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Validating Pharmaceutical Systems: Good Computer Practice in Life Science Manufacturing
by John AndrewsAll too often, the words "computer validation" strike terror into the hearts of those new to the process and may even cause those familiar with it to tremble. Validating Pharmaceutical Systems: Good Computer Practice in Life Science Manufacturing delineates GCP, GLP, and GMP regulatory requirements and provides guidance from seasoned practitioners
Validation Compliance Annual: 1995
by International Validation Forum"Offers an overview of validation and the current regulatory climate and provides a compendium of the regulations, guidance documents, issues, compliance tools, terminology, and literature involved in computer systems validation. Thoroughly examines regulations issued by the U.S. Food and Drug Administration, the U.S. Environmental Protection Agency, and the European Union. Furnishes case studies of real-world situations."
Validation Standard Operating Procedures: A Step by Step Guide for Achieving Compliance in the Pharmaceutical, Medical Device, and Biotech Industries
by Syed Imtiaz HaiderSpanning every critical element of validation for any pharmaceutical, diagnostic, medical device or equipment, and biotech product, this Second Edition guides readers through each step in the correct execution of validating processes required for non-aseptic and aseptic pharmaceutical production. With 14 exclusive environmental performance evaluati
Validation and Qualification in Analytical Laboratories
by Ludwig HuberThis Second Edition discusses ways to improve pharmaceutical product quality while achieving compliance with global regulatory standards. With comprehensive step-by-step instructions, practical recommendations, standard operating procedures (SOPs), checklists, templates, and graphics for easy incorporation in a laboratory. This title
Validation and Reconstruction of Remote Sensing Land Surface Temperature Products
by Wei Zhou Lei Fan Wenping Yu Yuechen Li Xujun Han Mingguo Ma Weiyu ShiThis book focuses on validation and reconstruction work on the land surface temperature (LST) products retrieved by thermal infrared remote sensing. The LST is a key parameter in the energy-water balance process and has been widely used in research on the global climate change, water cycle, vegetation growing, and drought detection. Remote sensing retrieving LST is the most important source for regional and even global application. However, there are several factors that limited their widespread use: (1) the thermal infrared remote sensing is easily influenced by clouds; therefore, there are lots of pixel with invalid LST; (2) LST products have not been sufficiently validated in global scale. This book arms to overcome above defects and guide the readers to estimate the LST of cloudy pixel and implement the general validation on the remote sensing LST. Furthermore, it helps to understand the scale mismatch between different observation and land surface heterogeneity. The book covers ground-based observation, validation and reconstruction theories, scale mismatch analysis, heterogeneity and representativeness evaluation for observations, and application cases. It is an essential reference to the quantitative retrieval of thermal infrared remote sensing technologies.
Validation for Medical Device and Diagnostic Manufacturers
by Carol V. Desain Charmaine V. SuttonImplementation of FDA's Design Control requirements (21 CFR 820.30) changed an entire industry. Quality System Requirements defined the approach to medical device validation. Product design, manufacturing process, and test method validation studies must be performed before or as a product is transferred to commercial production. Validation studies
Validation of Bioanalytical Methods (essentials)
by Patric U. Vogelthis book, the validation of bioanalytical methods is described. In the quality control of biological medicinal products, bioanalytical methods are frequently used to check important properties such as the content or possible impurities. The methods used must provide trustworthy results so that no false conclusions are drawn when evaluating the results. The trustworthiness is ensured by validation. The validation of bioanalytical methods is illustrated by means of some examples.
Validation of Computerized Analytical Systems
by Ludwig HuberValidation of Computerized Analytical and Networked Systems provides the definitive rationales, logic, and methodology for validation of computerized analytical systems. Whether you are involved with formulation or analytical development laboratories, chemical or microbiological quality control laboratories, LIMS installations, or any aspect of robotic in a healthcare laboratory, this book furnishes complete validation details.International and FDA regulations and requirements are discussed and juxtaposed with numerous practical examples that show you how to cost-effectively and efficiently accomplish validation acceptable to FDA GCP/GLP/GMP, NAMAS, and EN45001 standards. The templates included provide documentation examples and the many checklists found throughout the book assure that all aspects of covered in a logical sequence. The chapters describe and explain such topics as the Product Life Cycle revalidation, change control, documentation requirements, qualifications, testing, data validation and traceability, inspection, SOPs, and many other that help streamline the validation process.
