Bringing together the concepts of design control and reliability engineering, this book is a must for medical device manufacturers. It helps them meet the challenge of designing and developing products that meet or exceed customer expectations and also meet regulatory requirements. Part One covers motivation for design control and validation, design control requirements, process validation and design transfer, quality system for design control, and measuring design control program effectiveness. Part Two discusses risk analysis and FMEA, designing-in reliability, reliability and design verification, and reliability and design validation.

Written by an expert for those who must design validatable cleaning processes and then validate those processes, this book discusses interdependent topics from various technical areas and disciplines. It shows how each piece of the cleaning process fits into the validation program, making it more defensible in both internal quality audits and external regulatory audits. Designed for use in the overall validation program, the book demonstrates how to build a comprehensive program, and includes discussion and examples of cleaning systems, regulatory requirements, and special topics and issues. It provides an FDA cleaning validation guidance document and a comprehensive glossary.

This definitive reference explores the various aspects of multiparticulate dosage form development-assessing the in vivo behavior and performance of multiparticulates as well as comparing their market position to other dosage forms. Discussing-for the first time in a comprehensive manner-alternative pelletization techniques such as balling (spherical agglomeration), spray congealing, and cryopelletization, Multiparticulate Oral Drug Delivery describes formulation and processing variables that affect the formation, integrity, and performance of coatings derived from molten materials and polymeric solutions and dispersions analyzes the biopharmaceutical aspects and in vivo performance of multiparticulate drug delivery systems details the idiosyncrasies of the manufacturing process of hard-shell gelatin capsules explains the different kinds of packaging materials and machinery and the importance of packaging during the development phase and beyond previews the marketing considerations of multiparticulate systems in the years to come presents practical solutions to problems encountered in the area of film-coating processes and more!

The healthcare professionals who save and extend our lives are helpless without the medicines and technologies that have revolutionised medical care. But the industry that invents, makes and provides these indispensable tools is transforming under the pressure of ageing populations, globalisation and revolutions in biological and information technology. How this industry adapts and evolves is vitally important to every one of us. This book looks inside the heads and hearts of the people who lead the global pharmaceutical and medical technology industry. It describes how they make sense of their markets and the wider life sciences economy. It reveals what they have learned about how to lead large, complex organisations to compete in dynamic, global markets. Leadership in the Life Sciences is essential reading for anyone working in or with the pharmaceutical and medical technology industry and its halo of supporting companies. Written as ten succinct lessons, it gives the reader unique insight into what the industry's leaders are thinking. Covering topics from leadership to organisational culture, from change management to digital disruption and from competitive strategy to value-creation, each chapter distils the accumulated wisdom of those who lead the complex and turbulent life sciences industry.

Fibres to Smart Textiles: Advances in Manufacturing, Technologies, and Applications offers comprehensive coverage of the fundamentals and advances in the textile and clothing manufacturing sectors. It describes the basics of fibres, yarns, and fabrics and their end use in the latest developments and applications in the field and addresses environmental impacts from textile processes and how to minimize them. This book serves as a single comprehensive source discussing textile fibres, yarn formation, filament formation techniques, woven fabric formation, knitting technologies, nonwoven manufacturing technologies, braiding technologies, and dyeing, printing, and finishing processes. Testing of textile materials, environmental impacts of textile processes and use of CAD and CAM in designing textile products are also included. The book also discusses applications including textile composites and biocomposites, technical textiles, smart textiles, and nanotextiles. With chapters authored by textile experts, this practical book offers guidance to professionals in textile and clothing manufacturing and shows how to avoid potential pitfalls in product development.

First published in 1990, this book provides an overview of the global distribution of the electronics industry and the structural factors which promoted this distribution by the end of the 1980s. Regarded as a 'flagship' sector in both advanced and developing countries, the electronics industry is encouraged by governments everywhere. Covering both the civilian and the military sides of the industry, Professor Todd reflects on the future of civilian electronics in the light of its global segmentation, and hints at the fundamental role of governments in the unfolding of both civilian and defence-electronics developments. He also endorses the overwhelming significance of strategies being played by electronics enterprises in both the USA and Japan.

