Case study details the right way and the wrong way to successfully develop and market a new drug Beginning 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 Processes FDA 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.
This new edition of the classic quantity surveying textbook retains its basic structure but has been thoroughly updated to reflect recent changes in the industry, especially in procurement. Although over the last 20 years a number of new procurement methods have evolved and become adopted, the recession has seen many clients revert to established traditional methods of procurement so the fundamentals of cost planning still apply – and should not be ignored. The first edition of this leading textbook was published in 1964 and it continues to provide a comprehensive introduction to the practice and procedures of cost planning in the procurement of buildings. This 9th edition has been thoroughly updated to reflect changes that have occurred in the UK construction industry in the past six years. Whilst retaining its core structure of the three-phase cost planning process originally developed by Ferry and Brandon, the text provides a thorough grounding in contemporary issues including procurement innovation, whole life cycle costing and modelling techniques. Designed to support the core cost planning studies covered by students reading for degrees in quantity surveying and construction management, it provides a platform for understanding the fundamental importance of effective cost planning practice. The principals of elemental cost planning are covered from both pre- and post- contract perspectives; the role of effective briefing and client/stakeholder engagement as best practice is also reinforced in this text. This new edition: Addresses The Soft Landings Framework (a new govt. initiative, especially for schools) to make buildings perform radically better and much more sustainably. Puts focus on actual performance in use at brief stage, during design and construction, and especially before and after handover. Covers recent changes in procurement, especially under the NEC and PFI Provides more on PPP and long-term maintenance issues Offers an improved companion website with tutorial worksheets for lecturers and Interactive spreadsheets for students, e.g. development appraisal models; lifecycle costing models
The complexity of public-private partnership project procurement requires an effective process for pricing, managing and appropriate allocation of risks. The level at which risk is priced and the magnitude of risks transferred to the private sector will have a significant impact on the cost of the PPP deals as well as on the value for money analysis and on the section of the optimum investment options. The construction industry tends to concentrate on the effectiveness of risk management strategies and to some extent ignores the price of risk and its impact on whole life cost of building assets. There is a pressing need for a universal framework for the determination of fair value of risks throughout the PPP procurement processes. Risk Pricing Strategies for Public-Private Partnership Projects addresses the issues of risk pricing and demonstrates the use of a coherent strategy to arrive at a fair risk price. The focus of the book is on providing risk pricing strategies to maximise return on risk retention and allocation in the procurement of PPP projects. With its up-to-date coverage of the latest developments in risk pricing and comprehensive treatment of the methodologies involved in designing and building risk pricing strategies, the book offers a simple model for pricing risks. The book follows a thematic structure: PPP processes map; Risk, uncertainty and bias; Risk pricing management strategies; Risk pricing measurement and modelling; Risk pricing at each of the project life cycle stages – and deals with all the important risk pricing issues, using relevant real-world situations through case study examples. It explains how the theory and strategies of risk pricing can be successfully applied to real PPP projects and reflects the broad understanding required by today’s project risk analysts, in their new and important role in PPP contract management.
A modern and unique perspective on solar and geothermal technologies for heating and cooling buildings This book will have a broad appeal reaching practising engineers in the industry as well as students. With introductory sections for each technology described, material includes chapters on: geothermal energy use for the heating and cooling of buildings; a chapter on electrically driven heat pumps/chillers; material on night radiative cooling, photovoltaic thermal collectors, temperature modelling and thin film photovoltaic modelling. Includes general introductory sections for each technology with market potential and applications Covers an increasingly important component of energy courses Considers a broad range of alternative renewable energy supplies relevant to the building sector, such as geothermal energy with heat pump With a special focus on solar cooling, provides detailed physical models of all technologies and example calculations Unique in covering the fundamentals of meteorological modelling
Soft drinks and fruit juices are produced in almost every country in the world and their availability is remarkable. From the largest cities to some of the remotest villages, soft drinks are available in a variety of flavours and packaging. Over the last decade, soft drinks and fruit juices have been the subject of criticism by the health community and there is considerable pressure on beverage manufacturers to reduce, or even remove, the sugar content of these products. Chemistry and Technology of Soft Drinks and Fruit Juices, Third Edition provides an overview of the chemistry and technology of soft drinks and fruit juices, covering ingredients, processing, microbiology, traceability and packaging as well as global market trends. This fully revised edition now includes chapters on topics that have become prominent in the industry since publication of the previous edition namely: water use and treatment, and microbiology technologies. The book is directed at graduates in food science, chemistry or microbiology entering production, quality control, new product development or marketing in the beverage industry or in companies supplying ingredients or packaging materials to the beverage industry.