Validierung (essentials)
by Patric U. VogelIn diesem Buch wird die Validierung analytischer Methoden beschrieben. Bei der Qualitätskontrolle von biologischen Arzneimitteln kommen häufig biologisch-analytische Methoden zum Einsatz, um wichtige Eigenschaften wie den Gehalt oder mögliche Verunreinigungen zu überprüfen. Die eingesetzten Methoden müssen vertrauenswürdige Ergebnisse liefern, damit bei der Bewertung der Ergebnisse keine falschen Schlüsse gezogen werden. Die Vertrauenswürdigkeit wird durch eine Validierung sichergestellt. Die Validierung von analytischen Methoden wird anhand einiger Beispiele dargestellt. Die geänderten Vorgaben ab Juni 2024 sind berücksichtigt.
Validierung bioanalytischer Methoden (essentials)
by Patric U. VogelIn diesem Buch wird die Validierung bioanalytischer Methoden beschrieben. Bei der Qualitätskontrolle von biologischen Arzneimitteln kommen häufig bioanalytische Methoden zum Einsatz, um wichtige Eigenschaften wie den Gehalt oder mögliche Verunreinigungen zu überprüfen. Die eingesetzten Methoden müssen vertrauenswürdige Ergebnisse liefern, damit bei der Bewertung der Ergebnisse keine falschen Schlüsse gezogen werden. Die Vertrauenswürdigkeit wird durch eine Validierung sichergestellt. Die Validierung von bioanalytischen Methoden wird anhand einiger Beispiele dargestellt.
Validierung in der Analytik (Die Praxis der instrumentellen Analytik)
by Stavros KromidasDie Validierung von Methoden und Geräten ist eine elementare Aufgabe in jedem analytischen Labor. Erstmals liegt mit diesem Band der Reihe eine praktische Einführung für den Anwender vor. In didaktisch bewährter Form werden die einzelnen Validierungsparameter ausführlich erklärt, kommentiert und ihre Verknüpfung erläutert. Der Leser wird sukzessiv durch die Validierungsschritte geführt, von der Fragestellung bis zur Bewertung der Ergebnisse und Plausibilitätsbetrachtung. Er erhält konkrete Hilfestellung in Form von Fallbeispielen, Checklisten und Diagrammen sowie durch Antworten auf typische Fragen und Hinweise zur Vermeidung typischer Fehler. Ergänzend dazu enthält das Buch ein Glossar und einen Anhang mit nützlichen weiterführenden Informationen. Es ist der Begleiter für alle Anwender, die validieren müssen. Aus Rezensionen bereits erschienener Bände: 'Das sehr empfehlenswerte Werk ist didaktisch geschickt formuliert und illustriert [...]. Es setzt die bewährte Reihe zur Praxis der instrumentellen Analytik fort und sollte in keiner einschlägigen Fachbibliothek fehlen.' (Die Pharmazeutische Industrie) 'Besonders lehrreich für den Anfänger ist die Vielzahl von praktischen Beispielen' (Die Nahrung)
Validity Assessment in Clinical Neuropsychological Practice: Evaluating and Managing Noncredible Performance (Evidence-Based Practice in Neuropsychology)
by Ryan W. Schroeder and Phillip K. MartinPractical and comprehensive, this is the first book to focus on noncredible performance in clinical contexts. Experts in the field discuss the varied causes of invalidity, describe how to efficiently incorporate validity tests into clinical evaluations, and provide direction on how to proceed when noncredible responding is detected. Thoughtful, ethical guidance is given for offering patient feedback and writing effective reports. Population-specific chapters cover validity assessment with military personnel; children; and individuals with dementia, psychiatric disorders, mild traumatic brain injury, academic disability, and other concerns. The concluding chapter describes how to appropriately engage in legal proceedings if a clinical case becomes forensic. Case examples and sample reports enhance the book's utility.