Originally published in 1999 after a decade of research and extensive interviews with some of Toyota's top executives, this book examines organizational purpose: what it is, how it is crafted, how does it relate to strategy and objectives and how does it relate to decisions and actions that ultimately produce organizational results. The author explains why Toyoto Motor Corporation was selected to study corporate purpose and examines the various factors that influence purpose. An overview is given of Toyota in the 1990s and its operating environment, particularly outlining the importance of the Japanes motor industry to Japanese society. Operational objectives of Toyota are analyzed and research findings, data and analysis related to Toyota's purpose are presented and the implications described. In the appendix, the detail of the research methodology of this study is included.

This edited book focuses on the organization and meaning of craft work in contemporary society. It considers the relationship between craft and place and how this enables the construction of a meaningful relationship with objects of production and consumption. The book explores the significance of raw materials, the relationship between the body, the crafted object and the mind, and the importance of skill, knowledge and learning in the making process. Through this, it raises important questions about the role of craft in facing future challenges by challenging the logic of globalized production and consumption. The Organization of Craft Work encompasses international analyses from the United States, France, Italy, Australia, Canada, the UK and Japan involving a diverse range of sectors, including brewing, food and wine production, clothing and shoe making, and perfumery. The book will be of interest to students and academic researchers in organization studies, marketing and consumer behaviour, business ethics, entrepreneurship, sociology of work, human resource management, cultural studies, geography, and fashion and design. In addition, the book will be of interest to practitioners and organizations with an interest in the development and promotion of craft work.

Wine, Terroir and Utopia critically explores these three concepts from multi-disciplinary and intersecting perspectives, focusing on the ways in which they collide to make new worlds, new wines, new places and new peoples. Wine, terroir and utopia are all rooted in natural, spatial and temporal realities, yet all are unable to exist without purposeful human intervention. This edited volume highlights the theoretical and analytical lens of diverse scholars, who critically discuss a dazzling array of intersecting realities and imaginaries - economic, political, cultural, social and geological - and in doing this challenge many of our deeply-held responses to utopia. Drawing on an impressive range of international examples from South Africa to Bordeaux to New Zealand, the chapters adopt a range of theoretical and methodological approaches. This volume will be of great interest to upper level students, researchers and academics in the fields of Sociology, Geography, Tourism, Hospitality, Wine Studies and Cultural Studies. It will also greatly appeal to practitioners and enthusiasts in the worlds of wine production, consumption and marketing.

Within a mere decade, hospital pharmacies throughout the Tibetan areas of the People's Republic of China have been converted into pharmaceutical companies. Confronted with the logic of capital and profit, these companies now produce commodities for a nationwide market. While these developments are depicted as a big success in China, they have also been met with harsh criticism in Tibet. At stake is a fundamental (re-)manufacturing of Tibetan medicine as a system of knowledge and practice. Being important both to the agenda of the Party State's policies on Tibet and to Tibetan self-understanding, the Tibetan medicine industry has become an arena in which different visions of Tibet's future clash.

