This book concentrates on the quality of electronic products. Electronics in general, including semiconductor technology and software, has become the key technology for wide areas of industrial production. In nearly all expanding branches of industry electronics, especially digital electronics, is involved. And the spread of electronic technology has not yet come to an end. This rapid development, coupled with growing competition and the shorter innovation cycle, have caused economic problems which tend to have adverse effects on quality. Therefore, good quality at low cost is a very attractive goal in industry today. The demand for better quality continues along with a demand for more studies in quality assurance. At the same time, many companies are experiencing a drop in profits just when better quality of their products is essential in order to survive against the competition. There have been many proposals in the past to improve quality without increase in cost, or to reduce cost for quality assurance without loss of quality. This book tries to summarize the practical content of many of these proposals and to give some advice, above all to the designer and manufacturer of electronic devices. It mainly addresses practically minded engineers and managers. It is probably of less interest to pure scientists. The book covers all aspects of quality assurance of components used in electronic devices. Integrated circuits (lCs) are considered to be the most important components because the degree of integration is still rising.

A practical guide to Quality by Design for pharmaceutical product development Pharmaceutical Quality by Design: A Practical Approach outlines a new and proven approach to pharmaceutical product development which is now being rolled out across the pharmaceutical industry internationally. Written by experts in the field, the text explores the QbD approach to product development. This innovative approach is based on the application of product and process understanding underpinned by a systematic methodology which can enable pharmaceutical companies to ensure that quality is built into the product. Familiarity with Quality by Design is essential for scientists working in the pharmaceutical industry. The authors take a practical approach and put the focus on the industrial aspects of the new QbD approach to pharmaceutical product development and manufacturing. The text covers quality risk management tools and analysis, applications of QbD to analytical methods, regulatory aspects, quality systems and knowledge management. In addition, the book explores the development and manufacture of drug substance and product, design of experiments, the role of excipients, multivariate analysis, and include several examples of applications of QbD in actual practice. This important resource: Covers the essential information about Quality by Design (QbD) that is at the heart of modern pharmaceutical development Puts the focus on the industrial aspects of the new QbD approach Includes several illustrative examples of applications of QbD in practice Offers advanced specialist topics that can be systematically applied to industry Pharmaceutical Quality by Design offers a guide to the principles and application of Quality by Design (QbD), the holistic approach to manufacturing that offers a complete understanding of the manufacturing processes involved, in order to yield consistent and high quality products.

Covers a widespread view of Quality by Design (QbD) encompassing the many stages involved in the development of a new drug product. The book provides a broad view of Quality by Design (QbD) and shows how QbD concepts and analysis facilitate the development and manufacture of high quality products. QbD is seen as a framework for building process understanding, for implementing robust and effective manufacturing processes and provides the underpinnings for a science-based regulation of the pharmaceutical industry. Edited by the three renowned researchers in the field, Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture guides pharmaceutical engineers and scientists involved in product and process development, as well as teachers, on how to utilize QbD practices and applications effectively while complying with government regulations. The material is divided into three main sections: the first six chapters address the role of key technologies, including process modeling, process analytical technology, automated process control and statistical methodology in supporting QbD and establishing the associated design space. The second section consisting of seven chapters present a range of thoroughly developed case studies in which the tools and methodologies discussed in the first section are used to support specific drug substance and drug-product QbD related developments. The last section discussed the needs for integrated tools and reviews the status of information technology tools available for systematic data and knowledge management to support QbD and related activities. Highlights Demonstrates Quality by Design (QbD) concepts through concrete detailed industrial case studies involving of the use of best practices and assessment of regulatory implications Chapters are devoted to applications of QbD methodology in three main processing sectors—drug substance process development, oral drug product manufacture, parenteral product processing, and solid-liquid processing Reviews the spectrum of process model types and their relevance, the range of state-of-the-art real-time monitoring tools and chemometrics, and alternative automatic process control strategies and methods for both batch and continuous processes The role of the design space is demonstrated through specific examples and the importance of understanding the risk management aspects of design space definition is highlighted Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture is an ideal book for practitioners, researchers, and graduate students involved in the development, research, or studying of a new drug and its associated manufacturing process.

Handbook of Analytical Quality by Design addresses the steps involved in analytical method development and validation in an effort to avoid quality crises in later stages. The AQbD approach significantly enhances method performance and robustness which are crucial during inter-laboratory studies and also affect the analytical lifecycle of the developed method. Sections cover sample preparation problems and the usefulness of the QbD concept involving Quality Risk Management (QRM), Design of Experiments (DoE) and Multivariate (MVT) Statistical Approaches to solve by optimizing the developed method, along with validation for different techniques like HPLC, UPLC, UFLC, LC-MS and electrophoresis. This will be an ideal resource for graduate students and professionals working in the pharmaceutical industry, analytical chemistry, regulatory agencies, and those in related academic fields. - Concise language for easy understanding of the novel and holistic concept - Covers key aspects of analytical development and validation - Provides a robust, flexible, operable range for an analytical method with greater excellence and regulatory compliance