Superconducting technology is potentially important as one of the future smart grid technologies. It is a combination of superconductor materials, electrical engineering, cryogenic insulation, cryogenics and cryostats. There has been no specific book fully describing this branch of science and technology in electrical engineering. However, this book includes these areas, and is essential for those majoring in applied superconductivity in electrical engineering. Recently, superconducting technology has made great progress. Many universities and companies are involved in applied superconductivity with the support of government. Over the next five years, departments of electrical engineering in universities and companies will become more involved in this area. This book: • will enable people to directly carry out research on applied superconductivity in electrical engineering • is more comprehensive and practical when compared to other advances • presents a clear introduction to the application of superconductor in electrical engineering and related fundamental technologies • arms readers with the technological aspects of superconductivity required to produce a machine • covers power supplying technologies in superconducting electric apparatus • is well organized and adaptable for students, lecturers, researchers and engineers • lecture slides suitable for lecturers available on the Wiley Companion Website Fundamental Elements of Applied Superconductivity in Electrical Engineering is ideal for academic researchers, graduates and undergraduate students in electrical engineering. It is also an excellent reference work for superconducting device researchers and engineers.
CONCISE, IN-DEPTH COVERAGE OF THE COMPLEX ISSUES OF EASEMENTS AND THEIR REVERSION The definition, use, defense, and retirement of easements are areas of active work for land surveyors, lawyers, and the holders and buyers of easements, such as utility companies and highway departments. Easements Relating to Land Surveying and Title Examination is the most up-to-date reference that succinctly and incisively covers easements and reversions, written for land surveyors and title examiners. This comprehensive guide covers the various forms of easements, their creation, reversion, and termination. Its numerous case studies offer examples of situations in which easements resulted in litigation and reveal how these cases were decided by the courts. The book also includes coverage of undescribed easements and guidance on how to properly write new easement descriptions. This useful, practical handbook: Defines easements and easement terminology Covers both right-of-way and right-of-way line easements Explains the creation of easements by express grant, reservation or exception, agreement or covenant, implication, estoppel, custom, and more Explores all types of easement termination, including expiration, release, merger of title, abandonment, prescription or adverse possession, and many others Provides thorough descriptions of problem easements, from undescribed and blanket easements to hidden and rolling easements Offers extensive coverage of reversion of easements, including highway-related reversions and rules for locating and defining reversions Presents detailed information for land surveyors and title examiners on how to handle these easement issues
Presenting the policy drivers, benefits and challenges for grid integration of electric vehicles (EVs) in the open electricity market environment, this book provides a comprehensive overview of existing electricity markets and demonstrates how EVs are integrated into these different markets and power systems. Unlike other texts, this book analyses EV integration in parallel with electricity market design, showing the interaction between EVs and differing electricity markets. Future regulating power market and distribution system operator (DSO) market design is covered, with up-to-date case studies and examples to help readers carry out similar projects across the world. With in-depth analysis, this book describes: the impact of EV charging and discharging on transmission and distribution networks market-driven EV congestion management techniques, for example the day-ahead tariff based congestion management scenario within electric distribution networks optimal EV charging management with the fleet operator concept and smart charging management EV battery technology, modelling and tests the use of EVs for balancing power fluctuations from renewable energy sources, looking at power system operation support, including frequency reserve, power regulation and voltage support An accessible technical book for power engineers and grid/distributed systems operators, this also serves as a reference text for researchers in the area of EVs and power systems. It provides distribution companies with the knowledge they need when facing the challenges introduced by large scale EV deployment, and demonstrates how transmission system operators (TSOs) can develop the existing system service market in order to fully utilize the potential of EV flexibility. With thorough coverage of the technologies for EV integration, this volume is informative for research professors and graduate students in power systems; it will also appeal to EV manufacturers, regulators, EV market professionals, energy providers and traders, mobility providers, EV charging station companies, and policy makers.
