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Validation De Procedes De Nettoyage Qualification Des Equipements Validation De Procedes De Fabrication
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Book Synopsis Guideline on General Principles of Process Validation by :
Download or read book Guideline on General Principles of Process Validation written by and published by . This book was released on 1987 with total page 32 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Manual on Quality Assurance Programme Auditing by : International Atomic Energy Agency
Download or read book Manual on Quality Assurance Programme Auditing written by International Atomic Energy Agency and published by Bernan Press(PA). This book was released on 1984 with total page 174 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Culture | 2030 indicators by : UNESCO
Download or read book Culture | 2030 indicators written by UNESCO and published by UNESCO Publishing. This book was released on 2019-11-18 with total page 112 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Knowing our lands and resources by : Roué, Marie
Download or read book Knowing our lands and resources written by Roué, Marie and published by UNESCO Publishing. This book was released on 2017-04-03 with total page 150 pages. Available in PDF, EPUB and Kindle. Book excerpt:
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 Biocontamination Control for Pharmaceuticals and Healthcare by : Tim Sandle
Download or read book Biocontamination Control for Pharmaceuticals and Healthcare written by Tim Sandle and published by Elsevier. This book was released on 2024-01-28 with total page 510 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biocontamination Control for Pharmaceuticals and Healthcare outlines a biocontamination strategy that tracks bio-burden control and reduction at each transition in classified areas of a facility. The first edition of the book covered many of the aspects of the strategy, but the new official guidance signals that a roadmap is required to fully comply with its requirements. Completely updated with the newest version of the EU-GPM (EN17141) the new edition expands the coverage of quality risk management and new complete examples to help professionals bridge the gap between regulation and implementation. Biocontamination Control for Pharmaceuticals and Healthcare offers professionals in pharma quality control and related areas guidance on building a complete biocontamination strategy. - Includes the most current regulations - Contains three new chapters, including Application of Quality Risk Management and its Application in Biocontamination Control, Designing an Environmental Monitoring Programme, and Synthesis: An Anatomy of a Contamination Control Strategy - Offers practical guidance on building a complete biocontamination strategy
Book Synopsis Disaster risk reduction in school curricula: case studies from thirty countries by :
Download or read book Disaster risk reduction in school curricula: case studies from thirty countries written by and published by UNESCO. This book was released on 2012 with total page 209 pages. Available in PDF, EPUB and Kindle. Book excerpt:
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 Preparative Layer Chromatography by : Teresa Kowalska
Download or read book Preparative Layer Chromatography written by Teresa Kowalska and published by CRC Press. This book was released on 2006-02-03 with total page 441 pages. Available in PDF, EPUB and Kindle. Book excerpt: Preparative Layer Chromatography explains how this method is used for separating large quantities of mixtures containing a wide variety of important compounds. It offers a broad review of preparative layer chromatography (PLC) applications and adaptable working procedures for microseparations involving organic, inorganic, and organometallic compoun
Download or read book Dairy Technology written by P. Walstra and published by CRC Press. This book was released on 1999-04-23 with total page 752 pages. Available in PDF, EPUB and Kindle. Book excerpt: Describes the efficient transformation of milk into a variety of products, focusing on the changes in raw material, and intermediate and final products, as well as the interactions between products and processing equipment. The book details the procedures for ensuring processing efficiency and product quality.
Book Synopsis Traditional Mediterranean Architecture by : Amin Maalouf
Download or read book Traditional Mediterranean Architecture written by Amin Maalouf and published by . This book was released on 2002 with total page 139 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Child Friendly Schools Manual written by and published by UNICEF. This book was released on 2009 with total page 244 pages. Available in PDF, EPUB and Kindle. Book excerpt: This Child-Friendly Schools (CFS) Manual was developed during three-and-a-half years of continuous work, involving the United Nations Children's Fund education staff and specialists from partner agencies working on quality education. It benefits from fieldwork in 155 countries and territories, evaluations carried out by the Regional Offices and desk reviews conducted by headquarters in New York. The manual is a part of a total resource package that includes an e-learning package for capacity-building in the use of CFS models and a collection of field case studies to illustrate the state of the art in child-friendly schools in a variety of settings.
