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Environmental Quality By Design
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Book Synopsis Green Chemistry and Quality by Design in Process Analytical Technologies and Drug Design by : Suryakanta Swain
Download or read book Green Chemistry and Quality by Design in Process Analytical Technologies and Drug Design written by Suryakanta Swain and published by Cambridge Scholars Publishing. This book was released on 2024-04-10 with total page 162 pages. Available in PDF, EPUB and Kindle. Book excerpt: Quality by design (QbD) is becoming an integral element of the modern pharmaceutical and chemical development approach. In this book, the future ramifications of emergent modern applications of QbD and green analytical chemistry in drug design, process analytical technologies, and bioanalytical process development instruments are discussed. It will reveal and improve the QbD principles used in bioanalysis, process development, downstream processing, and the combination of QbD and green analytical chemistry employing eco-friendly and green solvents for product development. In addition, it will provide complete information regarding applying the QbD concept and ideology to quality control and process development. The book will be beneficial to PhD research scholars, researchers, and postgraduate and undergraduate students of pharmacy and chemical sciences for understanding the concept of quality by design and green chemistry for drug design, as it illustrates the necessary inputs that are related to product quality and, ultimately, process sustainability.
Book Synopsis Quality by Design for Electronics by : W. Fleischammer
Download or read book Quality by Design for Electronics written by W. Fleischammer and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 329 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book concentrates on the quality of electronic products. Electronics in general, including semiconductor technology and software, has become the key technology for wide areas of industrial production. In nearly all expanding branches of industry electronics, especially digital electronics, is involved. And the spread of electronic technology has not yet come to an end. This rapid development, coupled with growing competition and the shorter innovation cycle, have caused economic problems which tend to have adverse effects on quality. Therefore, good quality at low cost is a very attractive goal in industry today. The demand for better quality continues along with a demand for more studies in quality assurance. At the same time, many companies are experiencing a drop in profits just when better quality of their products is essential in order to survive against the competition. There have been many proposals in the past to improve quality without increase in cost, or to reduce cost for quality assurance without loss of quality. This book tries to summarize the practical content of many of these proposals and to give some advice, above all to the designer and manufacturer of electronic devices. It mainly addresses practically minded engineers and managers. It is probably of less interest to pure scientists. The book covers all aspects of quality assurance of components used in electronic devices. Integrated circuits (lCs) are considered to be the most important components because the degree of integration is still rising.
Book Synopsis Pharmaceutical Quality by Design by : Sarwar Beg
Download or read book Pharmaceutical Quality by Design written by Sarwar Beg and published by Academic Press. This book was released on 2019-03-27 with total page 450 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceutical Quality by Design: Principles and Applications discusses the Quality by Design (QbD) concept implemented by regulatory agencies to ensure the development of a consistent and high-quality pharmaceutical product that safely provides the maximum therapeutic benefit to patients. The book walks readers through the QbD framework by covering the fundamental principles of QbD, the current regulatory requirements, and the applications of QbD at various stages of pharmaceutical product development, including drug substance and excipient development, analytical development, formulation development, dissolution testing, manufacturing, stability studies, bioequivalence testing, risk and assessment, and clinical trials. Contributions from global leaders in QbD provide specific insight in its application in a diversity of pharmaceutical products, including nanopharmaceuticals, biopharmaceuticals, and vaccines. The inclusion of illustrations, practical examples, and case studies makes this book a useful reference guide to pharmaceutical scientists and researchers who are engaged in the formulation of various delivery systems and the analysis of pharmaceutical product development and drug manufacturing process. - Discusses vital QbD precepts and fundamental aspects of QbD implementation in the pharma, biopharma and biotechnology industries - Provides helpful illustrations, practical examples and research case studies to explain QbD concepts to readers - Includes contributions from global leaders and experts from academia, industry and regulatory agencies
Book Synopsis Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture by : Gintaras V. Reklaitis
Download or read book Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture written by Gintaras V. Reklaitis and published by John Wiley & Sons. This book was released on 2017-10-09 with total page 418 pages. Available in PDF, EPUB and Kindle. Book excerpt: Covers a widespread view of Quality by Design (QbD) encompassing the many stages involved in the development of a new drug product. The book provides a broad view of Quality by Design (QbD) and shows how QbD concepts and analysis facilitate the development and manufacture of high quality products. QbD is seen as a framework for building process understanding, for implementing robust and effective manufacturing processes and provides the underpinnings for a science-based regulation of the pharmaceutical industry. Edited by the three renowned researchers in the field, Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture guides pharmaceutical engineers and scientists involved in product and process development, as well as teachers, on how to utilize QbD practices and applications effectively while complying with government regulations. The material is divided into three main sections: the first six chapters address the role of key technologies, including process modeling, process analytical technology, automated process control and statistical methodology in supporting QbD and establishing the associated design space. The second section consisting of seven chapters present a range of thoroughly developed case studies in which the tools and methodologies discussed in the first section are used to support specific drug substance and drug-product QbD related developments. The last section discussed the needs for integrated tools and reviews the status of information technology tools available for systematic data and knowledge management to support QbD and related activities. Highlights Demonstrates Quality by Design (QbD) concepts through concrete detailed industrial case studies involving of the use of best practices and assessment of regulatory implications Chapters are devoted to applications of QbD methodology in three main processing sectors—drug substance process development, oral drug product manufacture, parenteral product processing, and solid-liquid processing Reviews the spectrum of process model types and their relevance, the range of state-of-the-art real-time monitoring tools and chemometrics, and alternative automatic process control strategies and methods for both batch and continuous processes The role of the design space is demonstrated through specific examples and the importance of understanding the risk management aspects of design space definition is highlighted Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture is an ideal book for practitioners, researchers, and graduate students involved in the development, research, or studying of a new drug and its associated manufacturing process.