Divided into three basic sections, this unique resource provides an understandable and implementable approach to inserting Lean in a manufacturing operation, pointing out the stumbling blocks and pitfalls to avoid. Its goal is to to help American manufacturing more effectively go about the task of making Lean a viable process. The significance of the work is that, if followed, it could change the entire course of how Lean Manufacturing is implemented in the United States and help manufacturing, in general, to become more competitive on a world wide scale. The first section addresses the typical difficulties that manufacturing operations in the United States have with the implementation of Lean Manufacturing - pointing to three basic issues which if addressed and resolved, would serve to move the process forward in a much more rapid and effective manner. The second section focuses on how to fully resolve the issues noted and details four levels of Lean Implementation and how they can be measured, in terms of progress. The third section deals with the more advanced aspects of Lean Manufacturing, including such things as how to engage administrative and supporting functions in the process (Accounting, Materials, Sales and Marketing, etc.); How and why to perform a Core Process Analysis (in order to decide which processes should be considered for outsourcing); How to incorporate "Owner-Operators" in the process; the importance of 18 month rolling implementation plan and more. It is sure to be found useful by high level manufacturing executives and leadership at a factory level, as well as students in a Manufacturing and Industrial Engineering curriculum. Provides readers with a clear path to inserting Lean in a manufacturing operation and a step by step approach to getting there. Includes numerous charts, graphs and window diagrams associated with the "how to" - along with specific training, schedules. Offers some unique insight into where Toyota placed a very important focus verses what is typically understood and/or accepted as the general path of implementation it took. Contains a list of important "Key Reflections" at the end of each chapter. Introduction The Basic Flaws and Misconceptions About Lean As a Plant's Equipment Goes, so Goes Lean Accepting the Need for Change Setting the Stage Examining Level One Lean in Closer Detail Putting It All Together and Making It Happen The Search for Greatness

To the surprise of many, regionally embedded clusters of small to medium sized businesses have continued to exist in spite of industrialisation and mass production. While scholars have discovered that the advantages of embeddedness in terms of industrialisation were situated in interfirm cooperation and conflict resolving mechanisms, it is far less clear how changing historical circumstances on the world market, i.e. globalisation, affected such systems. Taking a look inside Leipzig, a capital of the global fur industry between 1870 and 1939 with its numerous highly specialised businesses, both in production as well as trade, World Market Transformation examines the robustness of district firms within the highly volatile international fur business. This book examines how firm embeddedness not only served to overcome challenges related to industrialisation, but also strengthened the abilities of cluster firms to deal with changing world market circumstances. World Market Transformation integrates the "interior-biased" research tradition on local business systems and industrial districts into the "exterior" fields of global and transnational history. It is demonstrated that the local business district not only emerged because of the expansion of international trade, but that district processes of interfirm cooperation also gave shape to the spatial distribution, conventions and structures of the very same world market. The analysis of embedded communities thus offers an important instrument to examine phenomena of economic globalisation, but also how such macro-economic developments have been shaped and actively constructed by local actors.

First published in 1991, this book offers a thorough examination of the decline of heavy industry in industrialised countries in the West, which focuses on problems in the shipbuilding industry. Todd argues that three points are central to its demise: industrial life cycles, the international division of labour and the energy crises of 1973. His work begins with despondency in western shipbuilding, going back as early as 1956, when Japan usurped Britain as the pre-eminent ship producer. The book goes on to explore international trade and industry in the second half of the 20th century, with analysis on industrial reorganisation and East Asian conglomerates, diversification with the marine industries, and shipbuilding in Brazil, India, and China.

Appraising cancer as a major medical market in the 2010s, Wall Street investors placed their bets on single-technology treatment facilities costing $100-$300 million each. Critics inside medicine called the widely-publicized proton-center boom "crazy medicine and unsustainable public policy." There was no valid evidence, they claimed, that proton beams were more effective than less costly alternatives. But developers expected insurance to cover their centers' staggeringly high costs and debts. Was speculation like this new to health care? Cancer, Radiation Therapy, and the Market shows how the radiation therapy specialty in the United States (later called radiation oncology) coevolved with its device industry throughout the twentieth-century. Academic engineers and physicians acquired financing to develop increasingly powerful radiation devices, initiated companies to manufacture the devices competitively, and designed hospital and freestanding procedure units to utilize them. In the process, they incorporated market strategies into medical organization and practice. Although palliative benefits and striking tumor reductions fueled hopes of curing cancer, scientific research all too often found serious patient harm and disappointing beneficial impact on cancer survival. This thoroughly documented and provocative inquiry concludes that public health policy needs to re-evaluate market-driven high-tech medicine and build evidence-based health care systems.

