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A History of a cGMP Medical Event Investigation
by Michael A. BrownCase study details the right way and the wrong way to successfully develop and market a new drugBeginning with the untimely death of a young mother, A History of a cGMP Medical Event Investigation unfolds a fictitious case study that captures how unchecked human flaws during the development and launch of a new drug can lead to disastrous consequences. Moreover, it illustrates how and why Six Sigma principles and methods should be applied to fully comply with FDA regulations at every stage of drug development and commercialization.From initial transgenic mouse studies to the FDA fatality investigation, this case study introduces all the key regulations and practices that govern the development, manufacture, and marketing of a new drug, including:FDA Investigational and New Drug Application ProcessesFDA Code of Federal Regulations' current Good Manufacturing Practice (cGMP)ISPE Good Automated Manufacturing Practice (GAMP)Readers will also be introduced to a variety of managers and researchers whose personal agendas conflict with best practices and therefore compromise the safety and effectiveness of a new drug product. Throughout the case study, the author offers tested and proven practices and tips so that these human flaws are not translated into drug product flaws. These practices and tips are critical and typically can only be learned through years of experience working in competitive drug development environments.A History of a cGMP Medical Event Investigation is ideal for students in biotechnology, pharmacology, engineering, and business management as well as professionals in biomedical and drug development. All readers will discover what can go wrong in developing and bringing a new drug to market. Most importantly, they will also learn how to apply Six Sigma principles and methods to ensure safe and effective product design, development, and manufacturing.
A History of the Andover Ironworks: Come Penny, Go Pound
by Kevin W. WrightSoon after Philadelphia began to exploit New Jersey's largest hematite deposit in 1758, Andover Furnace and Forge began producing the best metal in the world. Its product was so desirable that the newly formed American military wrested control from Loyalist owners in 1778. This frontier industrial outpost endured thirty-five years before labor costs, competition from cheap imports, careless consumption of woodlands and difficulty in transporting its products finally extinguished its fires. Today, repurposed eighteenth-century stone mills and mansions at Andover and Waterloo testify to the combination of rich ore, abundant water power and seemingly endless forests that long ago attracted teamsters, woodcutters, charcoal burners, miners, molders and smelters to the Appalachian Highlands of New Jersey. Local expert Kevin Wright tells the hidden story of the facets and personalities that once made Andover iron so widely coveted.
A History of the Future: Prophets of Progress from H. G. Wells to Isaac Asimov
by Peter J. BowlerIn this wide-ranging survey, Peter J. Bowler explores the phenomenon of futurology: predictions about the future development and impact of science and technology on society and culture in the twentieth century. Utilising science fiction, popular science literature and the novels of the literary elite, Bowler highlights contested responses to the potential for revolutionary social change brought about by real and imagined scientific innovations. Charting the effect of social and military developments on attitudes towards innovation in Europe and America, Bowler shows how conflict between the enthusiasm of technocrats and the pessimism of their critics was presented to the public in books, magazines and exhibitions, and on the radio and television. A series of case studies reveals the impact of technologies such as radio, aviation, space exploration and genetics, exploring rivalries between innovators and the often unexpected outcome of their efforts to produce mechanisms and machines that could change the world.
A History of the Italian Space Adventure: Pioneers and Achievements from the XIVth Century to the Present
by Giovanni CapraraThis well-documented and fascinating book tells how, over the centuries, a series of visionaries, scientists, technologists, and politicians fostered the involvement of Italy in space exploration. The lives of these pioneers was often far from easy, yet they persevered. The fruits of their efforts can today be witnessed in Italy’s success within the cutting-edge space sector. Italy’s history in space started at the end of the fourteenth century and continued with the development of fireworks. Later, the nineteenth century marked the beginning of research into rockets in a more scientific way. After World War II, rocket technology was advanced with the aid of German scientists, and in the 1960s Luigi Broglio, the father of Italian space exploration, designed the San Marco satellite. In 1979 the first Italian Space Plan was launched, but it was the foundation of the Italian Space Agency in 1988 that kick-started a program of exploration in various fields of cosmic research. The outcome was construction of the Vega launcher and collaboration in the International Space Station. Now the Italian space industry stands ready to play an important role in the Gateway orbital station. All of this history, and more, is explored in this riveting book.
