Download or read book Validating a Best Practice written by Yves Van Nuland and published by CRC Press. This book was released on 2020-07-26 with total page 192 pages. Available in PDF, EPUB and Kindle. Book excerpt: Sharing Best Practices across industries and functions is an accepted approach to continuous improvement. The Benchmarking trend of the 1990s has evolved with the help of competitive analysis, performance excellence awards, and other corporate recognition programs into an ongoing documentation of what works. Bob Camp introduced benchmarking against a Best Practice based on his work at Xerox in the 1980s. Case studies abound documenting Best Practice functions and processes. Some case studies use the words “Best Practice” without evidence that the process, results, or methods are, indeed, superior. What is missing is a comprehensive model for assessing and writing a Best Practice that provides sufficient information to use as an effective benchmark. This book provides that comprehensive model. Today’s consumers expect products and services to be of high quality, reliable, and user-friendly. This is the result of years of continuous improvement and innovation by producers. Although many organizations strive for excellent results, there is still room for improvement. Unfortunately, leaders don’t always have methods and tools to measure or assess that degree of excellence. If leaders could use a tool to discover how good their approaches and methods are, and how excellent their achieved results are, they could plan further improvements. The goal is to achieve excellent results. The tool described in this book guides leaders to achieve that excellence.

Download or read book Method Validation in Pharmaceutical Analysis written by Joachim Ermer and published by John Wiley & Sons. This book was released on 2006-03-06 with total page 418 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Facility Validation written by Graham C. Wrigley and published by CRC Press. This book was released on 2004-03-29 with total page 152 pages. Available in PDF, EPUB and Kindle. Book excerpt: Often considered a necessary evil by the pharmaceutical industry, validation is still understood by many as unrestrained bureaucracy, paperwork, and procedures whose roots and logic are obscure and only serve to slow down progress. Thoroughly defining the philosophy, application, and processes, Facility Validation: Theory, Practice, and Tools explo

Download or read book Scale Development written by Robert F. DeVellis and published by SAGE Publications. This book was released on 2016-03-30 with total page 160 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the Fourth Edition of Scale Development, Robert F. DeVellis demystifies measurement by emphasizing a logical rather than strictly mathematical understanding of concepts. The text supports readers in comprehending newer approaches to measurement, comparing them to classical approaches, and grasping more clearly the relative merits of each. This edition addresses new topics pertinent to modern measurement approaches and includes additional exercises and topics for class discussion. Available with Perusall—an eBook that makes it easier to prepare for class Perusall is an award-winning eBook platform featuring social annotation tools that allow students and instructors to collaboratively mark up and discuss their SAGE textbook. Backed by research and supported by technological innovations developed at Harvard University, this process of learning through collaborative annotation keeps your students engaged and makes teaching easier and more effective. Learn more.

Download or read book The Power of Validation written by Karyn D. Hall and published by New Harbinger Publications. This book was released on 2011-12-01 with total page 205 pages. Available in PDF, EPUB and Kindle. Book excerpt: Validation—recognizing and accepting your child’s thoughts and feelings, regardless of whether or not you feel that your child should be experiencing them—helps children develop a lifelong sense of self-worth. Children who are validated feel reassured that they will be accepted and loved regardless of their feelings, while children who are not validated are more vulnerable to peer pressure, bullying, and emotional and behavioral problems. The Power of Validation is an essential resource for parents seeking practical skills for validating their child’s feelings without condoning tantrums, selfishness, or out-of-control behavior. You’ll practice communicating with your child in ways that instantly impact his or her mood and help your child develop the essential self-validating skills that set the groundwork for confidence and self-esteem in adolescence and beyond. “...There is valuable advice here. This approach takes mindfulness, patience, and a long-term vision, but parents who are able to help their children trust their emotional landscapes will have an easier time of scaffolding to higher reasoning, in addition to more secure relationships with their youngsters. Highly recommended.” —Library Journal, STARRED REVIEW, Rebecca Raszewski, University of Illinois Library, Chicago

Download or read book Validating Product Ideas written by Tomer Sharon and published by Rosenfeld Media. This book was released on 2016-01-19 with total page 345 pages. Available in PDF, EPUB and Kindle. Book excerpt: Want to know what your users are thinking? If you’re a product manager or developer, this book will help you learn the techniques for finding the answers to your most burning questions about your customers. With step-by-step guidance, Validating Product Ideas shows you how to tackle the research to build the best possible product.

