Error-proofing in the production process of pharmaceuticals isn't just a matter of good business, it has life-and-death implications for consumers. To that end, the 2013 Drug Quality and Security Act in large part requires new mandates on tracking and tracing chain of custody in the supply chain. Pharmaceutical Supply Chain: Drug Quality and Security Act overviews the new mandate and its implications, including implementation strategies for track-and-trace programs along with presenting a fuller understanding of the mechanics of intergovernmental policies and oversights. The book focuses on the delicate balance between protecting the public through legislation against negligent compounding pharmacies and protecting patients by assuring a supply of needed compounded drugs by not over-regulating the industry. The author discusses lessons learned from the earlier e-pedigree initiatives, the technology advances that enable supply chain security, and how the industry will need to respond to the myriad of threats facing the pharmaceutical drug supply chain and comply with this act. He goes in depth into each segment of the pharmaceutical drug supply chain, describing the industry segment and how it will need to adapt to the new act. By incorporating real-world examples of industry leaders, the book underlines the contributions of individuals who have made a difference through innovations and execution. It also addresses how laws are made, and specifically how the Drug Quality and Security Act was passed by Congress and signed into law. In an industry that is so big, you may feel that you cannot make a difference. This book provides you with key insights on how the forward supply chain process should work and how anyone can make a difference at all levels.

Drying processes are among the most energy-consuming operations in industry. Flame spray drying (FSD) is a novel approach to reduce the energy supply needed for the spray drying process. Flame Spray Drying: Equipment, Mechanism, and Perspectives describes FSD technology and current developments in flame techniques and evaluates potential industrial implementation. Details advantages of FSD in terms of energy consumption and reduced drying time Promotes applications of biofuels for the drying process Analyzes the FSD method from CFD modelling to product quality Evaluates potential safety and product degradation risks Provides examples of potential applications of the FSD technique in drying of different materials This book describes an important new technique that is useful to chemical and process engineering researchers, professionals, and students working with drying technologies.

1) This is a comprehensive volume on India's Industrial Policy and Performance. 2) The book is rich in empirical data and policy analysis. 3) This book will be of interest to departments of development studies and political economy across UK and USA.

Presents a comparison between conventional and advanced manufacturing methods of FGM fabrication Discusses the fundamentals and advancements of FGMs Offers case studies from labs all over the world by key research groups Covers the entire concept of recent trends and advancements in the manufacturing of FGMs via different techniques Includes the principles and working details of various processing techniques and limitations

Building on his decades of experience as a consultant and project manager in the automotive industry, the author develops comprehensive and pragmatic recommendations for action regarding the digital transformation of the automotive and supplier industries. At the heart is the transition from a vehicle-focused to a mobility-oriented business model. Based on the catalysts of the digital change, four digitizsation fields are structured, and a roadmap for their transformation is presented. The topics of comprehensive change in corporate culture and an agile and efficient information technology are covered in detail as vital success factors. Selected practical examples of innovative digitizsation projects provide additional ideas and impulses. An outlook on the automotive industry in the year 2040 completes the discourse.

In this book, author Nate Furuta, former chair and CEO of Toyota Boshoku America Inc., shares the story of his decades of experience directly leading the establishment of Toyota cultures outside Japan. Furuta was the first Toyota employee on the ground at New United Motor Manufacturing Inc. (NUMMI), Toyota's joint venture in California with General Motors, where he directly led the establishment of the most revolutionary labor-management agreement in the history of the US auto industry. In addition, Furuta was the first Toyota employee on the ground in Georgetown Kentucky at Toyota's first full-scale, wholly owned manufacturing operation outside Japan, where he led (working directly with President Fujio Cho) the establishment of Toyota's general management systems and culture there. This book tells the stories of establishing successful operations in those two iconic organizations as well as others. Furuta reveals details, both stories and process descriptions that only he can tell. He takes you along as he and others lead Toyota's intense globalization from the early 1980s to recent days. He introduces you to the critical leaders in Toyota's history, such as Taiichi Ohno and Fujio Cho as well as Kenzo Tamai, the head of the company's HRM function in the 1980s. This book is not about human-resource management (HRM) policies and procedures. It provides a deep dive into the way senior leaders embody deep awareness of HRM matters, developing and executing company strategy while at the same time developing organizational capability. The role of senior leaders isn't just a matter of directing the company to achieve objectives; it is a matter of building the capability to achieve those objectives, consistently, and further developing capability as it executes. Key to this is to develop the awareness, attitude, capability, and practice of identifying problems as progress is made toward achieving objectives, which is, in fact, attained through steadily eliminating each problem as it arises. This becomes a self-reinforcing loop of the organization, tapping in to the essence of solving problems while simultaneously developing ever better problem-solving skills and better problem solvers. This loop propels an organization toward meeting its purpose while developing capability for capability development. Essentially, this book reveals Toyota's general management systems from the firsthand experience of a Toyota Japanese senior manager and describes, with stories and process examples, the attitude, behaviors, and systems needed to successfully establish and lead in a true Lean business environment.