Valley of Forgetting: Alzheimer's Families and the Search for a Cure
by Jennie Erin SmithThe riveting account of a community from the remote mountains of Colombia whose rare and fatal genetic mutation is unlocking the secrets of Alzheimer&’s disease&“Powerful. . . . a poignant depiction of a community in crisis.&” —Publishers WeeklyIn the 1980s, a neurologist named Francisco Lopera traveled on horseback into the mountains seeking families with symptoms of dementia. For centuries, residents of certain villages near Medellín had suffered memory loss as they reached middle age, going on to die in their fifties. Lopera discovered that a unique genetic mutation was causing their rare hereditary form of early onset Alzheimer&’s disease. Over the next forty years of working with the &“paisa mutation&” kindred, he went on to build a world-class research program in a region beset by violence and poverty.In Valley of Forgetting, Jennie Erin Smith brings readers into the clinic, the laboratories, and the Medellín trial center where Lopera&’s patients receive an experimental drug to see if Alzheimer&’s can be averted. She chronicles the lives of people who care for sick parents, spouses, and siblings, all while struggling to keep their own dreams afloat. These Colombian families have donated hundreds of their loved ones&’ brains to science and subjected themselves to invasive testing to help uncover how Alzheimer&’s develops and whether it can be stopped. Findings from this unprecedented effort could hold the key to understanding and treating the disease, though it is unclear what, if anything, the families will receive in return.Smith&’s immersive storytelling brings this complex drama to life, inviting readers on a scientific journey that is as deeply moving as it is engrossing.
Valorisation of Agro-industrial Residues – Volume I: Biological Approaches (Applied Environmental Science and Engineering for a Sustainable Future)
by Zainul Akmar Zakaria Ramaraj Boopathy Julian Rafael DibAgriculture and industry are the two most important economic sectors for various countries around the globe, providing millions of jobs as well as being the main source of income for these countries. Nevertheless, with the increasing demand for agricultural and industrial produce, huge amounts of waste are also being produced. Without proper management, this waste (both liquid and solid) poses a serious threat to overall environmental quality, mainly due to its toxicity and slow degradation processes. Current approaches are effective but would normally require huge capital investments, are labour intensive and generate potential hazardous by-products. As such, there is a need for alternative approaches that are cheaper, easier-to-handle and have a minimum potential impact on environmental quality. This book presents up-to-date approaches using biological techniques to manage the abundance of waste generated from agricultural and industrial activities. It discusses techniques such as bioconversion, biodegradation, biotransformation, and biomonitoring as well as the utilization of these wastes. A number of chapters also include individual case studies to enhance readers’ understanding of the topics. This comprehensive book is a useful resource for anyone involved in agricultural and industrial waste management, green chemistry or biotechnology. It is also recommended as a reference work for graduate students and all agriculture and biotechnology libraries.
Valorisation of Agro-industrial Residues – Volume II: Non-Biological Approaches (Applied Environmental Science and Engineering for a Sustainable Future)
by Zainul Akmar Zakaria Cristobal N Aguilar Ratna Dewi Kusumaningtyas Parameswaran BinodThe world’s population is expected to reach the eight billion mark very soon. As a result, there is a need for increased industrial and agricultural production to ensure human wellbeing. This in turn generates huge amounts of waste. Current waste treatment solutions are effective, but usually require huge capital investment, are labour intensive and potentially lead to hazardous by-products. This book presents the latest non-biological approaches to address issues related to the abundance of waste, offering insights into best practices in various regions around the globe. It highlights techniques such as chemical extraction, pyrolysis and ultrasonics, and a number of chapters include individual case studies to further enhance readers’ understanding. This comprehensive reference resource is intended for graduate students, researchers and scientists, and is also a valuable addition to all agriculture and biotechnology libraries.
Valorisation of Waste and Secondary Materials for Roads: State-of-the-Art Report of the RILEM TC 279-WMR (RILEM State-of-the-Art Reports #38)
by Di Wang Augusto Cannone Falchetto Lily Poulikakos Emiliano PasquiniThis book presents the work of the RILEM TC 279-WMR, whose purpose was to facilitate the use of waste, marginal and secondary materials for roads by investigating the performance of road materials containing waste through round robin tests and the development of standard procedures for their selection, preparation, and use. The structure of this book includes an introduction, five technical chapters, and a conclusion. The topics addressed are: the use of asphalt binder additives such as plastic and rubber; the combined use of aggregate and filler substitute in paving mixtures (construction demolition waste, rubber, and steel slags); the environmental assessment and the potential sources of pollutants originated from the use of this recycled materials.
