Knowing how to deal with the regulatory issues, understanding the impacts of cleanliness, and recognizing the affect that poor facility layout will have on GMP spaces are only some of the issues an experienced Project Manager must focus on. Completely revised and updated, Sterile Product Facility Design and Project Management, Second Edition provides comprehensive guidance on how to develop and execute biotech and other sterile drug facilities based on current industry best practices. Each chapter highlights a specific issue centered on managing biotech facilities projects in a GMP environment. The author uses real-world examples of common industry practice to lead you through the idiosyncrasies of a biotech project in an effort to answer some of the more common, and often perplexing, questions that can stand in the way of success. You get a mini seminar on each topic covered. Breaking the project life-cycle into four phases, the text takes you through each phase from the Project Manager's viewpoint. Unlike other books that cover design, technology, and validation in general terms, this book addresses the industry specific issues that make biotech facilities so costly and difficult to deliver. It puts the pieces of the puzzle together in a manner that increases your opportunity for success.

Sponsor companies and CROs alike will appreciate the industry-wide analysis, practical, how-to advice, and helpful charts and checklists provided by Outsourcing in Clinical Drug Development. A panel of experts discuss supplier identification and selection, financial considerations, and the ethical issues. They cover contracting out laboratory analysis, data management, and statistical services, and the effects of outsourcing on quality assurance. Whether readers are beginning to explore the possibility of outsourcing or already involved in long-term strategic outsourcing partnerships, this invaluable resource is a complete guide to the drug development outsourcing relationship.

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!

This book addresses the question of how competition takes place in international manufacturing industries. It examines patterns of rivalry among firms from different countries across national boundaries and their influences on international trade and investment. By using various data on Japanese firms in manufacturing industries from the late 1950s through the early 2000s, the first part of this book presents a series of empirical analyses that examines effects of market structure on export pricing, linkages of domestic and foreign market structures on trade performance, and patterns of oligopolistic interactions among firms from different countries in exporting. The second part of this book deals with the impact of strategic interactions on foreign direct investment. In particular, the book examines 'bunching' in foreign direct investment, strategic interactions in intra-industry cross-market foreign direct investment, and their effects on entry patterns and post-entry performance.

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.

In 1926, the Carriage Builders' National Association met for the last time, signaling the automobile's final triumph over the horse-drawn carriage. Only a decade earlier, carriages and wagons were still a common sight on every Main Street in America. In the previous century, carriage-building had been one of the largest and most dynamic industries in the country. In this sweeping study of a forgotten trade, Thomas A. Kinney extends our understanding of nineteenth-century American industrialization far beyond the steel mill and railroad. The legendary Studebaker Brothers Manufacturing Company in 1880 produced a hundred wagons a day--one every six minutes. Across the country, smaller factories fashioned vast quantities of buggies, farm wagons, and luxury carriages. Today, if we think of carriage and wagon at all, we assume it merely foreshadowed the automobile industry. Yet., the carriage industry epitomized a batch-work approach to production that flourished for decades. Contradicting the model of industrial development in which hand tools, small firms, and individual craftsmanship simply gave way to mechanized factories, the carriage industry successfully employed small-scale business and manufacturing practices throughout its history.

"The Carriage Trade" traces the rise and fall of this heterogeneous industry, from the pre-industrial shop system to the coming of the automobile, using as case studies Studebaker, the New York-based luxury carriage-maker Brewsters, and dozens of smallerfirms from around the country. Kinney also explores the experiences of the carriage and wagon worker over the life of the industry. Deeply researched and strikingly original, this study contributes a vivid chapter to the story of America's industrial revolution.

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.

The overall aim of this work is to provide a reference book which describes the general framework for conducting GCP-compliant clinical research, particularly pharmaceutical industry clinical research. Wendy Bohaychuk and Graham Ball run a consultancy, GCRP Ltd., which has conducted over 820 GCP audits involving more than 200 companies in the last 10 years. More than 5,000 individuals have been involved in their training courses to help people perform GCP-compliant clinical research. They have authored several books and articles including:

• Standard operating procedures for investigators
• Standard operating procedures for sponsors and CROs
• GCP — an indexed reference

Drawing on their wealth of experience, they have produced this enlightening and practical reference work which fills an educational gap in the understanding of GCP at all levels. Written in concise language simple enough to be accessible to those new in the field, the dozens of real-life stories and detailed case studies at the end of each chapter make the book an invaluable resource for the more experienced, highlighting what can go wrong in a clinical study: A study of prostate cancer in the UK - An investigator brochure was not provided. The company argued that a brochure was unnecessary because the drug was already marketed. Indeed it was — for hypertension! A study of cardiovascular surgery in the UK - The consent dates were changed (by overwriting) to indicate that the patients had provided consent before the study started. The original dates post-dated the start of the study. A study of hypertension in Germany - The investigator brochure predated the study by nine years! Checklists are provided throughout the book to help monitors, auditors and investigators ensure that nothing important is overlooked. The authors present the topic of GCP with remarkable clarity, insight and enthusiasm emphasizing that this code of practice was not designed to make studies more difficult for investigators or more expensive for sponsors and CROs but, in the final analysis, to ensure the safety and well-being of study participants and future patients who will benefit from well-conducted, GCP-compliant studies.

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

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 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.

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.

This contributed volume collects insights from industry professionals, policy makers and researchers on new and profitable business models in the field of electric vehicles (EV) for the mass market. This book includes approaches that address the optimization of total cost of ownership. Moreover, it presents alternative models of ownership, financing and leasing. The editors present state-of-the-art insights from international experts, including real-world case studies. The volume has been edited in the framework of the International Energy Agency's Implementing Agreement for Cooperation on Hybrid and Electric Vehicles (IA-HEV). The target audience primarily comprises practitioners and decision makers but the book may also be beneficial for research experts and graduate students.

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.

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.

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.

This book aims to privde a detailed survey and analysis of the most important issues in biotechnology in the Soviet Union's successor states as they each attempt to make their own painful transitions to a market economy. It examines both the impact of this branch of science on the economy as a whole and the management of biotechnology research and development (R & D) as well as production. Emphasis is placed on the alternative structures which have emerged during the transitional process. Detailed information is also provided on biotechnology research projects, joint ventures, institutes, and factories.

For the area specialist, the book is rich in useful data and analysis while its structure facilitates its use as a handbook by business people in the West and scientists looking for specific information on biotechnology in the former USSR. It will provide those with a more practical orientation with a realistic appraisal of biotechnology in the Eurasian area and some of the problems it faces.

Research in the pharmaceutical industry today is in many respects quite different from what it used to be only fifteen years ago. There have been dramatic changes in approaches for identifying new chemical entities with a desired biological activity. While chemical modification of existing leads was the most important approach in the 1970s and 1980s, high-throughput screening and structure-based design are now major players among a multitude of methods used in drug discov ery. Quite often, companies favor one of these relatively new approaches over the other, e.g., screening over rational design, or vice versa, but we believe that an intelligent and concerted use of several or all methods currently available to drug discovery will be more successful in the medium term. What has changed most significantly in the past few years is the time available for identifying new chemical entities. Because of the high costs of drug discovery projects, pressure for maximum success in the shortest possible time is higher than ever. In addition, the multidisciplinary character of the field is much more pronounced today than it used to be. As a consequence, researchers and project managers in the pharmaceutical industry should have a solid knowledge of the more important methods available to drug discovery, because it is the rapidly and intelligently combined use of these which will determine the success or failure of preclinical projects.