While there are those who say manufacturing is dying, it is not and will not. Without a universal vow of poverty, growing economies will only increase demand. Manufacturing in the 21st century is not a question of if -- Rather, it is a function of why, what, who, where, and how. The nature and pace of change in those factors are overwhelming many. Fear, futile resistance, and uncertainty are common. While manufacturing will not die, individual manufacturing companies will if they do not learn to thrive in this new world. This book is a dynamic guide for manufacturing leaders who want to reduce the ambiguity and overwhelming changes and develop a realistic, progressive, and responsive thinking process that enables success. It provides a business operating system framework that is the foundation for connecting the many pieces of a manufacturing business into an effective, profitable operation. The author walks through the elements, relationships, capabilities, and mutability 21st-century manufacturing requires. Executives of manufacturing companies will be better able to think about and execute viable strategies leveraging the changing economy. Essentially, manufacturing is becoming increasingly complex, as are business and socioeconomic and political realities. Rapidly evolving technology adds to the confusing environment that precludes "more of the same, better, faster and cheaper" as a workable business strategy. The tsunami of information hitting owners and leaders is overwhelming many, and it is easy to become frozen in place. Economic growth and improving standards of living require that all of this change be broken into bite-size understandable pieces that thaw the minds of executives, allowing them to assess what is best right now, and move forward. This book does not overwhelm with details and models; rather it provides thinking and examples in small chunks that enable manufacturers to develop and master skills for high-level strategic leadership in ambiguity.

Focuses on blow room sequence of machines and its functioning. Discusses role of electronics in management of various controls. Reviews practical perspective of modern techniques used in processing cotton through blow room. Offers an exclusive chapter on modern blow room concept. Includes solved examples and exercises.

This book contains the most current information on how to implement, develop and maintain an effective Corrective Action and Preventive Action (CAPA) and investigation program using a 9-step closed-loop process approach for medical device, pharmaceutical and biologic manufacturers, as well as any company or institution, which has to maintain a quality system. CAPA violations along with ineffective complaint investigations continue to be the number one cited violation of device warning letters for the past four years, leading the US Food and Drug Administration or FDA to remind firms to fully investigate complaints, find the root cause of nonconforming products and document their CAPA activities. A review of FDA warning letters issued to pharmaceutical companies reveals that most of these warning letters resulted from recurring failures, ineffective investigations found, and missing or inappropriate corrective and preventive actions. Companies often make the mistake of fixing problems in their processes by revising procedures or more commonly by 'retraining' employees that may or may not have caused the problem. This is typically event-focused. Companies then will make the false assumption that the errors have been eradicated. In many cases they will also consider the steps taken as their Preventive Action. The reality is that the causes of the failure were never actually determined; therefore the same problem will recur over and over. CAPA is a complete system that collects information regarding existing and potential quality problems. It analyzes and investigates the issues to identify the root cause of nonconformities. CAPA is not just a quick-fix, simple approach. It is a process and has to be understood throughout organizations. This book addresses all of the above issues, in a pragmatic, down- to-earth manner.