An authoritative guide to optimizing design for manufacturability and reliability from a team of experts Design for Excellence in Electronics Manufacturing is a comprehensive, state-of-the-art book that covers design and reliability of electronics. The authors—noted experts on the topic—explain how using the DfX concepts of design for reliability, design for manufacturability, design for environment, design for testability, and more, reduce research and development costs and decrease time to market and allow companies to confidently issue warranty coverage. By employing the concepts outlined in Design for Excellence in Electronics Manufacturing, engineers and managers can increase customer satisfaction, market share, and long-term profits. In addition, the authors describe the best practices regarding product design and show how the practices can be adapted for different manufacturing processes, suppliers, use environments, and reliability expectations. This important book: Contains a comprehensive review of the design and reliability of electronics Covers a range of topics: establishing a reliability program, design for the use environment, design for manufacturability, and more Includes technical information on electronic packaging, discrete components, and assembly processes Shows how aspects of electronics can fail under different environmental stresses Written for reliability engineers, electronics engineers, design engineers, component engineers, and others, Design for Excellence in Electronics Manufacturing is a comprehensive book that reveals how to get product design right the first time.

J.M. Juran, whom Business Week calls, "the man who taught Japan how to manage for quality", presents a new, exhaustively comprehensive approach to planning, setting, and reaching goals in Juran's Quality Road Map. New emphasis is placed on setting goals, planning in "multifunctional" processes, establishing data bases, motivating managers and introducing quality planning into organizations. 30 line drawings.

If you design electronics for a living, you need Robust Electronic Design Reference Book. Written by a working engineer, who has put over 115 electronic products into production at Sycor, IBM, and Lexmark, Robust Electronic Design Reference covers all the various aspects of designing and developing electronic devices and systems that: -Work. -Are safe and reliable. -Can be manufactured, tested, repaired, and serviced. -May be sold and used worldwide. -Can be adapted or enhanced to meet new and changing requirements.

Quality by Design reflects the research and applied training conducted at Dartmouth Medical School under the leadership of Gene Nelson, Paul Batalden, and Marjorie Godfrey. The book includes the research results of high-performing clinical microsystems, illustrative case studies that highlight individual clinical programs, guiding principles that are easily applied, and tools, techniques, and methods that can be adapted by clinical practices and interdisciplinary clinical teams. The authors describe how to develop microsystems that can attain peak performance through active engagement of interdisciplinary teams in learning and applying improvement science and measurement; explore the essence of leadership for clinical Microsystems; show what mid-level leaders can do to enable peak performance at the front lines of care; outline the design and redesign of services and planning care to match patient needs with services offered; examine the issue of safety; describe the vital role of data in creating a rich and useful information environment; provide a core curriculum that can build microsystems’ capability, provide excellent care, promote a positive work environment, and contribute to the larger organization. Ancillary materials for use in classroom teaching, training, or coaching are available at https://clinicalmicrosystem.org/

Next Generation HALT and HASS presents a major paradigm shift from reliability prediction-based methods to discovery of electronic systems reliability risks. This is achieved by integrating highly accelerated life test (HALT) and highly accelerated stress screen (HASS) into a physics-of-failure-based robust product and process development methodology. The new methodologies challenge misleading and sometimes costly mis-application of probabilistic failure prediction methods (FPM) and provide a new deterministic map for reliability development. The authors clearly explain the new approach with a logical progression of problem statement and solutions. The book helps engineers employ HALT and HASS by illustrating why the misleading assumptions used for FPM are invalid. Next, the application of HALT and HASS empirical discovery methods to quickly find unreliable elements in electronics systems gives readers practical insight to the techniques. The physics of HALT and HASS methodologies are highlighted, illustrating how they uncover and isolate software failures due to hardware-software interactions in digital systems. The use of empirical operational stress limits for the development of future tools and reliability discriminators is described. Key features: * Provides a clear basis for moving from statistical reliability prediction models to practical methods of insuring and improving reliability. * Challenges existing failure prediction methodologies by highlighting their limitations using real field data. * Explains a practical approach to why and how HALT and HASS are applied to electronics and electromechanical systems. * Presents opportunities to develop reliability test discriminators for prognostics using empirical stress limits. * Guides engineers and managers on the benefits of the deterministic and more efficient methods of HALT and HASS. * Integrates the empirical limit discovery methods of HALT and HASS into a physics of failure based robust product and process development process.

Pharmaceutical Quality by Design: Principles and Applications discusses the Quality by Design (QbD) concept implemented by regulatory agencies to ensure the development of a consistent and high-quality pharmaceutical product that safely provides the maximum therapeutic benefit to patients. The book walks readers through the QbD framework by covering the fundamental principles of QbD, the current regulatory requirements, and the applications of QbD at various stages of pharmaceutical product development, including drug substance and excipient development, analytical development, formulation development, dissolution testing, manufacturing, stability studies, bioequivalence testing, risk and assessment, and clinical trials. Contributions from global leaders in QbD provide specific insight in its application in a diversity of pharmaceutical products, including nanopharmaceuticals, biopharmaceuticals, and vaccines. The inclusion of illustrations, practical examples, and case studies makes this book a useful reference guide to pharmaceutical scientists and researchers who are engaged in the formulation of various delivery systems and the analysis of pharmaceutical product development and drug manufacturing process. - Discusses vital QbD precepts and fundamental aspects of QbD implementation in the pharma, biopharma and biotechnology industries - Provides helpful illustrations, practical examples and research case studies to explain QbD concepts to readers - Includes contributions from global leaders and experts from academia, industry and regulatory agencies