First published in 1957, this book is a detailed analysis on Christian Democracy, a movement backed by Protestants as well as Catholics, which has become one of the great social forces of Western Europe. It is strong in eight countries. The first half of Fogarty's book sets out what the many Christian-Democratic movements stand for. The second part of the book shows how these movements began, how they have grown, changed, and consolidated, and how they developed into the mid-20th century. This is a broad and useful survey which delves the history, nature and significance of the Christian Democratic movements in Europe. In Fogarty's analysis, Christian Democracy may indeed bring about a renewed unity of the Christian tradition in Western society.

Export marketing holds the promise of vastly increased sales and market share for companies of all sizes. This book gives you the tools you need to go from ground zero -- virtually no experience in international marketing -- to the point where you can confidently pull together an effective plan for marketing your products overseas.

First published in 1955, this book offers a detailed history from the past to the mid-20th century on economic control. The book examines economic competition, particularly regarding the British economic system, and Fogarty looks at its scope, as well as its limits. This analysis considers working conditions in the mid-20th century, examining the impacts of industry on the life and work of the British agricultural population. The book first examines production decisions, arguing that a systematic and periodic overhaul of control mechanisms are required. Fogarty goes to give a detailed analysis on decisions about industry objectives. Ultimately, a broader look is given on the wider economic setting, and the definition of the economist is itself examined, taking into account the wider role that economics played in 20th century society.

First published in 1980, this compact and useful book uses the earliest volumes of government-published statistics, and with the aid of computer-generated cartography, transforms the numbers there reported into an arrondissement-by-arrondissement comparative picture of French agriculture in the mid-1830s. Clout reviews problems of rapid population growth, scarcely adequate domestic food supplies and primitive systems of transportation, while attention is drawn to spatial variations in agricultural activity and productivity. Commercial, high-yielding farming was best developed in a northern multi-nuclear region, comprising of Ile-de-France, Normandy and Nord, with smaller foci of commercial orientation along an eastern axis from Alsace to Marseilles and in western areas from the Loire to the middle of the Garonne valley. Clout concludes that the revolutionary promise of national economic unity was far from being realised in the 1830s and was not to be achieved until national systems of transport and education were firmly established later in the nineteenth century.

Providing detailed analysis of the thermal comfort assessment of clothing as the basis for developing standards, this book discusses the thermal protective role of clothing as a way of modelling heat transfer from the body, general thermal regulation of humans, and the importance of globally accepted test methods and standards to improve quality. New materials and discoveries in the study of thermal comfort necessitate the need for standard improvements and update. The development of international standards and the unification of testing methods is of crucial significance to ensure cost reduction and health protection. The book promotes instruments, methods, implementation of unified specifications, and the definition of standards so that a clear quality management system can be established, for both production systems and testing methods. It discusses standards in ergonomics of the thermal environment, clothing thermal characteristics, and subjective assessment of thermal comfort, which allows for systematic control of the measuring methods and the services and final products that are distributed on the global market. This book is aimed at industry professionals, researchers, and advanced students working in textile and clothing engineering, comfort testing, and ergonomics.

Optimization and decision making are integral parts of any manufacturing process and management system. The objective of this book is to demonstrate the confluence of theory and applications of various types of multi-criteria decision making and optimization techniques with reference to textile manufacturing and management. Divided into twelve chapters, it discusses various multi-criteria decision-making methods such as AHP, TOPSIS, ELECTRE, and optimization techniques like linear programming, fuzzy linear programming, quadratic programming, in textile domain. Multi-objective optimization problems have been dealt with two approaches, namely desirability function and evolutionary algorithm. Key Features Exclusive title covering textiles and soft computing fields including optimization and decision making Discusses concepts of traditional and non-traditional optimization methods with textile examples Explores pertinent single-objective and multi-objective optimizations Provides MATLAB coding in the Appendix to solve various types of multi-criteria decision making and optimization problems Includes examples and case studies related to textile engineering and management