A History of the Modern Chinese Navy, 1840–2020 (Routledge Studies in the Modern History of Asia)
by Bruce A. EllemanThis book provides a comprehensive history of the modern Chinese navy from 1840 to the present. Beginning with a survey of naval developments in earlier imperial times, the book goes on to show how China has since the mid-19th century four times built or rebuilt its navy: after the Opium Wars, a navy which was sunk or captured by the Japanese in the war of 1894–1895; during the 1920s and 1930s, a navy again sunk or lost to Japan, in the war of 1937–1945; in the 1950s, a navy built with Soviet help, which stagnated following the Sino-Soviet split in the early 1960s; and finally the present navy which absorbed its predecessor, but with the most modern sections dating from the 1990s—a navy which continues to grow and prosper. The book also shows how the underlying strategic imperative for the Chinese navy has been the defense of China’s coasts and major rivers; how naval mutiny was a key factor in the overthrow of the Qing and the Nationalist regimes; and how successive Chinese governments, aware of the potent threat of naval mutiny, have restricted the growth, independence, and capabilities of the navy. Overall, the book provides—at a time when many people in the West view China and its navy as a threat—a rich, detailed, and realistic assessment of the true nature of the Chinese navy and the contemporary factors that affect its development.
A History of the Office and Office Work: From Castle to Condominium
by Rob HarrisThis book brings together the office and office working as an economic construct, as a business function, as a building type and as a mode of work. It explores social and economic relations, and it traces the evolution of work and the environment and equipment needed to support it over the last 400 years. In so doing, it helps to fill a void in popular understanding of the office.The role of the office has been examined over the past three years in ways that it has never been examined before. Whilst the existential crisis arising from COVID-19 has settled somewhat, there remain big questions over the future of office workers and office real estate. This book is a timely, well-researched and fascinating contribution to the debate.Rob Harris explores how the nature of work has changed, and continues to change, placing the events surrounding COVID-19 into a longer-term perspective and asking what is the future of the office? Will it go through a radical reinvention? How will office work evolve in the future? Whither office buildings? The book emphasises the continuum of change and that today’s events are simply the latest stage of change, rather than something entirely novel.This book will be of interest to anyone with a stake in the built environment, whether as an investor, occupier, owner, manager or advisor. It is equally accessible to those with a non-technical background, including students on courses such as economic history, economics, geography, real estate and urban planning.
A History of the Railroad in 100 Maps
by Jeremy BlackThe first international history of railroads and railroad infrastructure told through stunningly reproduced maps. Since their origins in eighteenth-century England, railroads have spread across the globe, changing everything in their path, from where and how people grew and made things to where and how they lived and moved. Railroads rewrote not only world geography but also the history of maps and mapping. Today, the needs of train companies and their users continue to shape the maps we consume and consult. Featuring full-color maps primarily from the British Library's distinguished collection—many of them never before published—A History of the Railroad in 100 Maps is the first international history of railroads and railroad infrastructure told through maps. Jeremy Black includes examples from six continents, spanning a variety of uses from railroad planning and operations to guides for passengers, shippers, and tourists. Arranged chronologically, the maps are accompanied by explanatory text that sheds light on the political, military, and urban development histories associated with the spread of railroads. A final chapter considers railroad maps from games, books, and other cultural artifacts. For anyone interested in the history of railroads or maps, A History of the Railroad in 100 Maps will offer new and unexpected insights into their intertwined global history.
A Hitchhiker's Guide to Virtual Reality
by Karen McMenemy Robin Stuart FergusonA Hitchhiker's Guide to Virtual Reality brings together under one cover all the aspects of graphics, video, audio, and haptics that have to work together to make virtual reality a reality. Like any good guide, it reveals the practical things you need to know, from the viewpoint of authors who have been there. This two-part guide covers the science, technology, and mathematics of virtual reality and then details its practical implementation. The first part looks at how the interface between human senses and technology works to create virtual reality, with a focus on vision, the most important sense in virtual reality. The second part of the book is tightly integrated with an accompanying CD, which contains the programs for more than 30 virtual reality projects, ranging in scope from a tool that simulates virtual sculpting to a suite of software for the control of a four-projector immersive virtual environment.
