Optimisation et mise à jour de la documentation de fabrication d'un produit pour essais cliniques

Download Optimisation et mise à jour de la documentation de fabrication d'un produit pour essais cliniques PDF Online Free

Author :
Publisher :
ISBN 13 :
Total Pages : 92 pages
Book Rating : 4.:/5 (493 download)

DOWNLOAD NOW!


Book Synopsis Optimisation et mise à jour de la documentation de fabrication d'un produit pour essais cliniques by : Céline Duhamel

Download or read book Optimisation et mise à jour de la documentation de fabrication d'un produit pour essais cliniques written by Céline Duhamel and published by . This book was released on 2006 with total page 92 pages. Available in PDF, EPUB and Kindle. Book excerpt: L'IgNG est actuellement un produit dérivé du plasma humain en essais cliniques. Son process de fabrication évolue au cours de ses productions. La documentation qualité associée doit donc évoluer en même temps. Dans le système de l'Assurance Qualité, les documents, en particulier ceux de production, ont une place importante. En effet, ils assurent la reproductibilité et la traçabilité des lots produits. Ces documents doivent être le plus simple et le plus claire possible afin de faciliter leur utilisation et donc de limiter les erreurs en cours de production. L'optimisation et la mise à jour de ce type de document sont basées sur les documents existants, l'expérience du personnel (le terrain) et le guide de Bonnes Pratiques de Fabrication. Les documents revus ou créés ne resteront pas statiques. Leur évolution suit celle du process et celle de l'assurance qualité. En effet, les documents vivent en même temps que le produit fabriqué et entrent dans un procédé d'amélioration continue.

Optimisation de la traçabilité documentaire dans les activités de fabrication de lots cliniques

Download Optimisation de la traçabilité documentaire dans les activités de fabrication de lots cliniques PDF Online Free

Author :
Publisher :
ISBN 13 :
Total Pages : 0 pages
Book Rating : 4.:/5 (141 download)

DOWNLOAD NOW!


Book Synopsis Optimisation de la traçabilité documentaire dans les activités de fabrication de lots cliniques by : Oyediya Uchendu Ndukwe

Download or read book Optimisation de la traçabilité documentaire dans les activités de fabrication de lots cliniques written by Oyediya Uchendu Ndukwe and published by . This book was released on 2023 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Dans l'industrie pharmaceutique, la documentation est le pilier de l'entreprise, ce qui nécessite la mise en place d'un système documentaire efficace pour la gestion des documents qualité. Cette documentation est souvent confrontée à des problèmes de lourdeur et de complexité, rendant donc son utilisation difficile pour le personnel. Afin d'établir un système documentaire performant, l'entreprise doit fournir des moyens adaptés permettant de pérenniser et protéger son savoir-faire. L' objectif de cette thèse est d'optimiser et de simplifier le système documentaire ainsi que la gestion de la traçabilité documentaire dans les activités de fabrication de lots cliniques. La première partie de la thèse est axée sur la maîtrise du système documentaire. La deuxième partie présente les exigences réglementaires et l'analyse des écarts entre le système existant et les exigences règlementaire. La dernière partie est un exemple concret du projet d'amélioration continue en qualité. Ce projet a permis la mise en place d'un nouveau système de gestion des documents qualifiants et non qualifiants ainsi que la traçabilité documentaire dans les activités de fabrication de lots cliniques. Afin de faciliter l'utilisation du nouveau système documentaire, un guide a été créé. Cela a été possible grâce à l'une des méthodes de Lean Management qui est le PDCA et à la maîtrise des différents outils de management de la qualité.

Optimisation du dossier de lot

Download Optimisation du dossier de lot PDF Online Free

Author :
Publisher :
ISBN 13 :
Total Pages : 206 pages
Book Rating : 4.:/5 (8 download)

DOWNLOAD NOW!