This book addresses the production practices employed in the production of food animals and animal products that enable marketers to sell a variety of products to meet consumer demand. Food animal production practices have come under increased scrutiny by consumers who object to inputs and practices. The industry has been a proponent of using technologies to reduce production costs, resulting in lower-priced meat and animal food products, and now consumers are starting to look at other objectives. This book considers the key issues of concern to consumers, including the treatment of animals, the use of antibiotics, feed additives and hormones, and how these are monitored, regulated, and communicated to consumers. It also reviews labeling and information provided to consumers, including organic, genetic engineering, welfare standards, and place of origin. While the main focus is on the United States, there are descriptions of European practices and legislation. Overall, it aims to provide an objective and balanced appraisal, which will be of interest to advanced students and researchers in agricultural, food and environmental economics, law and policy, and animal production and welfare. It will also be very useful for early career professionals in the food and agricultural sectors.

Strategic success of industry depends upon manufacturing competencies (i.e., the competitive advantage to ensure better quality and reliability), which will increase sales and create a sound customer base. Competitive priorities are the operating advantages that are assessed, evaluated, and measured within the parameters of cost, quality, time, design, and flexibility. The book explains the manufacturing competencies upon which the strategic success of the automobile industry depends. The impact of manufacturing competency on strategic success is analyzed and modelled using suitable qualitative and quantitative techniques. Key Features Outlines manufacturing competencies in correlation with successful strategic planning for current manufacturing environment Provides methodology or guidelines for linking defined strategic plans with manufacturing competencies Defines strategic success in the context of the automobile industry Analyses and models manufacturing competency impacts using qualitative and quantitative techniques Develops qualitative models with real-time case studies

Radio Frequency Identification (RFID) Technology and Application in Fashion and Textile Supply Chain highlights the technology of Radio Frequency Identification (RFID) and its applications in fashion and textile manufacturing and supply chain management. It discusses the brief history, technology, and working of RFID including the types of RFID systems. It compares differences, advantages, and disadvantages of RFID and barcode technologies. It also covers application of RFID technology in textile and fashion manufacturing, supply chain, and retail, and RFID-based process control in textile and fashion manufacturing. It covers various applications of RFID starting from fibre manufacturing through yarn and fabric manufacturing; fabric chemical processing; garment manufacturing and quality control; and retail management. It offers case studies of RFID adoption by famous fashion brands detailing the competitive advantages and discusses various challenges faced and future directions of RFID technology.

Radio Frequency Identification (RFID) Technology and Application in Fashion and Textile Supply Chain highlights the technology of Radio Frequency Identification (RFID) and its applications in fashion and textile manufacturing and supply chain management. It discusses the brief history, technology, and working of RFID including the types of RFID systems. It compares differences, advantages, and disadvantages of RFID and barcode technologies. It also covers application of RFID technology in textile and fashion manufacturing, supply chain, and retail, and RFID-based process control in textile and fashion manufacturing. It covers various applications of RFID starting from fibre manufacturing through yarn and fabric manufacturing; fabric chemical processing; garment manufacturing and quality control; and retail management. It offers case studies of RFID adoption by famous fashion brands detailing the competitive advantages and discusses various challenges faced and future directions of RFID technology.

This book provides insight into the world of pharmaceutical quality systems and the key elements that must be in place to change the business and organizational dynamics from task-oriented procedure-based cultures to truly integrated quality business systems that are self-detecting and correcting. Chapter flow has been changed to adopt a quality systems organization approach, and supporting chapters have been updated based on current hot topics including the impact of the worldwide supply chain complexity and current regulatory trends. Key Features: Presents insight into the world of pharmaceutical quality systems Analyzes regulatory trends and expectations Includes approaches and practices used in the industry to comply with regulatory requirements Discusses recent worldwide supply chain issues Delivers valuable information to a worldwide audience regarding the current GMP practices in the industry