category :
Languages : en
Pages : 308
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Book Description
Author: James O. Westgard
Publisher:
ISBN: 9781886958333
Category :
Languages : en
Pages : 308
Get Book
Book Description
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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Book Description
Author: Tiziana Margaria
Publisher: Springer Nature
ISBN: 3031197593
Category : Computers
Languages : en
Pages : 483
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Book Description
This four-volume set LNCS 13701-13704 constitutes contributions of the associated events held at the 11th International Symposium on Leveraging Applications of Formal Methods, ISoLA 2022, which took place in Rhodes, Greece, in October/November 2022. The contributions in the four-volume set are organized according to the following topical sections: specify this - bridging gaps between program specification paradigms; x-by-construction meets runtime verification; verification and validation of concurrent and distributed heterogeneous systems; programming - what is next: the role of documentation; automated software re-engineering; DIME day; rigorous engineering of collective adaptive systems; formal methods meet machine learning; digital twin engineering; digital thread in smart manufacturing; formal methods for distributed computing in future railway systems; industrial day.
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.
Author: Paul H. King
Publisher: CRC Press
ISBN: 0429786050
Category : Medical
Languages : en
Pages : 725
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Book Description
This fourth edition is a substantial revision of a highly regarded text, intended for senior design capstone courses within departments of biomedical engineering, bioengineering, biological engineering and medical engineering, worldwide. Each chapter has been thoroughly updated and revised to reflect the latest developments. New material has been added on entrepreneurship, bioengineering design, clinical trials and CRISPR. Based upon feedback from prior users and reviews, additional and new examples and applications, such as 3D printing have been added to the text. Additional clinical applications were added to enhance the overall relevance of the material presented. Relevant FDA regulations and how they impact the designer’s work have been updated. Features Provides updated material as needed to each chapter Incorporates new examples and applications within each chapter Discusses new material related to entrepreneurship, clinical trials and CRISPR Relates critical new information pertaining to FDA regulations. Presents new material on "discovery" of projects "worth pursuing" and design for health care for low-resource environments Presents multiple case examples of entrepreneurship in this field Addresses multiple safety and ethical concerns for the design of medical devices and processes
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: J. N. Reddy
Publisher: Cambridge University Press
ISBN: 1009275445
Category : Technology & Engineering
Languages : en
Pages : 406
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Book Description
Introduces the two most common numerical methods for heat transfer and fluid dynamics equations, using clear and accessible language. This unique approach covers all necessary mathematical preliminaries at the beginning of the book for the reader to sail smoothly through the chapters. Students will work step-by-step through the most common benchmark heat transfer and fluid dynamics problems, firmly grounding themselves in how the governing equations are discretized, how boundary conditions are imposed, and how the resulting algebraic equations are solved. Providing a detailed discussion of the discretization steps and time approximations, and clearly presenting concepts of explicit and implicit formulations, this graduate textbook has everything an instructor needs to prepare students for their exams and future careers. Each illustrative example shows students how to draw comparisons between the results obtained using the two numerical methods, and at the end of each chapter they can test and extend their understanding by working through the problems provided. A solutions manual is also available for instructors.
Author: Mark Stauffer
Publisher: BoD – Books on Demand
ISBN: 1789230845
Category : Science
Languages : en
Pages : 176
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Book Description
This book seeks to introduce the reader to current methodologies in analytical calibration and validation. This collection of contributed research articles and reviews addresses current developments in the calibration of analytical methods and techniques and their subsequent validation. Section 1, "Introduction," contains the Introductory Chapter, a broad overview of analytical calibration and validation, and a brief synopsis of the following chapters. Section 2 "Calibration Approaches" presents five chapters covering calibration schemes for some modern analytical methods and techniques. The last chapter in this section provides a segue into Section 3, "Validation Approaches," which contains two chapters on validation procedures and parameters. This book is a valuable source of scientific information for anyone interested in analytical calibration and validation.
