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Author: Molyvanh Chitranonh
Publisher:
ISBN:
Category :
Languages : fr
Pages :
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Book Description
La production des vaccins est un processus biologique complexe nécessitant un très haut niveau d'expertise. Le processus de production doit s'adapter continuellement pour répondre à l'évolution des exigences réglementaires qui varient d'un pays à l'autre. Ces vaccins sont encadrés par de nombreux requis et référentiels réglementaires. La conformité à l'ensemble de ces requis doit être maîtrisée par l'entreprise pharmaceutique à travers un système qualité adapté, afin de garantir l'efficacité et la qualité des produits mis sur le marché et ainsi assurer la sécurité du patient.Dans le cadre de la production du vaccin, des écarts qualité - dits « déviations » ou « anomalies » - en cours de production peuvent survenir. L'impact des anomalies sur la production de vaccin est non négligeable. Les anomalies en cours de production peuvent entrainer des retards sur la chaine de production, des retards sur l'approvisionnement du vaccin, des rejets de lots voire des rappels de lots dans les cas les plus critiques. Ce document introduit les notions générales du vaccin et l'industrie du vaccin, puis de la gestion de la qualité en industrie pharmaceutique et son contexte réglementaire. Ensuite, il présente le processus de traitement d'une anomalie et les moyens mis en œuvre pour permettre la résolution de ce dernier grâce à l'utilisation d'outils qualité. Les investigations liées à ces écarts qualité sont primordiales pour découvrir la cause racine à l'origine du problème, et pour apporter des solutions de remédiation nécessaires afin d'éviter leur récurrence et sécuriser les produits.La dernière partie détaillera les différentes clés de succès pour une bonne gestion des anomalies dans un service de production, tel que l'importance du suivi des indicateurs, le pilotage et la standardisation des pratiques. Cette partie est en corrélation directe avec la mise en place d'un système de management de la qualité efficace de l'entreprise pharmaceutique.
Author: Molyvanh Chitranonh
Publisher:
ISBN:
Category :
Languages : fr
Pages :
Get Book Here
Book Description
La production des vaccins est un processus biologique complexe nécessitant un très haut niveau d'expertise. Le processus de production doit s'adapter continuellement pour répondre à l'évolution des exigences réglementaires qui varient d'un pays à l'autre. Ces vaccins sont encadrés par de nombreux requis et référentiels réglementaires. La conformité à l'ensemble de ces requis doit être maîtrisée par l'entreprise pharmaceutique à travers un système qualité adapté, afin de garantir l'efficacité et la qualité des produits mis sur le marché et ainsi assurer la sécurité du patient.Dans le cadre de la production du vaccin, des écarts qualité - dits « déviations » ou « anomalies » - en cours de production peuvent survenir. L'impact des anomalies sur la production de vaccin est non négligeable. Les anomalies en cours de production peuvent entrainer des retards sur la chaine de production, des retards sur l'approvisionnement du vaccin, des rejets de lots voire des rappels de lots dans les cas les plus critiques. Ce document introduit les notions générales du vaccin et l'industrie du vaccin, puis de la gestion de la qualité en industrie pharmaceutique et son contexte réglementaire. Ensuite, il présente le processus de traitement d'une anomalie et les moyens mis en œuvre pour permettre la résolution de ce dernier grâce à l'utilisation d'outils qualité. Les investigations liées à ces écarts qualité sont primordiales pour découvrir la cause racine à l'origine du problème, et pour apporter des solutions de remédiation nécessaires afin d'éviter leur récurrence et sécuriser les produits.La dernière partie détaillera les différentes clés de succès pour une bonne gestion des anomalies dans un service de production, tel que l'importance du suivi des indicateurs, le pilotage et la standardisation des pratiques. Cette partie est en corrélation directe avec la mise en place d'un système de management de la qualité efficace de l'entreprise pharmaceutique.
Author: Alan D. Lopez
Publisher: World Bank Publications
ISBN: 0821362631
Category : Medical
Languages : en
Pages : 511
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Book Description
Strategic health planning, the cornerstone of initiatives designed to achieve health improvement goals around the world, requires an understanding of the comparative burden of diseases and injuries, their corresponding risk factors and the likely effects of invervention options. The Global Burden of Disease framework, originally published in 1990, has been widely adopted as the preferred method for health accounting and has become the standard to guide the setting of health research priorities. This publication sets out an updated assessment of the situation, with an analysis of trends observed since 1990 and a chapter on the sensitivity of GBD estimates to various sources of uncertainty in methods and data.
Author: Archie Hunter
Publisher: CTA; MacMillan
ISBN: 9780333612026
Category : Animal health
Languages : en
Pages : 167
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Book Description
Animal Health Volume 1 is a practical guide for anyone involved with maintaining and establishing the health of animals in tropical and sub-tropical regions. It comprehensively explains the causes of animal diseases, how they spread and the means available for their control. The handbook should be used in conjunction with Volume 2: Specific Diseases which is already published.
