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
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.
Download or read book How to Integrate Quality by Efficient Design QbED in Product Development written by Bhavishya Mittal and published by Academic Press. This book was released on 2019-08-24 with total page 276 pages. Available in PDF, EPUB and Kindle. Book excerpt: The development of a robust drug product requires juggling many competing priorities such as overcoming scientific challenges, following regulatory requirements, and managing business-related concerns. Unfortunately, despite large resources spent on R&D, multifactor productivity of pharmaceuticals is on the decline for several years now. Because of this business reality, pharmaceutical companies have seen a notable change in the traditional operating model and footprint over the past couple of decades. Outsourcing, in particular, has emerged as a successful business model for many pharmaceutical companies looking for ways to strategically increase their R&D capabilities and to augment their in-house resources. How to Integrate Quality by Efficient Design (QbED) in Product Development bridges the gap between theory and practice when it comes to strategic decision-making in a pharmaceutical research scenario. This book will introduce the concept of QbED and focus on various aspects such as patient-centric product designs, platform-based manufacturing technologies, business acuity, and regulatory strategies to balance the challenges in outsourcing with the need for strategic and statistically sound experiments rooted in good science. Detailed discussions will cover pharmaceutical business models, regulatory approval process, quality by design (QbD), business analytics, and manufacturing excellence specifically for small molecules and solid oral dosage forms. With the addition of case studies, flowcharts, diagrams, and data visualizations, How to Integrate Quality by Efficient Design (QbED) in Product Development will be a practical reference to help professionals working in the area of pharmaceutical drug development, strategy, and outsourcing management. - Part of the Expertise in Pharmaceutical Process Technology series edited by Michael Levin - Integrates pharmaceutical business models, economics, and outsourcing-related challenges into pharmaceutical product development - Discusses relevant literature references in quality risk management, business strategy, QbD, and product development - Provides decision-making flowcharts, conceptual diagrams, and data visualizations to make the book useful, easy to read, and to understand
Download or read book Quality Through Design written by N. Logothetis and published by Oxford University Press, USA. This book was released on 1994 with total page 486 pages. Available in PDF, EPUB and Kindle. Book excerpt: The main purpose of this book is to encourage the proper implementation of the techniques which have contributed to Japan's industrial success. Designing for quality is the next evolutionary stage in quality systems, a stage that industries need to embrace.
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
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.
Download or read book Quality Through Design written by John Fox and published by McGraw-Hill Companies. This book was released on 1993 with total page 248 pages. Available in PDF, EPUB and Kindle. Book excerpt: Focuses on the concept of managing the critical functional parameters of a design and explains how these functional aspects can be evaluated prior to testing. It shows how, through monitoring the quality of a product throughout its life-cycle, the sequence of "design-build-test" could be reduced.
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.
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/
Download or read book Quality by Experimental Design written by Thomas B. Barker and published by CRC Press. This book was released on 2016-01-27 with total page 740 pages. Available in PDF, EPUB and Kindle. Book excerpt: Achieve Technological Advancements in Applied Science and Engineering Using Efficient Experiments That Consume the Least Amount of ResourcesWritten by longtime experimental design guru Thomas B. Barker and experimental development/Six Sigma expert Andrew Milivojevich, Quality by Experimental Design, Fourth Edition shows how to design and analyze ex
Download or read book Pharmaceutical Quality by Design Using JMP written by Rob Lievense and published by . This book was released on 2018-10 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. This book is part of the SAS Press program.
Download or read book Housing Design Quality written by Matthew Carmona and published by Taylor & Francis. This book was released on 2002-01-04 with total page 360 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book directly addresses the major planning debate of our time - the delivery and quality of new housing development. As pressure for new housing development in England increases, a widespread desire to improve the design of the resulting residential environments becomes evermore apparent with increasing condemnation of the standard products of the volume housebuilders. In recent years central government has come to accept the need to deliver higher quality living environments, and the important role of the planning system in helping to raise design standards. Housing Design Quality focuses on this role and in particular on how the various policy instruments available to public authorities can be used in a positive manner to deliver higher quality residential developments.
Download or read book The Understanding by Design Guide to Creating High Quality Units written by Grant Wiggins and published by ASCD. This book was released on 2011-03-11 with total page 139 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Understanding by Design Guide to Creating High-Quality Units offers instructional modules on the basic concepts and elements of Understanding by Design (UbD), the "backward design" approach used by thousands of educators to create curriculum units and assessments that focus on developing students' understanding of important ideas. The eight modules are organized around the UbD Template Version 2.0 and feature components similar to what is typically provided in a UbD design workshop, including— * Discussion and explanation of key ideas in the module; * Guiding exercises, worksheets, and design tips; * Examples of unit designs; * Review criteria with prompts for self-assessment; and * A list of resources for further information. This guide is intended for K-16 educators—either individuals or groups—who may have received some training in UbD and want to continue their work independently; those who've read Understanding by Design and want to design curriculum units but have no access to formal training; graduate and undergraduate students in university curriculum courses; and school and district administrators, curriculum directors, and others who facilitate UbD work with staff. Users can go through the modules in sequence or skip around, depending on their previous experience with UbD and their preferred curriculum design style or approach. Unit creation, planning, and adaptation are easier than ever with the accompanying downloadable resources, including the UbD template set up as a fillable PDF form, additional worksheets, examples, and FAQs about the module topics that speak to UbD novices and veterans alike.
Download or read book Quality through design written by N. Logothetis and published by . This book was released on 1994 with total page 464 pages. Available in PDF, EPUB and Kindle. Book excerpt:
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 Multivariate Analysis in the Pharmaceutical Industry written by Ana Patricia Ferreira and published by Academic Press. This book was released on 2018-04-24 with total page 465 pages. Available in PDF, EPUB and Kindle. Book excerpt: Multivariate Analysis in the Pharmaceutical Industry provides industry practitioners with guidance on multivariate data methods and their applications over the lifecycle of a pharmaceutical product, from process development, to routine manufacturing, focusing on the challenges specific to each step. It includes an overview of regulatory guidance specific to the use of these methods, along with perspectives on the applications of these methods that allow for testing, monitoring and controlling products and processes. The book seeks to put multivariate analysis into a pharmaceutical context for the benefit of pharmaceutical practitioners, potential practitioners, managers and regulators. Users will find a resources that addresses an unmet need on how pharmaceutical industry professionals can extract value from data that is routinely collected on products and processes, especially as these techniques become more widely used, and ultimately, expected by regulators. - Targets pharmaceutical industry practitioners and regulatory staff by addressing industry specific challenges - Includes case studies from different pharmaceutical companies and across product lifecycle of to introduce readers to the breadth of applications - Contains information on the current regulatory framework which will shape how multivariate analysis (MVA) is used in years to come
Download or read book Total Quality Project Management for the Design Firm written by Frank A. Stasiowski and published by John Wiley & Sons. This book was released on 1993-12-16 with total page 418 pages. Available in PDF, EPUB and Kindle. Book excerpt: Staying Small Successfully A Guide for Architects, Engineers, and Design Professionals Frank A. Stasiowski Today's design professional with entrepreneurial ambitions often has in mind a small firm. Written by a veteran architect and consultant, here is a clear, detailed road map to setting up a small business or guiding an existing one to success. Using miniprofiles of several small successful design firms, the author pinpoints exactly what's made them flourish. In a step-by-step format, he describes the six elements of the strategic planning process, tips on doubling average profit levels, building a loyal clientele, making your company a magnet for top talent, as well as measuring the financial health of your firm. This all-in-one seminar includes numerous checklists and flowcharts, a list of design firm management consultants, a typical marketing plan, and a survey of typical marketing costs. 1991 (0-471-50652-4) 297 pp. Value Pricing for the Design Firm Frank A. Stasiowski Essential to the design firm negotiating tough economic times, here is a handbook to garnering the most effective price for your services. Making the traditional cost-per-hour approach obsolete, the book teaches you how to price services based on their value to your client. Full of tactics that can be applied immediately, the book outlines the different methods of value pricing, ways to create value, a format for charging minimum fees, and a formula for price contracts. Other practical pricing tips include mini-scoping your services, charging for reimbursables, pricing change orders, as well as advice on negotiating a better contract. Complete with sample forms and lists, the book is a practical, easy-to-implement recession survival kit for the design firm. 1993 (0-471-57933-5) 240 pp. Cash Management for the Design Firm Frank A. Stasiowski While excellence in design and engineering may generate clients, monitoring and planning the movement of cash is central to a company's survival. This practical guide outlines a det!ailed cash management plan that makes continued financial health possible even during lean economic times. Using a clear, easy-to-implement approach, the book describes: cash management techniques, project budgeting, profitable project pricing structures, controlling project and overhead costs, getting paid, and planning and monitoring performance. The book also includes valuable advice on negotiating a contract, the most profitable contract types, the purchasing process, acquiring capital equipment, and internal financial controls. Numerous checklists and exercises as well as sample reports and financial documents are included. 1993 (0-471-59711-2) 324 pp.