Book Synopsis Optimisation du dossier de lot by : Pierre Corbeiller

Download or read book Optimisation du dossier de lot written by Pierre Corbeiller and published by . This book was released on 2011 with total page 206 pages. Available in PDF, EPUB and Kindle. Book excerpt: On considère le dossier de lot dans l'industrie pharmaceutique comme un élément majeur de leur système qualité. Il fait partie intégrante de ce système, c'est un outil réglementé qui assure la conformité et la qualité d'un lot de médicament. Il permet dans le cadre d'anomalie de réaliser des investigations et d'apporter des réponses grâce aux diverses informations contenues dans ce document. Le dossier de lot est constitué des différents documents d'enregistrement utilisés durant le processus de production du médicament : la fabrication, le conditionnement et également le contrôle. Le dossier de lot est un document permettant de retracer précisément l'historique d'un lot. Il fournit les informations nécessaires aux personnels afin qu'ils mènent à bien les étapes de production selon les différentes spécifications du produit tout en respectant les BPF en vigueur. Il témoigne de la bonne réalisation de toutes les étapes de fabrication d'un produit. Il permet également l'enregistrement des données venant de la production. Son amélioration est envisagée pour optimiser son utilisation, faciliter sa modification, perfectionner ses informations. Le dossier de lot est un document clé pour les services : Réglementaire, Production, Assurance Qualité, Contrôle Qualité. Il en découle donc un grand nombre d'exigences telles que son accessibilité, sa praticité, sa fonctionnalité. Sa modernisation s'inscrit dans une démarche d'amélioration de la qualité. En premier lieu dans cette thèse sont abordées les notions liées à la qualité, au dossier de lot et à la gestion du changement sous forme de partie bibliographique. La seconde partie expose la méthodologie utilisée pour harmoniser et optimiser ces dossiers dans un contexte de sous-traitance pharmaceutique.

Bonnes pratiques de fabrication des médicaments vétérinaires en recherche et développement

Download Bonnes pratiques de fabrication des médicaments vétérinaires en recherche et développement PDF Online Free

Author :
Publisher :
ISBN 13 :
Total Pages : 122 pages
Book Rating : 4.:/5 (493 download)

DOWNLOAD NOW!


Book Synopsis Bonnes pratiques de fabrication des médicaments vétérinaires en recherche et développement by : Charlotte Becker

Download or read book Bonnes pratiques de fabrication des médicaments vétérinaires en recherche et développement written by Charlotte Becker and published by . This book was released on 2005 with total page 122 pages. Available in PDF, EPUB and Kindle. Book excerpt: Afin d'assurer la qualité et la sécurité des médicaments fabriqués, l'entreprise doit se doter d'un système d'« assurance de qualité » performant, s'appuyant sur des textes réglementaires tels que « les Bonnes pratiques de fabrication » (BPF). Selon les BPF, un médicament de qualité ne peut être produit que dans des locaux adaptés, avec des équipements qualifiés et par un personnel formé, effectuant les tâches conformément à la documentation et aux instructions écrites. Cependant, certaines exigences des BPF doivent être adaptées dans le cas des médicaments vétérinaires et à plus forte raison lorsque ceux-ci sont destinés à des essais cliniques. Ce travail aborde donc les particularités des BPF appliquées aux médicaments vétérinaires et aux médicaments pour essais cliniques, ainsi que leur mise en œuvre concrète dans la zone de production d'un centre de recherche et développement. Dans ce cadre, la démarche de qualification d'un équipement utilisé dans la production de lots pour essais cliniques, est développée puis illustrée avec l'application à un lit d'air fluidisé.

Doing Business 2020

Download Doing Business 2020 PDF Online Free

Author :
Publisher : World Bank Publications
ISBN 13 : 1464814414
Total Pages : 241 pages
Book Rating : 4.4/5 (648 download)

DOWNLOAD NOW!


Book Synopsis Doing Business 2020 by : World Bank

Download or read book Doing Business 2020 written by World Bank and published by World Bank Publications. This book was released on 2019-11-21 with total page 241 pages. Available in PDF, EPUB and Kindle. Book excerpt: Seventeen in a series of annual reports comparing business regulation in 190 economies, Doing Business 2020 measures aspects of regulation affecting 10 areas of everyday business activity.

African Small Ruminant Research and Development

Download African Small Ruminant Research and Development PDF Online Free

Author :
Publisher : ILRI (aka ILCA and ILRAD)
ISBN 13 :
Total Pages : 598 pages
Book Rating : 4./5 ( download)

DOWNLOAD NOW!