A Hole at the Bottom of the Sea: The Race to Kill the BP Oil Gusher
by Joel AchenbachThe struggle to kill the BP Macondo gusher in the Gulf of Mexico is the Apollo 13 of our time—this is the thrilling story of the nightmare well and the men who conquered it in dangerous waters.Suspensful and illuminating, Joel Achenbach offers a groundbreaking account of the Deepwater Horizon disaster and what came after. The tragic explosion on the huge drilling rig in April 2010 killed eleven men and triggered an environmental disaster. As a gusher of crude surged into the Gulf&’s waters, BP engineers and government scientists—awkwardly teamed in Houston—raced to devise ways to plug the Macondo well. Achenbach, a veteran reporter for The Washington Post and acclaimed science writer for National Geographic, moves beyond the blame game to tell the gripping story of what it was like behind the scenes, moment by moment, in the struggle to kill Macondo. Here are the controversies, the miscalculations, the frustrations, and ultimately the technical triumphs of men and women who worked out of sight and around the clock for months to find a way to plug the well. The government did not have the means to solve the problem; only the private sector had the tools, and it didn&’t have the right ones as the country became haunted by Macondo&’s black plume, which was omnipresent on TV and the internet. Remotely operated vehicles, the spaceships of the deep, had to perform the challenging technical maneuvers on the seafloor. Engineers choreographed this robotic ballet and crammed years of innovation into a single summer. As he describes the drama in Houston, Achenbach probes the government investigation into what went wrong in the deep sea. A confounding mystery and an engineering whodunit, the lessons of this tragedy can be applied broadly to all complex enterprises and should make us look more closely at the highly engineered society that surrounds us.
A Holistic Approach to Lessons Learned: How Organizations Can Benefit from Their Own Knowledge
by Moria LevyThe book presents a holistic approach to organization performance improvements by lessons learned management. Such an approach is required because specific methods, such as debriefing, task management or procedures updates, do not achieve actual improvements. The presented model spans the entire life cycle of lessons learned: Starting from creating new lessons, moving on to knowledge refining and ending with smart integration into the organizational environment so future re-use of knowledge is enabled. The model also addresses other sources of organizational learning including quality processes and employee experience utilization.
A Holistic Approach to Ship Design: Volume 1: Optimisation of Ship Design and Operation for Life Cycle
by Apostolos PapanikolaouThis book introduces a holistic approach to ship design and its optimisation for life-cycle operation. It deals with the scientific background of the adopted approach and the associated synthesis model, which follows modern computer aided engineering (CAE) procedures. It integrates techno-economic databases, calculation and multi-objective optimisation modules and s/w tools with a well-established Computer-Aided Design (CAD) platform, along with a Virtual Vessel Framework (VVF), which will allow virtual testing before the building phase of a new vessel. The resulting graphic user interface (GUI) and information exchange systems enable the exploration of the huge design space to a much larger extent and in less time than is currently possible, thus leading to new insights and promising new design alternatives. The book not only covers the various stages of the design of the main ship system, but also addresses relevant major onboard systems/components in terms of life-cycle performance to offer readers a better understanding of suitable outfitting details, which is a key aspect when it comes the outfitting-intensive products of international shipyards. The book disseminates results of the EU funded Horizon 2020 project HOLISHIP.
A Holistic Approach to Ship Design: Volume 2: Application Case Studies
by Apostolos PapanikolaouThis book deals with modern Computer-Aided Design (CAD) software tools and platforms implemented in ship design, the integration of techno-economic databases, the use of optimisation and simulation software tools, which are integrated in these platforms, and the virtual modelling of ships and their operation by using a Virtual Vessel Framework (VVF). It contains a series of application case studies related to the developed holistic approach to ship design and operation. Nine case studies are described, referring to the design and operation of various ship types, namely RoPax, cruise ship, double-ended ferry, bulk carrier, containership, offshore support vessel, ocean surveillance ship and research vessel and one offshore structure. All case studies are driven by leading representatives of the European Maritime Industry. This book complements A Holistic Approach to Ship Design, volume 1, which covers methods and tools for the life cycle optimisation and assessment of ship design and operation.
