Now there's a single easy-reading reference to help you plan, implement, and audit a HACCP (Hazard Analysis and Critical Control Point) program. HACCP User's Manual provides comprehensive information on new and existing HACCP systems, current U.S. Food and Drug Administration (FDA) and U.S. Department of Agriculture (USDA) regulations, and procedures for application of the system, as well as sanitation standard operating procedures (SSOPs). With more than 30 years' experience in the food industry, Don Corlett is eminently qualified to guide you step-by-step through the process of tailoring and operating a HACCP system to fit your operation. In HACCP User's Manual, you find expert tips for getting started, details on how to develop and implement a HACCP plan, and how to operate the HACCP system, including organization of record-keeping techniques.

When a biological drug patent expires, alternative biosimilar products are developed. The development of biosimilar products is complicated and involves numerous considerations and steps. The assessment of biosimilarity and interchangeability is also complicated and difficult. Biosimilar Drug Product Development presents current issues for the development of biosimilars and gives detailed reviews of its various stages and contributing factors as well as relevant regulatory pathways and pre- and post-approval issues.

As innovation moves from the lab to the market, a new research phase begins for the entrepreneur: the market research phase. Inspired by a new technology that can change the world, critical questions need to be addressed. Is there a market for my innovation? Who are my clients? What do they need? Is my innovation filling that gap in the market? Who are my competitors? How are they approaching the market? If these questions are unaswered, entrepreneurs meet potential investors or partners with only a basic understanding of their market. The objective of this book is to fill this gap. It is a practical manual that gives entrepreneurs real-world advice and tools to build a solid market model. The book provides tips, models and tools entrepreneurs can use to collect, interpret and present their market and integrate it into their business plan. What the entrepreneur learns in this book will help him throughout his journey. After going over the market research process, he will learn how to design and use a number of market research tools, and how to adapt them in a life science context. From building a web survey to preparing interviews to doing your own secondary research, this handbook will help him gain a comprehensive understanding of how to perform his own market research activities and how to analyze his data. Finally, a number of frameworks (such as the TAM-SAM-SOM as well as the KANO Model) are described so that he can efficiently share what he has learned, using models that simply yet effectively shares findings.

International production networks in manufacturing, particularly in machinery industries, have rapidly developed over the last two decades, resulting in dramatic increases in intra-regional and intra-industry trade, providing a key source of regional growth, integration and development in East Asia. This book provides a better understanding on how to effectively further increase SME participation in East Asian production networks, and in doing so identifies key challenges and issues that they need to address. This book aims to not only fill the theory-practice gap, but also to lay solid foundations for designing national arrangements and a regional institutional frameworks to further encourage and support SME engagement and participation in regional and global production networks. The book contains several country case studies and by drawing upon individual country experiences, at various stages of economic development, this book demonstrates the varying difficulty faced by SMEs in ASEAN member countries attempting to participate in regional production networks and highlighting differences in needs and policy priorities. This book offers both a more focused theme on the assessment of globalization and a rather unique approach by focusing upon the particular importance of SMEs, and by utilizing micro-level data at the firm or plant level. Its policy insights and the richness and uniqueness of the empirical findings will make the book an invaluable contribution to understanding East Asian production networks.

This book is an everything-included approach to understanding drones, creating an organization around using unmanned aircraft, and outlining the process of safety to protect that program. It is the first-of-a-kind safety-focused text book for unmanned aircraft operations, providing the reader with a required understanding of hazard identification, risk analysis, mitigation, and promotion. It enables the reader to speak the same language as any civil aviation authority, and gives them the toolset to create a safety risk management program for unmanned aircraft. The main items in this book break down into three categories. The first approach is understanding how the drone landscape has evolved over the last 40 years. From understanding the military components of UAS to the standards and regulations evolution, the reader garners a keen understanding of where we came from and why it matters for moving forward. The second approach is in understanding how safety risk management in aviation can be applied to drones, and how that fits into the regulatory and legislative environment internationally. Lastly, a brief synopsis of the community landscape for unmanned aircraft is outlined with interviews from important leaders and stakeholders in the marketplace. Drones fills a gap in resources within the unmanned aircraft world. It provides a robust understanding of drones, while giving the tools necessary to apply for a certificate of authorization, enabling more advanced flight operations for any company, and developing safety risk management tools for students and career professionals. It will be a mainstay in all safety program courses and will be a required tool for any and all individuals looking to operate safely and successfully in the United States.