Book Synopsis Design + Environment by : Helen Lewis
Download or read book Design + Environment written by Helen Lewis and published by Routledge. This book was released on 2017-09-08 with total page 229 pages. Available in PDF, EPUB and Kindle. Book excerpt: There is a huge scarcity of good, practical resources for designers and students interested in minimizing the environmental impacts of products. Design + Environment has been specifically written to address this paucity. The book first provides background information to help the reader understand how and why design for environment (DfE) has become so critical to design, with reference to some of the most influential writers, designers and companies in the field. Next, Design + Environment provides a step-by-step approach on how to approach DfE: to design a product that meets requirements for quality, cost, manufacturability and consumer appeal, while at the same time minimising environmental impacts. The first step in the process is to undertake an assessment of environmental impacts, using life-cycle assessment (LCA) or one of the many simpler tools available to help the designer. From then on, DfE becomes an integral part of the normal design process, including the development of concepts, design of prototypes, final design and development of marketing strategies. Environmental assessment tools and strategies to reduce environmental impacts, such as the selection of appropriate materials, are then discussed. Next, some of the links between environmental problems, such as global warming, ozone depletion, water and air pollution and the everyday products we consume are considered. In order to design products with minimal environmental impact, we need to have a basic understanding of these impacts and the interactions between them. The four subsequent chapters provide more detailed strategies and case studies for particular product groups: packaging, textiles, furniture, and electrical and electronic products. Guidelines are provided for each of the critical stages of a product's life, from the selection of raw materials through to strategies for recovery and recycling. Finally, Design + Environment takes a look at some of the emerging trends in DfE that are offering us the opportunity to make a more significant reduction in environmental impacts. Both the development of more sustainable materials and technologies and the growing interest in leasing rather than selling products are examined. Design + Environment is organized as a workbook rather than an academic text. It should be read once, and then used as a key reference source. This clear and informative book will prove to be invaluable to practising designers, to course directors and their students in need of a core teaching and reference text and to all those interested in learning about the tools and trends influencing green product design. The authors have all been involved in an innovative demonstration programme called "EcoReDesign", which was developed by the Centre for Design at RMIT University with funding from the Australian government. The Centre successfully collaborated with Australian companies to improve the environmental performance of their products by following DfE principles.
Book Synopsis Pharmaceutical Quality by Design by : Walkiria S. Schlindwein
Download or read book Pharmaceutical Quality by Design written by Walkiria S. Schlindwein and published by John Wiley & Sons. This book was released on 2018-01-05 with total page 319 pages. Available in PDF, EPUB and Kindle. Book excerpt: A practical guide to Quality by Design for pharmaceutical product development Pharmaceutical Quality by Design: A Practical Approach outlines a new and proven approach to pharmaceutical product development which is now being rolled out across the pharmaceutical industry internationally. Written by experts in the field, the text explores the QbD approach to product development. This innovative approach is based on the application of product and process understanding underpinned by a systematic methodology which can enable pharmaceutical companies to ensure that quality is built into the product. Familiarity with Quality by Design is essential for scientists working in the pharmaceutical industry. The authors take a practical approach and put the focus on the industrial aspects of the new QbD approach to pharmaceutical product development and manufacturing. The text covers quality risk management tools and analysis, applications of QbD to analytical methods, regulatory aspects, quality systems and knowledge management. In addition, the book explores the development and manufacture of drug substance and product, design of experiments, the role of excipients, multivariate analysis, and include several examples of applications of QbD in actual practice. This important resource: Covers the essential information about Quality by Design (QbD) that is at the heart of modern pharmaceutical development Puts the focus on the industrial aspects of the new QbD approach Includes several illustrative examples of applications of QbD in practice Offers advanced specialist topics that can be systematically applied to industry Pharmaceutical Quality by Design offers a guide to the principles and application of Quality by Design (QbD), the holistic approach to manufacturing that offers a complete understanding of the manufacturing processes involved, in order to yield consistent and high quality products.
