Analytical Method Validation and Instrument Performance Verification


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.




Basic Method Validation


Book Description

With the publication of the Final CLIA Rule, new method validation responsibilities came to the laboratory. Previously, moderately complex methods did not need to be validated. But the Final Rule combined moderately and highly complex methods into a category of non-waived methods. Now Laboratories must validate all non-waived methods introduced after April 24, 2003. To help laboratory professionals comply with these new regulatory changes, a second edition of this manual was prepared. Book jacket.




Basic Method Validation


Book Description




Basic Method Validation


Book Description




Experimentation, Validation, and Uncertainty Analysis for Engineers


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.










Manual of Molecular and Clinical Laboratory Immunology, 2 Volume Set


Book Description

THE authoritative guide for clinical laboratory immunology For nearly 50 years, the Manual of Molecular and Clinical Laboratory Immunology has been the premier resource for laboratories, students, and professionals involved in the clinical and technical details of diagnostic immunology testing. The 9th Edition continues its tradition of providing comprehensive clinical and technical information on the latest technologies used in medical and diagnostic immunology. Led by a world-renowned group of authors and editors, this new edition reflects substantial changes aimed at improving and updating the Manual's utility while reflecting the significant transformations that have occurred since the last edition, including the revolution of gene editing and the widespread adoption of molecularly engineered cellular therapies. Topical highlights include: Laboratory Management: three new chapters cover essential aspects of quality assurance, quality improvement, and quality management, aligning with the increasingly stringent and demanding regulatory environment. Inborn Errors of Immunity: the primary immunodeficiency section has been completely updated to align with the latest International Union of Immunological Societies' classifications of inborn errors of immunity. Functional Cellular Assays: expanded content includes detailed discussions on various functional assays critical for modern immunologic testing. Autoimmune Diseases: expanded chapters on systemic and organ-specific autoimmune disorders, including new chapters on Sjögren's syndrome and deficiency of ADA2, as well as significant updates on organ-specific autoimmune diseases. Transplantation Immunology: updated chapters detail the assessment of immune reconstitution and ABO testing, reflecting latest practices. The 9th Edition of the Manual of Molecular and Clinical Laboratory Immunology serves as an invaluable resource for laboratory directors, clinicians, laboratory managers, technologists, and students. It provides critical insights into the selection, application, and interpretation of immunologic tests, offering practical guidance on troubleshooting, clinical application, and an understanding of test limitations. This comprehensive and up-to-date manual remains an essential tool for anyone involved in the diagnosis, evaluation, and management of immune-mediated and immune system-related disorders.




Verification, Validation, and Testing of Engineered Systems


Book Description

Systems' Verification Validation and Testing (VVT) are carried out throughout systems' lifetimes. Notably, quality-cost expended on performing VVT activities and correcting system defects consumes about half of the overall engineering cost. Verification, Validation and Testing of Engineered Systems provides a comprehensive compendium of VVT activities and corresponding VVT methods for implementation throughout the entire lifecycle of an engineered system. In addition, the book strives to alleviate the fundamental testing conundrum, namely: What should be tested? How should one test? When should one test? And, when should one stop testing? In other words, how should one select a VVT strategy and how it be optimized? The book is organized in three parts: The first part provides introductory material about systems and VVT concepts. This part presents a comprehensive explanation of the role of VVT in the process of engineered systems (Chapter-1). The second part describes 40 systems' development VVT activities (Chapter-2) and 27 systems' post-development activities (Chapter-3). Corresponding to these activities, this part also describes 17 non-testing systems' VVT methods (Chapter-4) and 33 testing systems' methods (Chapter-5). The third part of the book describes ways to model systems' quality cost, time and risk (Chapter-6), as well as ways to acquire quality data and optimize the VVT strategy in the face of funding, time and other resource limitations as well as different business objectives (Chapter-7). Finally, this part describes the methodology used to validate the quality model along with a case study describing a system's quality improvements (Chapter-8). Fundamentally, this book is written with two categories of audience in mind. The first category is composed of VVT practitioners, including Systems, Test, Production and Maintenance engineers as well as first and second line managers. The second category is composed of students and faculties of Systems, Electrical, Aerospace, Mechanical and Industrial Engineering schools. This book may be fully covered in two to three graduate level semesters; although parts of the book may be covered in one semester. University instructors will most likely use the book to provide engineering students with knowledge about VVT, as well as to give students an introduction to formal modeling and optimization of VVT strategy.