Book Synopsis African Small Ruminant Research and Development by : R. T. Wilson

Download or read book African Small Ruminant Research and Development written by R. T. Wilson and published by ILRI (aka ILCA and ILRAD). This book was released on 1989-01-01 with total page 598 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume contains 44 papers and 2 abstracts from a international conference on African small ruminants research and development. eleven papers and 1 abstract deal with the importance of small ruminant production systems and economics. Another 11 describe and analyse feed resources and feeding systems and there are 6 papers on reproductive problems and their solutions. Seven papers and 1 abstract review the prevalent health problems under various management systems and present the solutions to these production constraints. The last 9 papers deal with breeds, breeding systems and breed improvement.

Global Burden of Disease and Risk Factors

Download Global Burden of Disease and Risk Factors PDF Online Free

Author :
Publisher : World Bank Publications
ISBN 13 : 0821362631
Total Pages : 511 pages
Book Rating : 4.8/5 (213 download)

DOWNLOAD NOW!


Book Synopsis Global Burden of Disease and Risk Factors by : Alan D. Lopez

Download or read book Global Burden of Disease and Risk Factors written by Alan D. Lopez and published by World Bank Publications. This book was released on 2006-04-02 with total page 511 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Innovate Bristol

Download Innovate Bristol PDF Online Free

Author :
Publisher :
ISBN 13 : 9781949677072
Total Pages : pages
Book Rating : 4.6/5 (77 download)

DOWNLOAD NOW!


Book Synopsis Innovate Bristol by : Sven Boermeester

Download or read book Innovate Bristol written by Sven Boermeester and published by . This book was released on 2019-12 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: Innovate Bristol highlights and celebrates those companies and individuals that are actively working at building a better tomorrow for all. Innovation Ecosystems thrive through the involvement and support of companies and individuals from all industries, which is why the Innovate series not only focuses on the innovators but also those people whom the Innovation Ecosystem, would not be able to thrive without.

Your Mindful Compass

Download Your Mindful Compass PDF Online Free

Author :
Publisher :
ISBN 13 : 9780615928791
Total Pages : 318 pages
Book Rating : 4.9/5 (287 download)

DOWNLOAD NOW!


Book Synopsis Your Mindful Compass by : Andrea Maloney Schara

Download or read book Your Mindful Compass written by Andrea Maloney Schara and published by . This book was released on 2013-12-01 with total page 318 pages. Available in PDF, EPUB and Kindle. Book excerpt: "Your Mindful Compass" takes us behind the emotional curtain to see the mechanisms regulating individuals in social systems. There is great comfort and wisdom in knowing we can increase our awareness to manage the swift and ancient mechanisms of social control. We can gain greater flexibility by seeing how social controls work in systems from ants to humans. To be less controlled by others, we learn how emotional systems influence our relationship-oriented brain. People want to know what goes on in families that give rise to amazing leaders and/or terrorists. For the first time in history we can understand the systems in which we live. The social sciences have been accumulating knowledge since the early fifties as to how we are regulated by others. S. Milgram, S. Ashe, P. Zimbardo and J. Calhoun, detail the vulnerability to being duped and deceived and the difficulty of cooperating when values differ. Murray Bowen, M.D., the first researcher to observe several live-in families, for up to three years, at the National Institute of Mental Health. Describing how family members overly influence one another and distribute stress unevenly, Bowen described both how symptoms and family leaders emerge in highly stressed families. Our brain is not organized to automatically perceive that each family has an emotional system, fine-tuned by evolution and "valuing" its survival as a whole, as much as the survival of any individual. It is easier to see this emotional system function in ants or mice but not in humans. The emotional system is organized to snooker us humans: encouraging us to take sides, run away from others, to pressure others, to get sick, to blame others, and to have great difficulty in seeing our part in problems. It is hard to see that we become anxious, stressed out and even that we are difficult to deal with. But "thinking systems" can open the doors of perception, allowing us to experience the world in a different way. This book offers both coaching ideas and stories from leaders as to strategies to break out from social control by de-triangling, using paradoxes, reversals and other types of interruptions of highly linked emotional processes. Time is needed to think clearly about the automatic nature of the two against one triangle. Time and experience is required as we learn strategies to put two people together and get self outside the control of the system. In addition, it takes time to clarify and define one's principles, to know what "I" will or will not do and to be able to take a stand with others with whom we are very involved. The good news is that systems' thinking is possible for anyone. It is always possible for an individual to understand feelings and to integrate them with their more rational brains. In so doing, an individual increases his or her ability to communicate despite misunderstandings or even rejection from important others. The effort involved in creating your Mindful Compass enables us to perceive the relationship system without experiencing it's threats. The four points on the Mindful Compass are: 1) Action for Self, 2) Resistance to Forward Progress, 3) Knowledge of Social Systems and the 4) The Ability to Stand Alone. Each gives us a view of the process one enters when making an effort to define a self and build an emotional backbone. It is not easy to find our way through the social jungle. The ability to know emotional systems well enough to take a position for self and to become more differentiated is part of the natural way humans cope with pressure. Now people can use available knowledge to build an emotional backbone, by thoughtfully altering their part in the relationship system. No one knows how far one can go by making an effort to be more of a self-defined individual in relationships to others. Through increasing emotional maturity, we can find greater individual freedom at the same time that we increase our ability to cooperate and to be close to others.