In this timely title Professor Arti Rai brings together a wide range of articles that reveal the important role of intellectual property law in the formation and development of the dynamic and economically significant biotechnology industry. The collection encompasses theoretical articles that present principles of patent economics important to the industry, articles that discuss the patent law doctrines most relevant to biotechnology and empirical studies on the 'real world' effects of patents and secrecy. These are resonant issues in an ever-expanding field, and will establish this book as an essential reference point for lawyers, researchers and students.

Nanostructures for Oral Medicine presents an up-to-date examination of the applications and effects of nanostructured materials in oral medicine, with each chapter addressing recent developments, specific applications, and uses of nanostructures in the oral administration of therapeutic agents in dentistry. The book also includes coverage of the biocompatibility of nanobiomaterials and their remarkable potential in improving human health and in reducing environmental pollution. Emerging advances, such as Dr. Franklin Tay's concept of a new nanotechnology process of growing extremely small, mineral-rich crystals and guiding them into the demineralized gaps between collagen fibers to prevent the aging and degradation of resin-dentin bonding is also discussed. This work will be of great value to those who work in oral medicine, providing them with a resource to gain a greater understanding of how nanotechnology can help them create more efficient, cost-effective products. In addition, it will be of great interest to those who work in materials science who wish to gain a greater appreciation of how nanostructured materials are applied in this field.

A comprehensive presentation of wicking models developed in academia and industry, Wicking in Porous Materials: Traditional and Modern Modeling Approaches contains some of the most important approaches and methods available, from the traditional Washburn-type models to the latest Lattice-Boltzmann approaches developed during the last few years. It provides a sound conceptual framework for learning the science behind different mathematical models while at the same time being aware of the practical issues of model validation as well as measurement of important properties and parameters associated with various models. Top experts in the field reveal the secrets of their wicking models. The chapters cover the following topics: Wetting and wettability Darcy's law for single- and multi-phase flows Traditional capillary models, such as the Washburn-equation based approaches Unsaturated-flow based methodologies (Richard's Equation) Sharp-front (plug-flow) type approaches using Darcy's law Pore network models for wicking after including various micro-scale fluid-flow phenomena Studying the effect of evaporation on wicking using pore network models Fractal-based methods Modeling methods based on mixture theory Lattice-Boltzmann method for modeling wicking in small scales Modeling wicking in swelling and non-rigid porous media This extensive look at the modeling of porous media compares various methods and treats traditional topics as well as modern technologies. It emphasizes experimental validation of modeling approaches as well as experimental determination of model parameters. Matching models to particular media, the book provides guidance on what models to use and how to use them.

The global pharmaceutical industry is currently estimated to be worth $1 trillion. Contributors chart the rise of scientific marketing within the industry from 1920-1980. This is the first comprehensive study into pharmaceutical marketing, demonstrating that many new techniques were actually developed in Europe before being exported to America.

This book presents decision support tools that can be used in the early design stage to analyze the feasibility of a product and its components for remanufacturing. It also covers how to design a product specifically for remanufacturing and offers supporting case studies. This is a comprehensive solutions guide for remanufacturing decision-making. The book illustrates an approach that can be used at the product End-of-Life (EOL) stage to generate optimized recovery plans for the returned products. Opportunities for Industry 4.0 to support remanufacturing along with case studies are included to showcase the decision-making tools. Remanufacturing and Remanufacturability Assessment for the Circular Economy: A Solutions Guide will be of interest to practitioners, business professionals, and researchers that work in the industrial and manufacturing sectors. Those involved with supply chain management and advanced technologies associated with Industry 4.0, sustainability, and integrated techniques of circular supply chains will also find this book very useful.