Download or read book Project Management Best Practices Achieving Global Excellence written by Harold Kerzner and published by John Wiley & Sons. This book was released on 2018-02-07 with total page 784 pages. Available in PDF, EPUB and Kindle. Book excerpt: The comprehensive guide to project management implementation, updated with the latest in the field Project management has spread beyond the IT world to become a critical part of business in every sphere; built on efficiency, analysis, and codified practice, professional project management leads to the sort of reproducible results and reliable processes that make a business successful. Project Management Best Practices provides implementation guidance for every phase of a project, based on the real-world methodologies from leading companies around the globe. Updated to align with the industry’s latest best practices, this new Fourth Edition includes new discussion on Agile and Scrum, tradeoffs and constraints, Portfolio PMO tools, and much more. Get up-to-date information on the latest best practices that add value at every level of an organization Gain insight from more than 50 project managers at world-class organizations including Airbus, Heineken, RTA, IBM, Hewlett-Packard, Sony, Cisco, Nokia, and more Delve deeper into implementation guidance for Agile, Scrum, and Six Sigma Explore more efficient methodologies, training, measurement, and metrics that boost organization-wide performance Adopt new approaches to culture and behavioral excellence, including conflict resolution, situational leadership, proactive management, staffing, and more Ideal for both college and corporate training, this book is accompanied by an Instructor’s Manual and PowerPoint lecture slides that bring project management concepts right into the classroom. As the field continues to grow and evolve, it becomes increasingly important to stay current with new and established practices; this book provides comprehensive guidance on every aspect of project management, with invaluable real-world insight from leaders in the field.

Download or read book Software Quality Approaches Testing Verification and Validation written by Michael Haug and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 308 pages. Available in PDF, EPUB and Kindle. Book excerpt: C. Amting Directorate General Information Society, European Commission, Brussels th Under the 4 Framework of European Research, the European Systems and Soft ware Initiative (ESSI) was part ofthe ESPRIT Programme. This initiative funded more than 470 projects in the area ofsoftware and system process improvements. The majority of these projects were process improvement experiments carrying out and taking up new development processes, methods and technology within the software development process ofa company. In addition, nodes (centres ofexper tise), European networks (organisations managing local activities), training and dissemination actions complemented the process improvementexperiments. ESSI aimed at improving the software development capabilities of European enterprises. It focused on best practice and helped European companies to develop world class skills and associated technologies to build the increasingly complex and varied systems needed to compete in the marketplace. The dissemination activities were designed to build a forum, at European level, to exchange information and knowledge gained within process improvement ex periments. Their major objective was to spread the message and the results of experiments to awider audience, through a variety ofdifferent channels. The European Experience Exchange ~UR~X) project has been one ofthese dis semination activities within the European Systems and Software Initiative.~UR~)( has collected the results of practitioner reports from numerous workshops in Europe and presents, in this series of books, the results of Best Practice achieve ments in European Companies over the last few years.

Download or read book Validation of Alternative Methods for Toxicity Testing written by Chantra Eskes and published by Springer. This book was released on 2016-09-26 with total page 418 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides information on best practices and new thinking regarding the validation of alternative methods for toxicity testing. It covers the validation of experimental and computational methods and integrated approaches to testing and assessment. Validation strategies are discussed for methods employing the latest technologies such as tissue-on-a-chip systems, stem cells and transcriptomics, and for methods derived from pathway-based concepts in toxicology. Validation of Alternative Methods for Toxicity Testing is divided into two sections, in the first, practical insights are given on the state-of-the-art and on approaches that have resulted in successfully validated and accepted alternative methods. The second section focuses on the evolution of validation principles and practice that are necessary to ensure fit-for-purpose validation that has the greatest impact on international regulatory acceptance of alternative methods. In this context validation needs to keep pace with the considerable scientific advancements being made in toxicology, the availability of sophisticated tools and techniques that can be applied in a variety of ways, and the increasing societal and regulatory demands for better safety assessment. This book will be a useful resource for scientists in the field of toxicology, both from industry and academia, developing new test methods, strategies or techniques, as well as Governmental and regulatory authorities interested in understanding the principles and practicalities of validation of alternative methods for toxicity testing.