A Holistic Solution for Smart Grids based on LINK– Paradigm: Architecture, Energy Systems Integration, Volt/var Chain Process (Power Systems)
by Albana Ilo Daniel-Leon SchultisThis book presents a holistic solution for Smart Grids that includes the electricity: producers, electricity storages, grids, market and customer plants. The authors have derived the architectural paradigm for Smart Grids LINK from the signature of their fractal structure. The presented LINK-based holistic architecture enables the large-scale integration of distributed energy resources by minimising the data to be exchanged, thus considering privacy and cyber security by design. The straightforwardness of LINK-Solution is related to its standardised structures, enabling the coupling of energy and non-energy sectors and Energy Communities. The Volt/var chain control as one of the most challenging operation processes of Smart Grids is covered in detail in this edition. Chapter by chapter, the reader is smoothly introduced to this unique solution, facilitating its practical implementation. This book is a valuable resource for experts, consultants, engineers, scientists, and students in the Smart Grids area and actors of the electricity market and politicians.
A Honeybee Heart Has Five Openings: A Year of Keeping Bees
by Helen JukesA Honeybee Heart Has Five Openings begins as Helen Jukes is entering her thirties and struggling to settle into her new job and home. Then friends gift her a colony of honeybees—a gift that, according to folklore, brings good luck—and Jukes embarks on the rewarding, perilous journey of becoming a beekeeper.Jukes writes about what it means to "keep" wild creatures and to live alongside beings whose laws of life are so different from our own. She delves into the history of beekeeping, exploring the ancient—and sometimes disturbing—relationship between keeper and bee, human and wild thing. And as her colony grows, the very act of beekeeping seems to open new perspectives, making her world come alive again. A beautifully wrought meditation on uncertainty and hope, feelings of restlessness and home, and how we might better know ourselves, A Honeybee Heart Has Five Openings shows us how to be alert to these small creatures flitting among us that are yet so vital a force for the continuation of life.
A Hooded Crow (The Kenneth Aubrey & Patrick Hyde Series)
by Craig ThomasNew York Times–Bestselling Author of The Last Raven: Two British intelligence veterans race to stop lethal weapons from falling into dangerous hands . . . Andrew Babbington has gone over to the enemy, working on industrial espionage for the KGB. But between the impatient Russians who want to get their hands on some advanced tech, and the British intelligence specialists who&’ve trained their sights on the manufacturers who supply them, his efforts could fall apart at any moment—especially after the discovery of a downed plane in the Namibian desert, and the illicit cargo it was carrying. Now, Sir Kenneth Aubrey and Patrick Hyde of MI6 are working off a tip about some shady businessmen with access to terrifying weapons. They&’re willing to sell to the highest bidder—no matter how disreputable. To prevent the deaths of innocent people, the seasoned warriors must spring into action. The geopolitical landscape may be shifting in unpredictable ways, but Aubrey and Hyde know that some things never change—including greed . . . Praise for Craig Thomas&’s thrillers &“Lively, straightforward action.&” —Kirkus Reviews (starred review) &“The last word in espionage thrillers.&” —The Pittsburgh Press
A Human Algorithm: How Artificial Intelligence Is Redefining Who We Are
by Flynn ColemanA groundbreaking narrative on the urgency of ethically designed AI and a guidebook to reimagining life in the era of intelligent technology.The Age of Intelligent Machines is upon us, and we are at a reflection point. The proliferation of fast–moving technologies, including forms of artificial intelligence akin to a new species, will cause us to confront profound questions about ourselves. The era of human intellectual superiority is ending, and we need to plan for this monumental shift.A Human Algorithm: How Artificial Intelligence Is Redefining Who We Are examines the immense impact intelligent technology will have on humanity. These machines, while challenging our personal beliefs and our socioeconomic world order, also have the potential to transform our health and well–being, alleviate poverty and suffering, and reveal the mysteries of intelligence and consciousness. International human rights attorney Flynn Coleman deftly argues that it is critical that we instill values, ethics, and morals into our robots, algorithms, and other forms of AI. Equally important, we need to develop and implement laws, policies, and oversight mechanisms to protect us from tech’s insidious threats.To realize AI’s transcendent potential, Coleman advocates for inviting a diverse group of voices to participate in designing our intelligent machines and using our moral imagination to ensure that human rights, empathy, and equity are core principles of emerging technologies. Ultimately, A Human Algorithm is a clarion call for building a more humane future and moving conscientiously into a new frontier of our own design.