In 1300, women brewed and sold most of the ale drunk in England, but by 1600 the industry was largely controlled by men. Ale, Beer and Brewsters investigates this change, asking how, when, and why brewing ceased to be a woman's trade and became a trade of men. In doing so, Bennett sheds new light on a central problem in women's history: the effects of early capitalism on the status of women's work.

This new edition provides an alternative overview of 18th-century British economy. Recent macroeconomic history has discounted many of the achievements of the Industrial Revolution, but this text dissects the characteristics and processes of industry in the 18th century. A male industrial revolution has been presented as the general experience, but new industries, notably in textiles and metal products, were primarily employers of women. This work gives these industries and their workforce due prominence. Technologies, work processes, labour forces and markets shifted in a variety of directions and forms to create a sector of dynamic new initiatives alongside stable and declining crafts. The key to the Industrial Revolution lies in the sources of technological creativity and the structures of industrial communities. The rise of the factory system was one result. This text reasserts the primacy of the industrial experience to Britain's economic history.

Deep Stall applies a framework of strategic analysis to the Boeing Company. Boeing is the world's largest aerospace / defence company, with turnover in the region of US $60bn. The book examines the relative decline of Boeing in the civil aircraft market in relation to European manufacturer, Airbus. The aim of the book is to utilize the concept of strategic value to explain Boeing's decline. The authors define this concept as investment in people and technology to leverage future market success by developing innovative new products, arguing that Boeing has neglected strategic value in favour of shareholder value, defined in terms of short-term cash benefits. The rationale for the book exists both in the fact that the story in itself is interesting and also in the wider framework of analysis concerning the correct strategic approach for running a high technology business. The argument illustrates what can happen when quarterly returns become the predominant strategic rationale for a company. In the U.S. the business media (Economist, Forbes, Fortune, and Business Week etc) are now focusing on the question of Boeing's decline and the major implications for the U.S. national interest. Boeing is one of the jewels in the US technology crown, but today U.S. jobs and capability are being exported abroad, with most of its aircraft program work based in Asia. This is a hot topic in the US which explains why the business media are now so interested in this question. The book sits squarely in the centre of this debate. Deep Stall concludes with a brief analysis of the recent fight-back that has been evident in Boeing's fortunes and the successful campaign to sell the new 787. The authors probe the question of whether Airbus or Boeing is likely to dominate in the next ten or fifteen years.

The mood of the international grain market changed remarkably in the decade before this book was originally published in 1986. In the early 1970s, which were years of buoyancy and high prices, the concern was with feeding the starving millions and subsequently, in the United states, with the use of the grain embargo weapon to put pressure on the Soviet Union. In the mid-1980s, after a long period in which the recession kept prices down, the climate was much gloomier. The book considers the state of the major supplier countries and their particular problems. It charts the changes in the market and discusses major issues of international concern. It concludes by surveying prospects for the market.

This brand new volume in the ASM Handbook series has been developed to address the current and rapidly expanding importance of additive manufacturing (AM). ASM Handbook, Volume 24: Additive Manufacturing Processes provides the latest knowledge in materials, processes, and applications of AM, written by the leading experts in research and industry. It begins with an introduction and history of AM, authored by some of the key participants in that history as they trace the evolution of AM. The complete suite of materials and processes for polymers and ceramics are described in detail in the next two divisions. A division on metal AM processes begins with an in-depth description of the production and characterization of metal powders, which has a big effect on the success or failure of metal AM processes. The book describes AM processing of a wide variety of materials, illustrating differences in characteristics of metal alloys produced by AM processes in contrast to conventional processes. Volume 24 also covers direct-write processes, which take advantage of AM processes to combine materials and devices for multifunctional engineering applications.