Author: Henry Mintzberg
Publisher: Berrett-Koehler Publishers
ISBN: 1626563195
Category : Political Science
Languages : en
Pages : 166
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Book Description
Enough of the imbalance that is causing the degradation of our environment, the demise of our democracies, and the denigration of ourselves. Enough of the pendulum politics of left and right and paralysis in the political center. We require an unprecedented form of radical renewal. In this book Henry Mintzberg offers a new understanding of the root of our current crisis and a strategy for restoring the balance so vital to the survival of our progeny and our planet. With the collapse of the communist regimes of Eastern Europe, Western pundits declared that capitalism had triumphed. They were wrong—balance triumphed. A healthy society balances a public sector of respected governments, a private sector of responsible businesses, and a plural sector of robust communities. Communism collapsed under the weight of its overbearing public sector. Now the “liberal democracies” are threatened—socially, politically, even economically—by the unchecked excesses of the private sector. Radical renewal will have to begin in the plural sector, which alone has the inclination and the independence to challenge unacceptable practices and develop better ones. Too many governments have been co-opted by the private sector. And corporate social responsibility can't compensate for the corporate social irresponsibility we see around us “They” won't do it. We shall have to do it, each of us and all of us, not as passive “human resources,” but as resourceful human beings. Tom Paine wrote in 1776, “We have it in our power to begin the world over again.” He was right then. Can we be right again now? Can we afford not to be?
Author: Henry Mintzberg
Publisher: Berrett-Koehler Publishers
ISBN: 1523098791
Category : Business & Economics
Languages : en
Pages : 201
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Book Description
If you're like most managers and things keep you up at night, now you can turn to a book that's designed especially for you! But you won't find talking rabbits or princesses here. (There is a cow, but it doesn't jump.) Henry Mintzberg has culled forty-two of the best posts from his widely read blog and turned them into a deceptively light, sneakily serious compendium of sometimes heretical reflections on management. The moral here is this: managers need to leave their castles and find out what's actually going on in their kingdoms. And like real bedtime stories, these essays have metaphors galore. So prepare to grow strategies like weeds and organize like a cow. Discover the maestro myth of managing, find the soft underbelly of hard data, and learn why downsizing is bloodletting and your board should be a bee. Mintzberg writes, “Just try not to be outraged by anything you read, because some of my most outrageous ideas turn out to be my best. They just take a while to become obvious.”
Author: Claude Combes
Publisher: University of Chicago Press
ISBN: 022677872X
Category : Science
Languages : en
Pages : 298
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Book Description
Parasites are a masterful work of evolutionary art. The tiny mite Histiostoma laboratorium, a parasite of Drosophila, launches itself, in an incredible display of evolutionary engineering, like a surface-to-air missile at a fruit fly far above its head. Gravid mussels such as Lampsilis ventricosa undulate excitedly as they release their parasitic larval offspring, conning greedy predators in search of a tasty meal into hosting the parasite. The Art of Being a Parasite is an extensive collection of these and other wonderful and weird stories that illuminate the ecology and evolution of interactions between species. Claude Combes illustrates what it means to be a parasite by considering every stage of its interactions, from invading to reproducing and leaving the host. An accessible and engaging follow-up to Combes's Parasitism, this book will be of interest to both scholars and nonspecialists in the fields of biodiversity, natural history, ecology, public health, and evolution.
Author: Daniel A. Wagner
Publisher: United Nations Education, Scientific & Cultural Organization
ISBN:
Category : Education
Languages : en
Pages : 196
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Book Description
The effective use of educational assessments is fundamental to improving learning. However, effective use does not refer only to the technical parameters or statistical methodologies. Learning assessments in use todaywhether large-scale or household surveys or hybrid (smaller, quicker, cheaper or SQC)have varied uses and purposes. The present volume provides a review of learning assessments, their status in terms of the empirical knowledge base, and some new ideas for improving their effectiveness, particularly for those children most in need. It is argued here that SQC learning assessments have the potential to enhance educational accountability, increase transparency, and support a greater engagement of stakeholders with an interest in improving learning. In addition, countries need a sustained policy to guide assessment choices, including a focus on poor and marginalized populations.
Author: Wangari Maathai
Publisher: Anchor
ISBN: 0307378098
Category : Political Science
Languages : en
Pages : 337
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Book Description
In this groundbreaking work, the Nobel Peace Prize-winner and founder of the Green Belt Movement offers a new perspective on the troubles facing Africa today. Too often these challenges are portrayed by the media in extreme terms connoting poverty, dependence, and desperation. Wangari Maathai, the author of Unbowed, sees things differently, and here she argues for a moral revolution among Africans themselves. Illuminating the complex and dynamic nature of the continent, Maathai offers “hardheaded hope” and “realistic options” for change and improvement. She deftly describes what Africans can and need to do for themselves, stressing all the while responsibility and accountability. Impassioned and empathetic, The Challenge for Africa is a book of immense importance.
Author: Itzhak Benenson
Publisher: John Wiley & Sons
ISBN: 9780470843499
Category : Science
Languages : en
Pages : 320
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Book Description
Geosimulation is hailed as ‘the next big thing’ in geographic modelling for urban studies. This book presents readers with an overview of this new and innovative field by introducing the spatial modelling environment and describing the latest research and development using cellular automata and multi-agent systems. Extensive case studies and working code is available from an associated website which demonstrate the technicalities of geosimulation, and provide readers with the tools to carry out their own modelling and testing. The first book to treat urban geosimulation explicitly, integrating socio-economic and environmental modelling approaches Provides the reader with a sound theoretical base in the science of geosimulation as well as applied material on the construction of geosimulation models Cross-references to an author-maintained associated website with downloadable working code for readers to apply the models presented in the book Visit the Author's Website for further information on Geosimulation, Geographic Automata Systems and Geographic Automata Software http://www.geosimulationbook.com
Author: Philip A. Pizzo
Publisher: Lippincott Williams & Wilkins
ISBN: 9780683303995
Category : Medical
Languages : en
Pages : 849
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Book Description
Recommended in the Brandon/Hill selected list of print books and journals for the small medical library - April 2001 & 2003 The Third Edition of this very popular book offers the most authoritative and comprehensive review of the impact of the HIV disease in infants, children, and adolescents.