“[Coleman] argues that the algorithms of machine learning––if they are instilled with human ethics and values––could bring about a new era of enlightenment.” —San Francisco Chronicle
A Human Error Approach to Aviation Accident Analysis: The Human Factors Analysis and Classification System
by Douglas A. Wiegmann Scott A. ShappellHuman error is implicated in nearly all aviation accidents, yet most investigation and prevention programs are not designed around any theoretical framework of human error. Appropriate for all levels of expertise, the book provides the knowledge and tools required to conduct a human error analysis of accidents, regardless of operational setting (i.e. military, commercial, or general aviation). The book contains a complete description of the Human Factors Analysis and Classification System (HFACS), which incorporates James Reason's model of latent and active failures as a foundation. Widely disseminated among military and civilian organizations, HFACS encompasses all aspects of human error, including the conditions of operators and elements of supervisory and organizational failure. It attracts a very broad readership. Specifically, the book serves as the main textbook for a course in aviation accident investigation taught by one of the authors at the University of Illinois. This book will also be used in courses designed for military safety officers and flight surgeons in the U.S. Navy, Army and the Canadian Defense Force, who currently utilize the HFACS system during aviation accident investigations. Additionally, the book has been incorporated into the popular workshop on accident analysis and prevention provided by the authors at several professional conferences world-wide. The book is also targeted for students attending Embry-Riddle Aeronautical University which has satellite campuses throughout the world and offers a course in human factors accident investigation for many of its majors. In addition, the book will be incorporated into courses offered by Transportation Safety International and the Southern California Safety Institute. Finally, this book serves as an excellent reference guide for many safety professionals and investigators already in the field.
A Hybrid Approach for Power Plant Fault Diagnostics (Studies in Computational Intelligence #743)
by Tamiru Alemu LemmaThis book provides a hybrid approach to fault detection and diagnostics. It presents a detailed analysis related to practical applications of the fault detection and diagnostics framework, and highlights recent findings on power plant nonlinear model identification and fault diagnostics. The effectiveness of the methods presented is tested using data acquired from actual cogeneration and cooling plants (CCPs). The models presented were developed by applying Neuro-Fuzzy (NF) methods. The book offers a valuable resource for researchers and practicing engineers alike.
A Impressão 3D
by Bob BabsonGostaria de comprar uma impressora 3D mas não tem ideia de qual comprar? Gostaria de aprender como começar com as impressoras 3D, com o objetivo de imprimir objetos e designs incríveis? Nesse livro você irá aprender tudo sobre a impressão 3D e como começar. Aprenda: -Como começar -Qual impressora 3D comprar -Características e capacidade das impressoras 3D + MUITO MAIS!
A Journey Around the Different Scales Involved in the Description of Matter and Complex Systems: A Brief Overview with Special Emphasis on Kinetic Theory Approaches (SpringerBriefs in Applied Sciences and Technology)
by Francisco Chinesta Emmanuelle Abisset-ChavanneThis SpringerBrief covers the main scales of description of matter, starting at its finest level, the quantum scale, moving through ab-initio, molecular dynamics, coarse grained approaches, to finish at the scale of kinetic theory models that allows a nice compromise between the rich but expensive microscopic descriptions and the computationally cheap but sometimes too coarse macroscopic descriptions. The book addresses undergraduate and graduate students, as well as beginners in multi-scale modeling of materials.