Book Synopsis Gas-cooled Nuclear Reactors by : France. Commissariat à l'énergie atomique
Download or read book Gas-cooled Nuclear Reactors written by France. Commissariat à l'énergie atomique and published by . This book was released on 2006 with total page 192 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Collected Essays in Architectural Criticism by : Alan Colquhoun
Download or read book Collected Essays in Architectural Criticism written by Alan Colquhoun and published by Black Dog Architecture. This book was released on 2009 with total page 358 pages. Available in PDF, EPUB and Kindle. Book excerpt: Collected Essays in Architectural Criticism is an indispensable anthology of writing by one of the most important voices in architectural theory of the last 50 years. Born in 1921, Colquhoun graduated from the Architectural Association in 1949. Currently Professor Emeritus of Architecture at Princeton University, he has taught at the AA, Cornell University and University College Dublin, among many other schools of architecture. He is the author of several books including the seminal Essays in Architectural Criticism, 1981, Modernity and the Classical Tradition, 1991, (both republished here in their entirety) and The Oxford History of Modern Architecture, 2002. This book includes essays from throughout Colquhoun's distinguished career. In his early writing Colquhoun subjects modern architecture to a far more thorough reading than was then customary. His meticulous evaluation of Modernism raised the standard of architectural historiography and has influenced new directions in theory and practice ever since. Collected Essays in Architectural Criticism encompasses the clarity of style and rigorous, erudite analysis that Colquhoun has brought to bear on a diverse range of subjects, including Le Corbusier, Robert Venturi and Denise Scott Brown, the Pompidou Centre, Postmodernism and the design of museums.
Book Synopsis Enterobacter Sakazakii and Other Microorganisms in Powdered Infant Formula by :
Download or read book Enterobacter Sakazakii and Other Microorganisms in Powdered Infant Formula written by and published by Food & Agriculture Org. This book was released on 2004 with total page 59 pages. Available in PDF, EPUB and Kindle. Book excerpt: Jointly issued by the World Health Organization and the Food and Agriculture Organization. This publication contains the findings of an FAO/WHO expert meeting, held in Geneva in February 2004.
Book Synopsis La validation intégrée by : Daniel Mouton
Download or read book La validation intégrée written by Daniel Mouton and published by Dunod. This book was released on 2008-06-11 with total page 226 pages. Available in PDF, EPUB and Kindle. Book excerpt: Cet ouvrage porte sur la méthodologie de la validation. Le terme de validation est utilisé pour décrire un processus visant à démontrer qu'un produit (application informatique, outil de production industriel, procédé de fabrication, etc.) apporte les fonctions et les performances requises par le client et la réglementation. Avant de valider le produit, le client le compare avec les spécifications de son besoin en s'appuyant sur des résulats de tests et des documentations associées. Cette validation repose sur une participation active et constructive du client mais aussi sur la mise en oeuvre des processus qualité : c'est la validation intégrée. Pratique et complet, ce livre donne toutes les informations nécessaires au débutant pour devenir opérationnel, au chef de projet pour comprendre et intéger la problématique de la validation dans le déroulement du projet.
Book Synopsis La méthode de calcul des Limites Résiduelles Acceptables : un pilier de l'optimisation de la stratégie de la validation de nettoyage dans l'industrie pharmaceutique by : Fanny Dupuy
Download or read book La méthode de calcul des Limites Résiduelles Acceptables : un pilier de l'optimisation de la stratégie de la validation de nettoyage dans l'industrie pharmaceutique written by Fanny Dupuy and published by . This book was released on 2024 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Dans l'industrie pharmaceutique, le nettoyage représente un pilier fondamental dans la lutte contre les contaminations des produits fabriqués. Afin d'évaluer l'efficacité de cette opération la stratégie de validation de nettoyage est particulièrement importante. Cela passe notamment par le choix de seuils d'acceptation adaptés et pertinents (prise en compte de la Permitted Daily Exposure (PDE), de la surface réelle des équipements...). Ce travail expose donc dans un premier temps, les différents modes de contamination et les différents moyens mis en œuvre pour les éviter. Puis, il détaille les pré requis à la validation de nettoyage ainsi que ses diverses étapes. Pour finir, il présente un exemple concret d'optimisation de stratégie de validation de nettoyage via le calcul de nouvelles Limites Résiduelles Acceptables (LRA) et le choix de nouveaux critères d'acceptation.