Reliability Based Aircraft Maintenance Optimization and Applications presents flexible and cost-effective maintenance schedules for aircraft structures, particular in composite airframes. By applying an intelligent rating system, and the back-propagation network (BPN) method and FTA technique, a new approach was created to assist users in determining inspection intervals for new aircraft structures, especially in composite structures. This book also discusses the influence of Structure Health Monitoring (SHM) on scheduled maintenance. An integrated logic diagram establishes how to incorporate SHM into the current MSG-3 structural analysis that is based on four maintenance scenarios with gradual increasing maturity levels of SHM. The inspection intervals and the repair thresholds are adjusted according to different combinations of SHM tasks and scheduled maintenance. This book provides a practical means for aircraft manufacturers and operators to consider the feasibility of SHM by examining labor work reduction, structural reliability variation, and maintenance cost savings.

Coffee Culture: Local experiences, Global Connections explores coffee as (1) a major commodity that shapes the lives of millions of people; (2) a product with a dramatic history; (3) a beverage with multiple meanings and uses (energizer, comfort food, addiction, flavouring, and confection); (4) an inspiration for humor and cultural critique; (5) a crop that can help protect biodiversity yet also threaten the environment; (6) a health risk and a health food; and (7) a focus of alternative trade efforts. This book presents coffee as a commodity that ties the world together, from the coffee producers and pickers who tend the plantations in tropical nations, to the middlemen and processors, to the consumers who drink coffee without ever having to think about how the drink reached their hands.

This book examines how Progressive Labor (PL) insurgents challenged the International Ladies' Garment Workers Union (ILGWU) and tried to revolutionize labor in New York City's garment industry during the 1960s. Progressive Labor's role in New York City's economically important but declining garment industry -- the group's first attempt to organize industrial workers on the job -- suggests the problematic nature of PL's attempt to transform itself from a group of radical intellectuals into a mass working-class party. Pitted against powerful opponents, such as the garment firms and the imperious, socially progressive, and historically anticommunist ILGWU, a handful of PLers were able to foment a surprising number of work stoppages, which exposed the egregious problems facing low-paid black and Latino garment workers and their problematic relationship with the ILGWU. Progressive Labor's experience in New York City's garment industry suggests that industry workers were very willing to fight their trade union battles under communist leadership, but were far less willing to commit themselves to Progressive Labor's strategy for communist revolution.

The pharmaceutical industry has encountered major shifts in recent years, both within the industry, and in its external environment. The cost of healthcare rising due to an ageing population, the intensification of regulatory requirements and mergers within the industry have led to an increased need for restructuring, cost reduction and culture change projects. Project management is the key to addressing these needs, and also to effective drug development. Given the costs of development and the critical issue of 'time to market', project management techniques - appropriately used - are a key factor in bringing a drug to market. In this book, Laura Brown and Tony Grundy's pharmaceutical expertise and experience offers the reader a guide to the most relevant project management tools and techniques and how to rigorously apply them in the pharmaceutical industry. The authors cover the technical, strategic and human aspects of project management, including contingency planning, simulation techniques and different project options. Complete with decision-tree diagrams, checklists, exercises and a full glossary, Project Management for the Pharmaceutical Industry provides clinical research, drug development and quality assurance managers or directors with a one-stop reference for successfully managing pharmaceutical projects. The text has been revised for this edition and now includes some additional material on risk management.

Maritime trade is the backbone of the world's economy. Around ninety percent of all goods are transported by ship, and since World War II, shipbuilding has undergone major changes in response to new commercial pressures and opportunities. Early British dominance, for example, was later undermined in the 1950s by competition from the Japanese, who have since been overtaken by South Korea and, most recently, China. The case studies in this volume trace these and other important developments in the shipbuilding and ship repair industries, as well as workers' responses to these historic transformations.

How much does regulation matter in shaping corporate behavior? This pathbreaking, in-depth study of fourteen pulp manufacturing mills in the United States, Canada, Australia, and New Zealand reveals that steadily tightening regulatory standards have been crucial for raising environmental performance. But while all firms have shown improvement, some have improved more than others, many going substantially beyond compliance. What explains the variation in compliance? It's not necessarily the differences in regulation in each country. Rather, variation is accounted for by the complex interaction between tightening regulations and a social license to operate (especially pressures from community and environmental activists), economic constraints, and differences in corporate environmental management style. Shades of Green provides the most extensive and systematic empirical study to date of why firms achieve the levels of environmental performance that they do.