A Journey Towards Bio-inspired Techniques in Software Engineering (Intelligent Systems Reference Library #185)
by Bhabani Shankar Prasad Mishra Satchidananda Dehuri Jagannath Singh Saurabh BilgaiyanThis book covers a range of basic and advanced topics in software engineering. The field has undergone several phases of change and improvement since its invention, and there is significant ongoing research in software development, addressing aspects such as analysis, design, testing and maintenance. Rather than focusing on a single aspect of software engineering, this book provides a systematic overview of recent techniques, including requirement gathering in the form of story points in agile software, and bio-inspired techniques for estimating the effort, cost, and time required for software development. As such it is a valuable resource for new researchers interested in advances in software engineering — particularly in the area of bio-inspired techniques.
A Journey into Security Certification: From the Cloud to Artificial Intelligence (Synthesis Lectures on Information Security, Privacy, and Trust)
by Ernesto Damiani Claudio Agostino Ardagna Nabil El Ioini Marco AnisettiThis book, authored by some of the pioneers in the security certification domain, provides a foundational knowledge base for designing and deploying effective security certification schemes for cloud-edge distributed systems. It gives readers unique and essential insight into the history of security certification and its evolution from static to dynamic models. The book helps readers to understand the importance of security certification across distributed system evolution from cloud-based to artificial intelligence-machine learning systems. It covers in full the certification of cloud-based composite services, discussing the role of multi-factor certification. It also emphasizes processes for continuously certifying services across system and context changes, as well as the certification of the deployment environment and development process and their impact on the overall cloud service certification. The book considers and challenges existing security certification schemes for cloud services, discussing issues and gaps when applied to modern systems in the cloud-edge continuum and built on artificial intelligence. Readers will become familiar with the challenges in certifying cloud-edge distributed systems and machine learning-based systems. This book also provides actionable insight to readers who manage modern security systems. Security controls have grown in size and complexity, requiring reliable and sustainable certification schemes to support varying quality standards and produce compliant products. It covers the logic behind security standards and the evaluation criteria of main certification standards, further discussing the evolution and corresponding certification of distributed systems towards cloud, cloud-edge, and artificial intelligence. The book teaches readers how to build faster, scalable, and more reliable cloud-edge distributed systems and beyond.
A Journey into the World of Exponential Functions
by Gautam BandyopadhyayThe number e, the function ex, the logarithmic function in (x) and different hyperbolic functions like cosh (x), sinh (x) make frequent appearances in science and engineering textbooks. Students often fail to appreciate the significance of these mathematical symbols. This book clearly illustrates why such abstract mathematical entities are needed to represent some aspects of physical reality. It provides an overview of different types of numbers and functions along with their historical background and applications. It contains four chapters covering number system, exponential function, logarithmic functions and hyperbolic functions along with the concept of complex angle. Print edition not for sale in South Asia (India, Sri Lanka, Nepal, Bangladesh, Pakistan or Bhutan)
A Journey of Embedded and Cyber-Physical Systems: Essays Dedicated to Peter Marwedel on the Occasion of His 70th Birthday
by Jian-Jia ChenThis Open Access book celebrates Professor Peter Marwedel's outstanding achievements in compilers, embedded systems, and cyber-physical systems. The contributions in the book summarize the content of invited lectures given at the workshop “Embedded Systems” held at the Technical University Dortmund in early July 2019 in honor of Professor Marwedel's seventieth birthday.Provides a comprehensive view from leading researchers with respect to the past, present, and future of the design of embedded and cyber-physical systems;Discusses challenges and (potential) solutions from theoreticians and practitioners on modeling, design, analysis, and optimization for embedded and cyber-physical systems;Includes coverage of model verification, communication, software runtime systems, operating systems and real-time computing.
A Just Transition to Decarbonisation: Themes of Loss and Damage, Transport, Nature and Youth (Just Transitions)
by Gerry Nagtzaam Jadranka Petrovic Diane Kraal Katie O’Bryan Susie Siew HoThis book provides researchers and policy-makers with legal avenues to enable a just transition to decarbonisation. The focus is on the United Nations themes of loss and damage, transport, nature and youth - across Australia and other economies - to significantly reduce CO2 emissions by 2030 and beyond. The four themes scaffold discussions about a just transition beyond the UN Climate Change Conference COP28 in Dubai with the specific issues addressed in this book serving as a starting point for future discussions.