This text identifies and discusses different technology innovation initiatives (TIIs) such as entrepreneurial capability, technology infrastructure capability, organizational culture and climate, and government initiatives. It further evaluates the relationship between various technology innovation initiatives and manufacturing performances using multi-criteria decision-making techniques such as fuzzy set theory (FST), structural equation modeling (SEM), and analytic hierarchy process (AHP). It will serve as an ideal reference text for graduate students and academic researchers in the field of industrial engineering, manufacturing engineering, mechanical engineering, automotive engineering. This book: * Discusses technology innovation initiatives such as entrepreneurial capability, technology infrastructure capability, and organizational culture. * Highlights technology innovation-strategy model in assisting manufacturing industries for enhancing their performance in today's competitive environment. * Examines the effect of technology innovation initiatives on the performance of manufacturing industries. * Covers multi-criteria decision-making techniques such as fuzzy set theory, structural equation modeling, and analytic hierarchy process. * Explores the validation of fuzzy-based technology innovation model through structural equation modeling.

This book will interest practitioners and researchers in the food science and nutrition fields, and possibly others with an interest in the interaction between diet and health. There have been considerable advances in scientific techniques in the last few decades and these have been used to examine the composition and applications of traditional cures. Modern science has also seen the investigation of herbs, spices and botanicals beyond their traditional usage. The evidence-based approach that the Editors propose is relatively rare for this type of topic.

Drawing on anthropology, historical sociology and social-epidemiology, this multidisciplinary book investigates how pharmaceuticals are produced, distributed, prescribed, (and) consumed, and regulated in order to construct a comprehensive understanding of the issues that drive (medicine) pharmaceutical markets in the Global South today. Based on primary research conducted in Benin and Ghana, and additional data collected in Cambodia and the Ivory Coast, this volume uses artemisinin-based combination therapies (ACTs) against malaria as a central case study. It highlights the influence of the countries colonial and post-colonial history on their models for state regulation, production, and distribution, explores the determining role transnational actors as well as industries from the North but also and increasingly from the South play in influencing local pharmaceutical markets and looks at the behaviour of health care professionals and individuals. Stepping back, the authors then unpick the pharmaceuticalization process and the multiple regulations at stake by looking at the workings of, and linkages between, (biomedical health) pharmaceutical systems, (representatives of companies) industries, actors in private distribution, and consumer practices. Providing a thorough comparative analysis of the advantages and disadvantages of different pharmaceutical systems, it is an important contribution to the literature on pharmaceutalization and the governance of medication. It is of interest to students, researchers and policy-makers interested in medical anthropology, the sociology of health and illness, global health, healthcare management and pharmacy. The Open Access version of this book, available at http://www.taylorfrancis.com/books/9780429329517, has been made available under a Creative Commons Attribution-Non Commercial-No Derivatives 4.0 license.

The history of patent harmonization is a story of dynamic actors, whose interactions with established structures shaped the patent regime. From the inception of the trade regime to include intellectual property (IP) rights to the present, this book documents the role of different sets of actors - states, transnational business corporations, or civil society groups - and their influence on the structures - such as national and international agreements, organizations, and private entities - that have caused changes to healthcare and access to medication. Presenting the debates over patents, trade, and the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement), as it galvanized non-state and nonbusiness actors, the book highlights how an alternative framing and understanding of pharmaceutical patent rights emerged: as a public issue, instead of a trade or IP issue. The book thus offers an important analysis of the legal and political dynamics through which the contest for access to lifesaving medication has been, and will continue to be, fought. In addition to academics working in the areas of international law, development, and public health, this book will also be of interest to policy makers, state actors, and others with relevant concerns working in nongovernmental and international organizations.

Since 2008, while the global automotive manufacturing has been faltering, the Chinese auto industry has been swiftly transformed into the largest producer in the world. The growth of the Chinese automakers is a close reflection of China's powerful manufacturing economy, and Geely Auto is one such best example. This book closely examines the rise of Geely as a privately-owned automaker in China. From its humble beginning as a refrigerator component maker and motorcycle manufacturer in the late twentieth century, Geely has grown to become not only a top selling national brand in China, the largest auto market in the world, but also a significant player in the global automotive industry. The book studies Geely's successful acquisition of Volvo, within a long-term framework of asset-seeking foreign direct investment, and then further investigates its recent strategic initiatives with Daimler, London Taxi, PROTON and Lotus. The book reveals how the little-known carmaker is worth close examination, via its product development, organizational dynamics, corporate culture, brand development, talent and cross-cultural management strategies, as well as the entrepreneurship of its visionary founder Shufu Li. From catching up in technology to a leader in product, service and business model innovations, Geely has driven out as a new Chinese automaker on the world stage. Facing challenges in clean energy and Internet of Things, artificial intelligence, new user's experience towards smart and mobility solution, Geely will continue to play an increasingly important role in the globalization age of the twenty-first century.