This book explores connections between activist debates about food sovereignty and academic debates about alternative food networks. The ethnographic case studies demonstrate how divergent histories and geographies of people-in-place open up or close off possibilities for alternative/sovereign food spaces, illustrating the globally uneven and varied development of industrial capitalist food networks and of everyday forms of subversion and accommodation. How, for example, do relations between alternative food networks and mainstream industrial capitalist food networks differ in places with contrasting histories of land appropriation, trade, governance and consumer identities to those in Europe and non-indigenous spaces of New Zealand or the United States? How do indigenous populations negotiate between maintaining a sense of moral connectedness to their agri- and acqua-cultural landscapes and subverting, or indeed appropriating, industrial capitalist approaches to food? By delving into the histories, geographies and everyday worlds of (post)colonial peoples, the book shows how colonial power relations of the past and present create more opportunities for some alternative producer-consumer and state-market-civil society relations than others.

An exploration of the Totonac native community of Papantla, Veracruz, during the last half of the eighteenth century. Told through the lens of violent revolt, this is the first book-length study devoted to Papantla during the colonial era. The book tells the story of a native community confronting significant disruption of its agricultural tradition, and the violence that change provoked. Papantlas story is told in the form of an investigation into the political, social, and ethnic experience of an agrarian community. The Bourbon monopolisation of tobacco in 1764 disturbed a fragile balance, and pushed long-term native frustrations to the point of violence. Through the stories of four uprisings, Jake Frederick examines the Totonacs increasingly difficult economic environment, their view of justice, and their political tactics. Riot! argues that for the native community of Papantla, the nature of colonial rule was, even in the waning decades of the colonial era, a process of negotiation rather than subjugation. The second half of the eighteenth century saw an increase in collective violence across the Spanish American colonies as communities reacted to the strains imposed by the various Bourbon reforms. Riot! provides a much needed exploration of what the colony-wide policy reforms of Bourbon Spain meant on the ground in rural communities in New Spain. The narrative of each uprising draws the reader into the crisis as it unfolds, providing an entree into an analysis of the event. The focus on the community provides a new understanding of the demographics of this rural community, including an account of the as yet unexamined black population of Papantla.

Few cars in history have grabbed the public's fancy as much as the ill-fated Edsel-the Titanic of automobiles, a marketing disaster whose magnitude has made it a household word. Remarkably, there has never before been a book that tells the whole story-how the Edsel was planned, created, produced, and marketed. This richly illustrated book is the result of years of research by an award-winning automotive historian with access to the dark reaches of the Ford Motor Company's archives. The author also interviewed most of the original key Edsel design team stylists, who have supplied additional archival material. The result is a unique history of the Edsel program from the initial discussions in the late 1940s, through the first sketches in the mid-1950s, to the last, unlamented 1960 models. The Edsel story, however, deals with much more than a new brand of car. It was a key component in a deadly serious corporate undertaking at Ford Motor Company following World War II. Ford wanted to remedy years of mismanagement and return the company to parity with General Motors by dramatically expanding Ford's presence in the burgeoning medium-priced field. The Edsel was the most spectacular failure in that effort, but was only one pawn in a complex, high-stakes chess game that was a thoroughgoing disaster from start to finish. In the case of the Edsel, the failure was the result of almost too many factors to count: poorly conceived marketing, contentious internal corporate politics, bad quality control, and, ultimately, lack of support at the higher reaches of the corporation. The greatest irony of all, though, is that the Edsel-as this book demonstrates in its surprising conclusion-was actually a modest success that deserved continued management support.

Weaving as a subject is an integral part of any textile engineering/technology program, the others being fibre manufacturing, yarn manufacturing and textile chemical processing. This book amalgamates both the compartments (preparatory processes and the loom mechanism) of weaving technology and presents a holistic picture. The machine descriptions are presented from the viewpoint of principles and no attempt has been made to make them exhaustive by incorporating various models or variants. The mathematical relations among various parameters have been derived starting from the first principles and each chapter concludes with solved numerical examples.