Download or read book ISPE Good Practice Guide written by Ispe and published by . This book was released on 2019-03-25 with total page 204 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Validity and Validation written by Catherine S. Taylor and published by Oxford University Press. This book was released on 2013-09-03 with total page 217 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Understanding Research series focuses on the process of writing up social research. The series is broken down into three categories: Understanding Statistics, Understanding Measurement, and Understanding Qualitative Research. The books provide researchers with guides to understanding, writing, and evaluating social research. Each volume demonstrates how research should be represented, including how to write up the methodology as well as the research findings. Each volume also reviews how to appropriately evaluate published research. Validity and Validation is an introduction to validity theory and to the methods used to obtain evidence for the validity of research and assessment results. The book pulls together the best thinking from educational and psychological research and assessment over the past 50 years. It briefly describes validity theory's roots in the philosophy of science. It highlights the ways these philosophical perspectives influence concepts of internal and external validity in research methodology, as well as concepts of validity and reliability in educational and psychological tests and measurements. Each chapter provides multiple examples (e.g., research designs and examples of output) to help the readers see how validation work is done in practice, from the ways we design research studies to the ways we interpret research results. Of particular importance is the practical focus on validation of scores from tests and other measures. The book also addresses strategies for investigating the validity of inferences we make about examinees using scores from assessments, as well as how to investigate score uses, the value implications of score interpretations, and the social consequences of score use. With this foundation, the book presents strategies for minimizing threats for validity as well as quantitative and qualitative methods for gathering evidence for the validity of scores.

Download or read book Evolution of Translational Omics written by Institute of Medicine and published by National Academies Press. This book was released on 2012-09-13 with total page 354 pages. Available in PDF, EPUB and Kindle. Book excerpt: Technologies collectively called omics enable simultaneous measurement of an enormous number of biomolecules; for example, genomics investigates thousands of DNA sequences, and proteomics examines large numbers of proteins. Scientists are using these technologies to develop innovative tests to detect disease and to predict a patient's likelihood of responding to specific drugs. Following a recent case involving premature use of omics-based tests in cancer clinical trials at Duke University, the NCI requested that the IOM establish a committee to recommend ways to strengthen omics-based test development and evaluation. This report identifies best practices to enhance development, evaluation, and translation of omics-based tests while simultaneously reinforcing steps to ensure that these tests are appropriately assessed for scientific validity before they are used to guide patient treatment in clinical trials.

Download or read book Basic Method Validation written by James O. Westgard and published by AACC Press. This book was released on 2003-01-01 with total page 292 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Adverse Impact and Test Validation written by Dan Biddle and published by Routledge. This book was released on 2017-05-15 with total page 153 pages. Available in PDF, EPUB and Kindle. Book excerpt: Adverse impact analyses and test validation promote social justice and equity. Employers who unknowingly use invalid tests or recruitment procedures that have an adverse impact are reducing minority and/or female representation in their workforce, unfairly screening out qualified workers and (worst of all) just plain discriminating. Dan Biddle's Adverse Impact and Test Validation provides you with analyses that allow you to identify which of your selection procedures have adverse impact. The validation steps will help you decide whether to keep the selection procedure (because it's valid), change it, or stop using it altogether. This second edition contains new material on using multiple regression to evaluate pay practices and provides step-by-step instructions for using SPSS or Excel for evaluating your company's pay practices for possible inequities. New content on how to define "Internet applicants" and set up defensible Basic Qualifications (BQs) for online recruiting will help employers ensure compliance with EEO regulations and screen in qualified applicants. Specific guidelines for developing and validating written job knowledge tests, such as those used for police and fire promotional testing, have also been included in this new edition. The downloadable resources include tools (which may be used on a trial evaluation basis) describing several of the functions described in the book, including Adverse Impact Toolkit®, Test Validation and Analysis Program® (TVAP®), Guidelines Oriented Job Analysis® (GOJA®) Manual, and Content Validity Checklists. This highly pragmatic guide goes beyond the concepts, theories and ideas behind adverse impact and test validation. It not only explains what to do but crucially, also shows you how to do it. The second edition has been expanded to include two brand new chapters with a new Appendix and comes with new editions of the accompanying software. As a means of protecting your organization from litigation, damage to employee relations and to your corporate reputation, Adverse Impact and Test Validation is a 'must-have' purchase for human resource professionals, testing and recruitment specialists.