Book Synopsis Handbook of Analytical Quality by Design by : Sarwar Beg
Download or read book Handbook of Analytical Quality by Design written by Sarwar Beg and published by Academic Press. This book was released on 2021-01-09 with total page 225 pages. Available in PDF, EPUB and Kindle. Book excerpt: Handbook of Analytical Quality by Design addresses the steps involved in analytical method development and validation in an effort to avoid quality crises in later stages. The AQbD approach significantly enhances method performance and robustness which are crucial during inter-laboratory studies and also affect the analytical lifecycle of the developed method. Sections cover sample preparation problems and the usefulness of the QbD concept involving Quality Risk Management (QRM), Design of Experiments (DoE) and Multivariate (MVT) Statistical Approaches to solve by optimizing the developed method, along with validation for different techniques like HPLC, UPLC, UFLC, LC-MS and electrophoresis. This will be an ideal resource for graduate students and professionals working in the pharmaceutical industry, analytical chemistry, regulatory agencies, and those in related academic fields. - Concise language for easy understanding of the novel and holistic concept - Covers key aspects of analytical development and validation - Provides a robust, flexible, operable range for an analytical method with greater excellence and regulatory compliance
Book Synopsis Introduction to Quality by Design (QbD) by : N. K. Jain
Download or read book Introduction to Quality by Design (QbD) written by N. K. Jain and published by Springer Nature. This book was released on with total page 505 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Juran on Quality by Design by : J. M. Juran
Download or read book Juran on Quality by Design written by J. M. Juran and published by Simon and Schuster. This book was released on 1992-05-04 with total page 552 pages. Available in PDF, EPUB and Kindle. Book excerpt: J.M. Juran, whom Business Week calls, "the man who taught Japan how to manage for quality", presents a new, exhaustively comprehensive approach to planning, setting, and reaching goals in Juran's Quality Road Map. New emphasis is placed on setting goals, planning in "multifunctional" processes, establishing data bases, motivating managers and introducing quality planning into organizations. 30 line drawings.
Book Synopsis Pharmaceutical Quality by Design Using JMP: Solving Product Development and Manufacturing Problems by : Rob Lievense
Download or read book Pharmaceutical Quality by Design Using JMP: Solving Product Development and Manufacturing Problems written by Rob Lievense and published by SAS Institute. This book was released on 2018-09 with total page 436 pages. Available in PDF, EPUB and Kindle. Book excerpt: Solve your pharmaceutical product development and manufacturing problems using JMP. Pharmaceutical Quality by Design Using JMP: Solving Product Development and Manufacturing Problems provides broad-based techniques available in JMP to visualize data and run statistical analyses for areas common in healthcare product manufacturing. As international regulatory agencies push the concept of Quality by Design (QbD), there is a growing emphasis to optimize the processing of products. This book uses practical examples from the pharmaceutical and medical device industries to illustrate easy-to-understand ways of incorporating QbD elements using JMP. Pharmaceutical Quality by Design Using JMP opens by demonstrating the easy navigation of JMP to visualize data through the distribution function and the graph builder and then highlights the following: the powerful dynamic nature of data visualization that enables users to be able to quickly extract meaningful information tools and techniques designed for the use of structured, multivariate sets of experiments examples of complex analysis unique to healthcare products such as particle size distributions/drug dissolution, stability of drug products over time, and blend uniformity/content uniformity. Scientists, engineers, and technicians involved throughout the pharmaceutical and medical device product life cycles will find this book invaluable.
Book Synopsis Quality by Design for Biopharmaceutical Drug Product Development by : Feroz Jameel
Download or read book Quality by Design for Biopharmaceutical Drug Product Development written by Feroz Jameel and published by Springer. This book was released on 2015-04-01 with total page 710 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume explores the application of Quality by Design (QbD) to biopharmaceutical drug product development. Twenty-eight comprehensive chapters cover dosage forms, liquid and lyophilized drug products. The introductory chapters of this book define key elements of QbD and examine how these elements are integrated into drug product development. These chapters also discuss lessons learned from the FDA Office of Biotechnology Products pilot program. Following chapters demonstrate how QbD is used for formulation development ranging from screening of formulations to developability assessment to development of lyophilized and liquid formats. The next few chapters study the use of small-scale and surrogate models as well as QbD application to drug product processes such as drug substance freezing and thawing, mixing, sterile filtration, filling, lyophilization, inspection and shipping and handling. Later chapters describe more specialized applications of QbD in the drug product realm. This includes the use of QbD in primary containers, devices and combination product development. The volume also explores QbD applied to vaccine development, automation, mathematical modeling and monitoring, and controlling processes and defining control strategies. It concludes with a discussion on the application of QbD to drug product technology transfer as well as overall regulatory considerations and lifecycle management. Quality by Design for Biopharmaceutical Drug Product Development is an authoritative resource for scientists and researchers interested in expanding their knowledge on QbD principles and uses in creating better drugs.