Aircraft Structures for Engineering Students, Seventh Edition, is the leading self-contained aircraft structures course text suitable for one or more semesters. It covers all fundamental subjects, including elasticity, structural analysis, airworthiness and aeroelasticity. Now in its seventh edition, the author has continued to expand the book's coverage of analysis and design of composite materials for use in aircraft and has added more real-world and design-based examples, along with new end-of-chapter problems of varying complexity.

This book is an invaluable introduction to the physical properties of foods and the physics involved in food processing. It provides descriptions and data that are needed for selecting the most appropriate equipment in food technology and for making food processing calculations.

This important collection presents in two volumes the most significant papers on the history of mass production and highlights crucial debates in the attempt to understand the phenomenon and its social and economic effects. The selection focuses on six important themes. Volume I opens with an exploration of the antecedents to mass production and an investigation of the mechanical, economic and social roots of the transformation in production methods at the beginning of the 20th century. The following section examines the emergence of 'Fordism' and the fundamental elements of the new system. The final section describes the extent to which mass production has spread through the wider economy and the ways in which it has changed in the process. In Volume II, the first section covers the impact of mass production on work and the workers. The second section looks at how Japan has exploited the principles of mass production and may indeed have evolved a new form of productive organisation. The concluding section raises the question of whether in the late 20th century the dominance of mass production is in decline.

Outbreaks of Mad Cow Disease, reports of potentially harmful genetically engineered corn and irradiated vegetables are fueling consumers' demands for clear, concise information about the safety and quality of the food supply. Librarians and consumers alike can quickly locate authoritative sources of up-to-date and accurate information in this easy to use handbook. There is a brief history of food safety with a chronology of incidents, products, and legislation. Recommended books, pamphlets, articles, Web sites, and other electronic resources are described. This one-stop handbook brings together in one volume food safety statistics, laws and regulations, and contact information for hot lines and help lines, organizations, and education and training opportunities. This book includes

An Overview of Food Safety

Issues in Food Safety

Chronology of Food Safety-related events

Food Safety Regulation

Food Safety Statistics

Careers in Food Safety

Food Safety Resources

Glossary DEGREESR"

Where presidents or members of affluent families were previously seen, it is increasingly the case that car manufacturers are owned by banks and investment funds which have taken control of the entire economic life of these firms. This has significant impact on the terms of employment and layoffs, wages and precarious work, growing inequalities in income strata, compensation levels for executives, and the implementation of short-termist strategies across business operations. This book explores this increasing financialisation - the predominance of the financial sector over the productive sector - in the automotive industry. In particular it is shown that the financial operations of these companies through leasing, insurance, loans and other financial instruments is now much more profitable than the manufacturing aspects of the business, which was originally the raison d'etre for these fi rms. The chapters demonstrate how there are great demands to increase the return to shareholders as a main concern, despite other metrics and/ or other stakeholders. The work studies the impact of financialisation at the world's five largest automakers which together represent almost 50% of car production, providing an exploratory analysis of profitability, shareholder composition, compensation to executives, workers' salaries, dividend payments to shareholders and employment. Encouraging debate on contemporary economy, this book marks a significant addition to the literature on financialisation, contemporary forms of capitalism, labour and economic sociology more broadly.

Many economically developing countries and nations without robust occupational hygiene (OH) educational programs endure a shortage of qualified occupational hygienists, resulting in higher rates of workplace injury, illness, and fatality. Damage to valuable infrastructure, environment, and public health also occurs without adequate support. Improving Global Worker Health and Safety Through Collaborative Capacity Building Initiatives outlines a broad variety of capacity building projects in OH. It also introduces detailed experiences of occupational hygienists working abroad and working on special global topics including a discussion of how global trade agreements influence the practice and policy within OH. It describes the special needs of informal workers who do not have a "typical" employer and special challenges of creating university curricular guidelines for OH, building competency, and increasing capacity. This book also informs experienced professionals in international OH-capacity building initiatives and directions. Features: Presents the global impact and importance of occupational hygienists Outlines knowledge and collaboration through networking Provides case studies on real world situations and problems This text will be useful for professionals and graduate students in the fields of occupational health and safety and public health.

Like its predecessors, the new and updated edition of Advanced Nutrition: Macronutrients, Micronutrients, and Metabolism is an essential textbook for advanced undergraduate and first-year graduate students studying human nutrition. This book draws on inter-related sciences including biochemistry, genetics, and physiology to provide a full understanding of nutrition science. This third edition describes the chemistry, absorption, use and excretion of each of the essential nutrients. There is comprehensive coverage of nutrient-nutrient interactions and both macro and micronutrients. The book places strong emphasis on how nutrient-genetic interactions function with respect to disease development. The new edition includes some of the most recent descriptions of the roles nutrients play in the expression of genetic traits for a variety of degenerative diseases. It includes a new chapter explains the function of microorganisms in the maintenance and development of chronic degenerative disease. Features: Chapters address clinical conditions such as obesity, starvation, hyperlipemia, renal disease and organ function. Includes updated information on the body's microbiotica and the daily nutrient needs of humans across the life cycle. Material reveals the neurodegenerative response to dietary variables with respect to the regulation of food intake. Chapter summaries highlight key information and case studies challenge students to integrate what they have learned to solve clinical cases.

This book highlights key ideas and factors to coach and guide professionals involved in learning about Sterile Manufacturing and operational requirements. It covers regulations and guidelines instituted by the FDA, ISPE, EMA, MHRA, and ICH, emphasizing good manufacturing practice and inspection requirements in the manufacturing of medicinal products. Additionally, this book provides the fundamentals of aseptic techniques, quality by design, risk assessment, and management in support of sterile operations applications. It creates a link to the implementation of business practices in drug manufacturing and healthcare and forms a correlation between design strategies including a step-by-step process to ensure reliability, safety, and efficacy of healthcare products for human and animal use. The book also provides a connection between drug production and regulated applications by offering a review of the basic elements of sterile processing, and how to remain viable with solid strategic planning. The book is a concise reference for professionals and learners in the field of sterile operations that governs primarily, pharmaceutical and medical device space, but can also extend to food and cosmetics that require clean (aseptic) manufacturing applications. It also helps compounding pharmacists and GMP inspectors and auditors.

From consumer boycotts and buycotts to social movement campaigns, examples of individual and collective actors forging political struggles on markets are manifold. The clothing market has been a privileged site for such contention, with global clothing brands and retailers being targets of consumer mobilization for the past 20 years. Labels and product lines now attest for the ethical quality of clothes, which has, in turn, given rise to ethical fashion. The Fight for Ethical Fashion unveils the actors and processes that have driven this market transformation through a detailed study of the Europe-wide coordinated campaign on workers' rights in the global textile industry - the Clean Clothes Campaign. Drawing on insights from qualitative fieldwork using a wide range of empirical sources, Philip Balsiger traces the emergence of this campaign back to the rise of 'consumer campaigns' and shows how tactics were adapted to market contexts in order to have retailers adopt and monitor codes of conduct. By comparing the interactions between campaigners and their corporate targets in Switzerland and France (two countries with a very different history of consumer mobilization for political issues), this ground-breaking book also reveals how one campaign can provoke contrasting reactions and forms of market change.

Freeze Drying of Pharmaceutical Products provides an overview of the most recent and cutting-edge developments and technologies in the field, focusing on formulation developments and process monitoring and considering new technologies for process development. This book contains case studies from freeze dryer manufacturers and pharmaceutical companies for readers in industry and academia. It was contributed to by lyophilization experts to create a detailed analysis of the subject matter, organically presenting recent advancements in freeze-drying research and technology. It discusses formulation design, process optimization and control, new PAT-monitoring tools, multivariate image analysis, process scale-down and development using small-scale freeze-dryers, use of CFD for equipment design, and development of continuous processes. This book is for industry professionals, including chemical engineers and pharmaceutical scientists.