Clear presentation of a new control process applied to induction machine (IM), surface mounted permanent magnet synchronous motor (SMPM-SM) and interior permanent magnet synchronous motor (IPM-SM) Direct Eigen Control for Induction Machines and Synchronous Motors provides a clear and consise explanation of a new method in alternating current (AC) motor control. Unlike similar books on the market, it does not present various control algorithms for each type of AC motor but explains one method designed to control all AC motor types: Induction Machine (IM), Surface Mounted Permanent Magnet Synchronous Motor (SMPM-SM) (i.e. Brushless) and Interior Permanent Magnet Synchronous Motor (IPM-SM). This totally new control method can be used not only for AC motor control but also to control input filter current and voltage of an inverter feeding an AC motor. Accessible and clear, describes a new fast type of motor control applied to induction machine (IM), surface mounted permanent magnet synchronous motor (SM-PMSM) and interior permanent magnet synchronous motor (I-PMSM) with various examples Summarizes a method that supersedes the two known direct control solutions – Direct Self Control and Direct Torque Control – to be used for AC motor control and to control input filter current and voltage of an inverter feeding an AC motor Presents comprehensive simulations that are easy for the reader to reproduce on a computer. A control program is hosted on a companion website This book is straight-forward with clear mathematical description. It presents simulations in a way that is easy to understand and to reproduce on a computer, whilst omitting details of practical hardware implementation of control, in order for the main theory to take focus. The book remains concise by leaving out description of sensorless controls for all motor types. The sections on “Control Process”, “Real Time Implementation” and “Kalman Filter Observer and Prediction” in the introductory chapters explain how to practically implement, in real time, the discretized control with all three types of AC motors. In order, this book describes induction machine, SMPM-SM, IPM-SM, and, application to LC filter limitations. The appendixes present: PWM vector calculations; transfer matrix calculation; transfer matrix inversion; Eigen state space vector calculation; and, transition and command matrix calculation. Essential reading for Researchers in the field of drive control; graduate and post-graduate students studying electric machines; electric engineers in the field of railways, electric cars, plane surface control, military applications. The approach is also valuable for Engineers in the field of machine tools, robots and rolling mills.
Der Bereich Kostenrechnung ist entscheidend fur den wirtschaftlichen Erfolg eines Bauunternehmens. Dementsprechend wichtig ist die genaue und umfassende Kenntnis ihrer Prinzipien und Grundsatze sowie deren Anwendung in allen Projektphasen. Dieses Buch behandelt sowohl die Bauauftragsrechnung, die Betriebsabrechnung als auch das Controlling auf der Ebene des Einzelprojekts wie auch fur das Gesamtunternehmen. Damit ist es das ideale Nachschlagewerk fur die Praxis, insbesondere fur kleine und mittlere Bauunternehmen sowie das Baugewerbe. Wie stelle ich einen Nachtrag auf? Wie mache ich eine korrekte Leistungsmeldung? Wie kontrolliere ich den Stundenverbrauch? Wie ermittele ich das momentane Ergebnis und rechne dieses auf den Abschluss der Bauma?nahme hoch? – Auf diese und viele weitere im Tagesgeschaft auftretende Fragen gibt das Buch praxisnahe Antworten. Dabei wird detailliert auf die kurzlich erschienene KLR-Bau 2016 eingegangen. In dieser wird neben der Kostenstellenrechnung auch die in der stationaren Industrie gebrauchliche Kostentragerrechnung behandelt. Das vorliegenden Buch zeigt anhand von Vergleichsrechnungen die Unterschiede beider Verfahren auf und hinterfragt die Eignung der Kostentragerrechnung fur die Bauwirtschaft. Das Buch ist ebenfalls hervorragend als Lehrbuch im Fach «Baubetrieb» geeignet und stellt somit die Verbindung zwischen Lehre und Praxis her.