Download or read book Validity and Validation in Social Behavioral and Health Sciences written by Bruno D. Zumbo and published by Springer. This book was released on 2014-09-26 with total page 329 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book combines an overview of validity theory, trends in validation practices and a review of standards and guidelines in several international jurisdictions with research synthesis of the validity evidence in different research areas. An overview of theory is both useful and timely, in view of the increased use of tests and measures for decision-making, ranking and policy purposes in large-scale testing, assessment and social indicators and quality of life research. Research synthesis is needed to help us assemble, critically appraise and integrate the overwhelming volume of research on validity in different contexts. Rather than examining whether any given measure is “valid”, the focus is on a critical appraisal of the kinds of validity evidence reported in the published research literature. The five sources of validity evidence discussed are: content-related, response processes, internal structure, associations with other variables and consequences. The 15 syntheses included here, represent a broad sampling of psychosocial, health, medical and educational research settings, giving us an extensive evidential basis to build upon earlier studies. The book concludes with a meta-synthesis of the 15 syntheses and a discussion of the current thinking of validation practices by leading experts in the field.

Download or read book Validating Chromatographic Methods written by David M. Bliesner and published by John Wiley & Sons. This book was released on 2006-09-11 with total page 301 pages. Available in PDF, EPUB and Kindle. Book excerpt: All the information and tools needed to set up a successful method validation system Validating Chromatographic Methods brings order and Current Good Manufacturing Practices to the often chaotic process of chromatographic method validation. It provides readers with both the practical information and the tools necessary to successfully set up a new validation system or upgrade a current system to fully comply with government safety and quality regulations. The net results are validated and transferable analytical methods that will serve for extended periods of time with minimal or no complications. This guide focuses on high-performance liquid chromatographic methods validation; however, the concepts are generally applicable to the validation of other analytical techniques as well. Following an overview of analytical method validation and a discussion of its various components, the author dedicates a complete chapter to each step of validation: Method evaluation and further method development Final method development and trial method validation Formal method validation and report generation Formal data review and report issuance Templates and examples for Methods Validation Standard Operating Procedures, Standard Test Methods, Methods Validation Protocols, and Methods Validation Reports are all provided. Moreover, the guide features detailed flowcharts and checklists that lead readers through every stage of method validation to ensure success. All of the templates are also included on a supplementary support site, enabling readers to easily work with and customize them. For scientists and technicians new to method validation, this guide provides all the information and tools needed to develop a top-quality system. For those experienced with method validation, the guide helps to upgrade and improve existing systems.

Download or read book Accelerated Testing and Validation written by Alex Porter and published by Elsevier. This book was released on 2004-07-01 with total page 257 pages. Available in PDF, EPUB and Kindle. Book excerpt: Accelerated Testing and Validation Methods is a cross-disciplinary guide that describes testing and validation tools and techniques throughout the product development process. Alex Porter not only focuses on what information is needed but also on what tools can produce the information in a timely manner. From the information provided, engineers and managers can determine what data is needed from a test and validation program and then how to select the best, most effective methods for obtaining the data.This book integrates testing and validation methods with a business perspective so readers can understand when, where, and how such methods can be economically justified. Testing and validation is about generating key information at the correct time so that sound business and engineering decisions can be made. Rather than simply describing various testing and validation techniques, the author offers readers guidance on how to select the best tools for a particular need, explains the appropriateness of different techniques to various situations and shows how to deploy them to ensure the desired information is accurately gathered. Emphasizes developing a strategy for testing and validation Teaches how to design a testing and validation program that deliver information in a timely and cost-effective manner