Book Synopsis Quality By Design by : Eugene C. Nelson
Download or read book Quality By Design written by Eugene C. Nelson and published by John Wiley & Sons. This book was released on 2011-01-14 with total page 507 pages. Available in PDF, EPUB and Kindle. Book excerpt: Quality by Design reflects the research and applied training conducted at Dartmouth Medical School under the leadership of Gene Nelson, Paul Batalden, and Marjorie Godfrey. The book includes the research results of high-performing clinical microsystems, illustrative case studies that highlight individual clinical programs, guiding principles that are easily applied, and tools, techniques, and methods that can be adapted by clinical practices and interdisciplinary clinical teams. The authors describe how to develop microsystems that can attain peak performance through active engagement of interdisciplinary teams in learning and applying improvement science and measurement; explore the essence of leadership for clinical Microsystems; show what mid-level leaders can do to enable peak performance at the front lines of care; outline the design and redesign of services and planning care to match patient needs with services offered; examine the issue of safety; describe the vital role of data in creating a rich and useful information environment; provide a core curriculum that can build microsystems’ capability, provide excellent care, promote a positive work environment, and contribute to the larger organization. Ancillary materials for use in classroom teaching, training, or coaching are available at https://clinicalmicrosystem.org/
Book Synopsis Quality by Design for Biopharmaceuticals by : Anurag S. Rathore
Download or read book Quality by Design for Biopharmaceuticals written by Anurag S. Rathore and published by John Wiley & Sons. This book was released on 2011-09-20 with total page 279 pages. Available in PDF, EPUB and Kindle. Book excerpt: The concepts, applications, and practical issues of Quality by Design Quality by Design (QbD) is a new framework currently being implemented by the FDA, as well as EU and Japanese regulatory agencies, to ensure better understanding of the process so as to yield a consistent and high-quality pharmaceutical product. QbD breaks from past approaches in assuming that drug quality cannot be tested into products; rather, it must be built into every step of the product creation process. Quality by Design: Perspectives and Case Studies presents the first systematic approach to QbD in the biotech industry. A comprehensive resource, it combines an in-depth explanation of basic concepts with real-life case studies that illustrate the practical aspects of QbD implementation. In this single source, leading authorities from the biotechnology industry and the FDA discuss such topics as: The understanding and development of the product's critical quality attributes (CQA) Development of the design space for a manufacturing process How to employ QbD to design a formulation process Raw material analysis and control strategy for QbD Process Analytical Technology (PAT) and how it relates to QbD Relevant PAT tools and applications for the pharmaceutical industry The uses of risk assessment and management in QbD Filing QbD information in regulatory documents The application of multivariate data analysis (MVDA) to QbD Filled with vivid case studies that illustrate QbD at work in companies today, Quality by Design is a core reference for scientists in the biopharmaceutical industry, regulatory agencies, and students.
Download or read book By Design 2 written by and published by . This book was released on 1989 with total page 290 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Quality by Design by : Lance A. Ealey
Download or read book Quality by Design written by Lance A. Ealey and published by . This book was released on 1988 with total page 368 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :Library of Congress. Copyright Office Publisher :Copyright Office, Library of Congress ISBN 13 : Total Pages :1624 pages Book Rating :4.F/5 ( download)
Book Synopsis Catalog of Copyright Entries. Third Series by : Library of Congress. Copyright Office
Download or read book Catalog of Copyright Entries. Third Series written by Library of Congress. Copyright Office and published by Copyright Office, Library of Congress. This book was released on 1977 with total page 1624 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :University of North Carolina at Chapel Hill. Center for Urban and Regional Studies Publisher : ISBN 13 : Total Pages :492 pages Book Rating :4.:/5 (3 download)
Book Synopsis Promoting Environmental Quality Through Urban Planning and Controls by : University of North Carolina at Chapel Hill. Center for Urban and Regional Studies
Download or read book Promoting Environmental Quality Through Urban Planning and Controls written by University of North Carolina at Chapel Hill. Center for Urban and Regional Studies and published by . This book was released on 1973 with total page 492 pages. Available in PDF, EPUB and Kindle. Book excerpt:
