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Evolution De La Demarche De Qualification Commissioning Et Validation Dans Lindustrie Pharmaceutique
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Book Synopsis Single-Use Technology in Biopharmaceutical Manufacture by : Regine Eibl
Download or read book Single-Use Technology in Biopharmaceutical Manufacture written by Regine Eibl and published by John Wiley & Sons. This book was released on 2019-07-18 with total page 367 pages. Available in PDF, EPUB and Kindle. Book excerpt: Authoritative guide to the principles, characteristics, engineering aspects, economics, and applications of disposables in the manufacture of biopharmaceuticals The revised and updated second edition of Single-Use Technology in Biopharmaceutical Manufacture offers a comprehensive examination of the most-commonly used disposables in the manufacture of biopharmaceuticals. The authors—noted experts on the topic—provide the essential information on the principles, characteristics, engineering aspects, economics, and applications. This authoritative guide contains the basic knowledge and information about disposable equipment. The author also discusses biopharmaceuticals’ applications through the lens of case studies that clearly illustrate the role of manufacturing, quality assurance, and environmental influences. This updated second edition revises existing information with recent developments that have taken place since the first edition was published. The book also presents the latest advances in the field of single-use technology and explores topics including applying single-use devices for microorganisms, human mesenchymal stem cells, and T-cells. This important book: • Contains an updated and end-to-end view of the development and manufacturing of single-use biologics • Helps in the identification of appropriate disposables and relevant vendors • Offers illustrative case studies that examine manufacturing, quality assurance, and environmental influences • Includes updated coverage on cross-functional/transversal dependencies, significant improvements made by suppliers, and the successful application of the single-use technologies Written for biopharmaceutical manufacturers, process developers, and biological and chemical engineers, Single-Use Technology in Biopharmaceutical Manufacture, 2nd Edition provides the information needed for professionals to come to an easier decision for or against disposable alternatives and to choose the appropriate system.
Book Synopsis Continuous Biomanufacturing by : Ganapathy Subramanian
Download or read book Continuous Biomanufacturing written by Ganapathy Subramanian and published by John Wiley & Sons. This book was released on 2017-12-26 with total page 628 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is the most comprehensive treatise of this topic available, providing invaluable information on the technological and economic benefits to be gained from implementing continuous processes in the biopharmaceutical industry. Top experts from industry and academia cover the latest technical developments in the field, describing the use of single-use technologies alongside perfusion production platforms and downstream operations. Special emphasis is given to process control and monitoring, including such topics as 'quality by design' and automation. The book is supplemented by case studies that highlight the enormous potential of continuous manufacturing for biopharmaceutical production facilities.
Book Synopsis Cost Planning of PFI and PPP Building Projects by : Abdelhalim Boussabaine
Download or read book Cost Planning of PFI and PPP Building Projects written by Abdelhalim Boussabaine and published by Routledge. This book was released on 2013-04-03 with total page 336 pages. Available in PDF, EPUB and Kindle. Book excerpt: This topical and timely book presents and innovative approach to dealing with the complexities of cost planning in PFI. PFI/PPP projects have a significantly different costing environment from conventionally procured projects, requiring cost analysts to use their expertise and innovative thinking to develop whole-life cost solutions that deliver value for money to the client, thus improving public building assets performance. Abdelhalim Boussabaine provides a thorough grounding in the theory of PFI, from its early evolution through to examples of current projects. In particular, the rationale for private financing of public services, arguments for and against PFI and 'value for money' mechanisms are discussed. The book presents an innovative framework for whole-life value and calls for changes in the way whole life cycle value is perceived, created and exchanged. Cost Planning of PFI and PPP Building Projects provides the reader with existing knowledge as well as present innovative thinking for future development and management of PFI/PPP cost planning processes. Given the importance and novelty of this book, academics, professionals, undergraduate and postgraduate students will find this book valuable.
Book Synopsis An Introduction to Building Procurement Systems by : Jack W.E. Masterman
Download or read book An Introduction to Building Procurement Systems written by Jack W.E. Masterman and published by Routledge. This book was released on 2003-09-02 with total page 152 pages. Available in PDF, EPUB and Kindle. Book excerpt: First Published in 2003. Routledge is an imprint of Taylor & Francis, an informa company.
Book Synopsis International Construction by : Mark Mawhinney
Download or read book International Construction written by Mark Mawhinney and published by John Wiley & Sons. This book was released on 2008-04-15 with total page 250 pages. Available in PDF, EPUB and Kindle. Book excerpt: A recent construction project in Singapore involved a Russian plant, a Japanese management team, Australian and Italian engineers, Thai steel workers and a labour force from throughout Asia ... The recent growth explosion of multi-nationals and the lowering of trade barriers is pushing the globalization of construction at a startling pace. Mark Mawhinney has brought together for the first time, advice, information and evidence on this developing arena from a wide range of sources. This book offers a clear understanding of the international construction market and an explanation of what knowledge is required to operate successfully in it. It also helps readers become familiar with some of the analytical tools available. Drawing on both contractor and consultant case studies and including a practical 'hints and signposts' section, International Construction provides a lively and informed introduction for construction professionals moving into international work.
Book Synopsis Procurement Strategies by : Derek Walker
Download or read book Procurement Strategies written by Derek Walker and published by John Wiley & Sons. This book was released on 2008-04-15 with total page 318 pages. Available in PDF, EPUB and Kindle. Book excerpt: Construction has been an industry characterised by disputes, fierce competitiveness and fragmentation - all major obstacles to development. Now, however, a relationship-based approach to project procurement, through partnering and alliancing, aims to bring about a fundamental change. This book addresses the critical relationship issues for a more collaborative and sustainable construction industry. It looks at how project procurement and project alliancing partner selection works, and how risk and crisis resolution are managed. It provides readers with guidance and models on how to put a relationship-based approach to procurement into practice, drawing on specific prototypes from an actual, successful project that can be adapted.
Book Synopsis Appropriate Technology for Developing Countries by : Willem Riedijk
Download or read book Appropriate Technology for Developing Countries written by Willem Riedijk and published by . This book was released on 1982 with total page 376 pages. Available in PDF, EPUB and Kindle. Book excerpt: Serious, capable and experienced people, engineers, scientists and managers cooperatimg with base groups in the field of appropiate technology. Thousands of projects run by hundreds of organisations, institutesand groups, worldwide. That is the picture of AT today. So many people, so much work, so much hardware, but little recognition. Somany novelties, so few implementations. Is it the lack of funding and the lack of quality related with it? I don't think so. In third world countries A.T. is often seen as second best, even as a form of neocolonialism.
Book Synopsis Managing Architectural Projects by : David S. Haviland
Download or read book Managing Architectural Projects written by David S. Haviland and published by . This book was released on 1984 with total page 134 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis The Idea of Building by : Steven Groak
Download or read book The Idea of Building written by Steven Groak and published by Taylor & Francis. This book was released on 2002-09-11 with total page 268 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is unique in its attempt to explore the many ways we have of thinking about buildings. In particular it raises questions about the kinds of knowledge we have and will need in designing, making and enjoying our buildings. At the very least this book provides an overview of the fragmented construction industry, making it a vital purchase for all construction related students. However, the author has written for a wider audience making the book an essential guide for those interested in the form of buildings or the deliberate ways in which people build them.
Book Synopsis Managing Overseas Construction Contracting by : D. A. Langford
Download or read book Managing Overseas Construction Contracting written by D. A. Langford and published by Thomas Telford. This book was released on 1995 with total page 204 pages. Available in PDF, EPUB and Kindle. Book excerpt: Increasingly, more and more clients are seeking to procure construction work on a global basis; designers from one country, contractors from another, materials and subcontractors from yet others. In such a complex multi-organisational and cross-cultural setting, the management of the construction environment and process is likely to create a formidable challenge. Managing overseas construction contracting addresses these challenges and provides practical guidance on the best approaches to take to ensure the best results. The book will be of benefit and interest to all professional practitioners in construction and finance who are currently involved in, or planning to be involved in, overseas construction. It will also be of particular interest to undergraduates and graduates with an interest in overseas construction, who are specialising in the built environment, development economics or project management. The book has been divided into five parts, with each part addressing a particular element of the international construction process: Part I analyses the range of stakeholders that a company will need to satisfy. This includes both internal stakeholders - such as employees) and external stakeholders - such as subcontractors and suppliers). Part II explores the marketing process. This section has been broken down into three themes: marketing strategy, market evaluation and marketing tactics. Part III looks at the task necessary in the successful execution of the construction project. It begins by reviewing the project plan and how the diverse resources of labour, subcontractors, plant, equipment and materials are procured, brought to site and incorporated into the works. This section also looks at project management including, how staff are motivated, how quality is maintained and how safe working is assured. Part IV takes stock of the process of international contracting by reviewing the characteristics of firms which operate in overseas settings. Part V provides two in-depth case studies which describe the project processes involved in the construction of a major irrigation scheme and a massive port development.
Book Synopsis Strategic Management in Construction by : David Langford
Download or read book Strategic Management in Construction written by David Langford and published by John Wiley & Sons. This book was released on 2008-04-15 with total page 258 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book reviews the general theory of strategy, relates it to the particular circumstances of the construction industry, and shows how it can be applied in practice. It brings together ideas from economics, marketing, management, business and politics to develop strategic management for both contractors' firms and the associated professions. Substantial changes have occurred in the industry since the book was first published in 1991. This Second Edition reflects the major developments that have followed the Latham and Egan reports, and includes new chapters on international strategy and marketing, showing how they can contribute to the strategic planning of construction organizations. The book will provide a valuable tool for the strategic development of construction firms. "Ten years separate the editions during which period a significant number of British, (and other), construction firms which had survived generations of proprietors merged, changed beyond recognition or ceased trading. One can not but wonder if publication of a work on strategic planning some twenty year earlier might have saved some of them." Construction Manager "The book presents the essential elements for managing at this higher level and should be a must for any construction professional who aspires to an executive position in industry as well as any student for construction management, project management and organizational management in construction. It comes highly recommended" Engineering, Construction and Architectural Management
Book Synopsis Equipment Qualification in the Pharmaceutical Industry by : Steven Ostrove
Download or read book Equipment Qualification in the Pharmaceutical Industry written by Steven Ostrove and published by Academic Press. This book was released on 2019-06-13 with total page 236 pages. Available in PDF, EPUB and Kindle. Book excerpt: Equipment Qualification in the Pharmaceutical Industry provides guidance and basic information for the preparation of a quality qualification program. It has been noted that there is a general lack of understanding in the industry, especially for those new to the industry, as to what constitutes a compliant qualification program. Even experienced professionals have felt a lack of security in reaching a compliant state. This book outlines a guideline for the preparation and execution of qualification protocols including the installation (IQ), operational (OQ), and performance (PQ) protocols. It discusses the importance of related qualification programs (e.g., quality systems, commissioning, computer system, and cleaning) and how to incorporate them into a fully compliant qualification program. Furthermore, it provides matrices of what could be included in each type of protocol for major types of process equipment. While primarily for people entering the pharmaceutical industry, those established in the field will benefit from the multiple examples and matrices as well as integration of related systems. Equipment Qualification in the Pharmaceutical Industry provides students and pharmaceutical scientists a guideline for the preparation and execution of qualification (installation, operational, and performance) protocols. - Incorporates good manufacturing processes into a compliant qualification program - Provides examples of protocol layout - Includes matrices for major process equipment, installation quality, operational quality, and performance quality requirements
Book Synopsis Post-Disaster Reconstruction by : Matthew Clarke
Download or read book Post-Disaster Reconstruction written by Matthew Clarke and published by Earthscan. This book was released on 2010 with total page 284 pages. Available in PDF, EPUB and Kindle. Book excerpt: On Sunday 26 December 2004, a tsunami of up to 30 metres high hit the northern tip of Sumatera in Indonesia, causing immediate destruction and the deaths of at least 130,000 in Indonesia alone. The scale of the devastation and ensuing human suffering prompted the biggest response endeavour to any natural disaster in history.Post-Disaster Reconstruction will be the first major book that analyses the different perspectives and experiences of the enormous post-tsunami reconstruction effort. It looks specifically at the reconstruction efforts in Aceh, one of the regions most heavily-hit by the tsunami and a province that has until recently suffered nearly three decades of armed conflict. Positioning the reconstruction efforts within Aceh's multi-layered historical, cultural, socio-political and religious contexts, the authors explore diverse experiences and assessments of the reconstruction. It considers the importance of the political and religious settings of the reconstruction, the roles of communities and local non-government organisations and the challenges faced by Indonesian and international agencies. From the in-depth examination of this important case study of disaster reconstruction - significant not only because of the huge scale of the natural disaster and response but also the post-conflict issues - the editors draw together the lessons learned for the future of Aceh and make general recommendations for post-disaster and post-conflict reconstruction-making.
Book Synopsis Facility Validation by : Graham C. Wrigley
Download or read book Facility Validation written by Graham C. Wrigley and published by CRC Press. This book was released on 2004-03-29 with total page 160 pages. Available in PDF, EPUB and Kindle. Book excerpt: Often considered a necessary evil by the pharmaceutical industry, validation is still understood by many as unrestrained bureaucracy, paperwork, and procedures whose roots and logic are obscure and only serve to slow down progress. Thoroughly defining the philosophy, application, and processes, Facility Validation: Theory, Practice, and Tools explores the validation issues relevant to the start-up of a new or upgraded manufacturing facility. The author describes policies, guidelines, and regulations relating to GMPs in the pharmaceutical industry and explores the relationship between these GMPs and the validation process. He outlines the theory and clarifies the philosophy and key principles of validation such as life-cycle approach and qualification practices. The book includes coverage of common pitfalls and how to avoid them, the difficulties and constraints a validation team has to manage, and the dangers of not adopting and following the recommended best practices. Facility validation has, in fact, become good business. It can be a tool for enhancing reliability, cost, and quality. This book makes the case that design, engineering, commissioning, and validation activities can be integrated and streamlined to accelerate a pharmaceutical manufacturing plant start-up effort, and demonstrates how to use best practices to achieve the results you desire in your organization.