Valorization of Agro-Industrial Byproducts: Sustainable Approaches for Industrial Transformation
by Anil Kumar Anal and Parmjit S. PanesarThis book covers sustainable approaches for industrial transformation pertaining to valorization of agro-industrial byproducts. Divided into four sections, it starts with information about the agro/food industry and its byproducts, including their characterization, followed by different green technologies (principle, process strategies and extraction of bioactive compounds) applied for the management of agro industry byproducts. It further explains biotechnological interventions involved in the value addition of these byproducts. Various regulatory and environmental concerns related to by-product management along with biorefinery concept and future strategies are provided as well. Features: Provides extensive coverage of agro-industrial by products and their environmental impact. Details production of value-added products from agro-industrial waste. Describes environmental legislations and future strategies. Presents multidisciplinary approaches from fundamental to applied and addresses the biorefinery and circular economy. Includes innovative approaches and future strategies for management of agro-industrial waste. This book is aimed at researchers, graduate students and professionals in food science/food engineering, bioprocessing/biofuels/bioproducts/biochemicals and agriculture, bioeconomy, food waste processing, post-harvest processing, and waste management.
Valorization of Biomass Wastes for Environmental Sustainability: Green Practices for the Rural Circular Economy
by Mukesh Kumar Arun Lal Srivastav Abhishek Kumar BhardwajThis volume discusses the reduction, recycling, and reuse of industrial and agricultural biomass wastes to develop value-added products using environmentally sustainable practices and technologies. Through these waste valorization approaches, biomass waste materials can be converted into useful bio-chemical products, sustainable construction materials, polymers, bio-energy, and bio-fuel as sustainable alternatives to products and materials with negative environmental and health consequences. The chapters highlight the development and implementation of eco-friendly solutions to biomass waste production with the aim of reducing natural resource deterioration, bolstering rural and small-scale business systems in communities impacted by pollution and climate change, and providing power from residual biomass to broadly reduce environmental impacts through improved waste management practices. The book is intended to be a useful resource for researchers, policymakers, NGOs, government agencies, and local community authorities working in waste management and environmental sustainability.
Valorization of Biomass to Value-Added Commodities: Current Trends, Challenges, and Future Prospects (Green Energy and Technology)
by Michael O. Daramola Augustine O. AyeniThis book presents the most up-to-date technologies for the transformation of biomass into valuable fuels, chemicals, materials, and products. It provides comprehensive coverage of the characterization and fractionation of various types of biomass and details the many challenges that are currently encountered during this process. Divided into two sections, this book discusses timely topics such as the characterization of biomass feedstock, pretreatment and fractionation of biomass, and describes the process for conversion of biomass to value-added commodities. The authors bring biomass transformational strategies that are yet to be explored to the forefront, making this innovative book useful for graduate students and researchers in academia, government, and industry.
Valorization of Citrus Food Waste
by Ali Imran Anamika Chauhan Fakhar Islam Jagbir Singh AswalThe establishment of fruit juice companies in the 20th century marked the beginning of the widespread use of citrus fruits. Around 18% of the total citrus fruit production in the world is used industrially, primarily for the manufacture of juice. Citrus fruit consumption and interest are growing, and trash generation is also increasing, adding to the environmental load. Because of their unwanted and unsanitary character, discarding fruit segments without due care is hazardous to the environment. Producing citrus juice results in the creation of waste, which accounts for over 50% of the mass of fresh fruit. Peels, seeds pomace, and wastewater are all included in this waste. Fruitpeels, seeds, and pulp from ruined fruit are covered with citrus wastewater. About 10 million MT of trash are produced annually by the processing of citrus fruit worldwide, which poses a severe ecological problem. Citrus by-products are troublesome wastes because of their abundance and perishablenature. Citrus peels that are around 80%water decay fast, attracting bugs, bacteria and mold. Citrus peel utilization is therefore essential for waste management and not only a means of boosting revenue. Citrus trash must be disposed of properly since improper disposal pollutes the land and water, further harming the aquatic habitat. An efficient strategy for sustainable waste management is to use citrus wastes to create useful bioproducts. Numerous methods have been developed to boost the pectin recovery from citrus trash due to the continuously growing demand. Valorization of Citrus Food Waste presents the high-value compound in the citrus wastes and their extraction methods for obtaining the value-added products as well as their corresponding applications and will be useful to food scientists and industry members exploring the use of valorization process for waste fruits as new components and sources in nutraceuticals. Thisbook is a full of source for the valorization of citrus waste, the use of bioactive components and waste management.
Valorization of Food Processing By-Products (Fermented Foods and Beverages Series)
by M. ChandrasekaranBiotechnology has immense potential for resolving environmental problems and augmenting food production. Particularly, it offers solutions for converting solid wastes into value-added items. In food processing industries that generate voluminous by-products and wastes, valorization can help offset growing environmental problems and facilitate the s
Valorization of Wine Making By-Products
by Matteo BordigaAn overview of wine making by-products and their conventional and non-conventional uses, Valorization of Wine Making By-Products gives you a deeper understanding of recovery processes that are a part of the new philosophy of sustainable agriculture. In line with the worldwide movement toward sustainable development, this book examines how to conver
Valuation and Sustainability: A Guide to Include Environmental, Social, and Governance Data in Business Valuation (Sustainable Finance)
by Dejan GlavasDo you want to know how to integrate environmental, social, and governance (ESG) data into business valuation? This book will help you do so step-by-step. The book primarily aims at reaching two types of audiences: practitioners and students in finance (graduate and undergraduate level). Practitioners in finance will find interest in the book, as it will give them access to academic knowledge in a format that suits them. Academic research has made substantial advances in the field of business valuation and ESG. The book intends to transform this knowledge into practical and rigorous methodologies for taking ESG into account when valuing a company. Graduate and undergraduate courses have recently developed in business schools, universities, and engineering schools. These courses usually directly refer to academic articles or valuation companies' website documentation, but not to academic books. Therefore, the book will allow students to have access to centralized and organized information about business valuation and ESG. Readers without prior knowledge of business valuation will be guided through the ESG integration process. They will first be introduced to the concept of value and the reasons for incorporating ESG into the value. They will then learn simple financial methods to value firms and see step-by-step use cases. For instance, the reader will learn how to value a firm in the renewable energy sector using cash flow and multiple valuation methods. After building knowledge of standard business valuation, readers will better understand ESG data and ratings. The reader will then learn how to integrate ESG into business valuation using cash flow and multiples approaches. Again, the reader will be able to replicate these methods as the book will provide practical cases for integrating ESG data in business valuation. Finally, for the readers that intend to go a bit further, they will learn about the academic research advances in ESG and business valuation.
Valuation of Ecological Resources: Integration of Ecology and Socioeconomics in Environmental Decision Making
by Lawrence A. Kapustka Wayne R. Munns Jr. Randall J. Bruins Ralph G. Stahl Jr.Choosing the optimal management option requires environmental risk managers and decision makers to evaluate diverse, and not always congruent, needs and interests of multiple stakeholders. Understanding the trade-offs of different options as well as their legal, economic, scientific, and technological implications is critical to performing accurate
Valuation of Network Effects in Software Markets: A Complex Networks Approach
by Andreas KemperThe customer base is an important value driver of software companies and a reliable prediction of its development is fundamental for investment decisions. A particularity in software markets is that an individual's purchasing decision is often influenced by other users' choices. Although such customer network effects are evident, their quantitative assessment remain elusive with conventional approaches. This book contributes to closing this gap by developing methods for measuring network effects and their implications for valuation in software markets. Based on the theory of complex networks the book reveals that such diffusion processes highly depend on structural properties of customer networks. Moreover, it depicts that such insights are contributions to improve the quality of valuations in software markets. But the implications of this research also comprise social and political aspects as they can be applied in order to prevent corporate failures in all network effect markets.