Markov Decision Processes with Applications to Finance

Download Markov Decision Processes with Applications to Finance PDF Online Free

Author :
Publisher : Springer Science & Business Media
ISBN 13 : 3642183247
Total Pages : 393 pages
Book Rating : 4.6/5 (421 download)

DOWNLOAD NOW!


Book Synopsis Markov Decision Processes with Applications to Finance by : Nicole Bäuerle

Download or read book Markov Decision Processes with Applications to Finance written by Nicole Bäuerle and published by Springer Science & Business Media. This book was released on 2011-06-06 with total page 393 pages. Available in PDF, EPUB and Kindle. Book excerpt: The theory of Markov decision processes focuses on controlled Markov chains in discrete time. The authors establish the theory for general state and action spaces and at the same time show its application by means of numerous examples, mostly taken from the fields of finance and operations research. By using a structural approach many technicalities (concerning measure theory) are avoided. They cover problems with finite and infinite horizons, as well as partially observable Markov decision processes, piecewise deterministic Markov decision processes and stopping problems. The book presents Markov decision processes in action and includes various state-of-the-art applications with a particular view towards finance. It is useful for upper-level undergraduates, Master's students and researchers in both applied probability and finance, and provides exercises (without solutions).

Pharmacopolitics

Download Pharmacopolitics PDF Online Free

Author :
Publisher : Chemical Heritage Foundation
ISBN 13 : 9780807828441
Total Pages : 232 pages
Book Rating : 4.8/5 (284 download)

DOWNLOAD NOW!


Book Synopsis Pharmacopolitics by : Arthur A. Daemmrich

Download or read book Pharmacopolitics written by Arthur A. Daemmrich and published by Chemical Heritage Foundation. This book was released on 2004 with total page 232 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmacopolitics: Drug Regulation in the United States and Germany

Comprehensive Cervical Cancer Control

Download Comprehensive Cervical Cancer Control PDF Online Free

Author :
Publisher : World Health Organization
ISBN 13 : 9241547006
Total Pages : 284 pages
Book Rating : 4.2/5 (415 download)

DOWNLOAD NOW!


Book Synopsis Comprehensive Cervical Cancer Control by : World Health Organization

Download or read book Comprehensive Cervical Cancer Control written by World Health Organization and published by World Health Organization. This book was released on 2006 with total page 284 pages. Available in PDF, EPUB and Kindle. Book excerpt: Most women who die from cervical cancer, particularly in developing countries, are in the prime of their life. They may be raising children, caring for their family, and contributing to the social and economic life of their town or village. Their death is both a personal tragedy, and a sad and unnecessary loss to their family and their community. Unnecessary, because there is compelling evidence, as this Guide makes clear, that cervical cancer is one of the most preventable and treatable forms of cancer, as long as it is detected early and managed effectively. Unfortunately, the majority of women in developing countries still do not have access to cervical cancer prevention programmes. The consequence is that, often, cervical cancer is not detected until it is too late to be cured. An urgent effort is required if this situation is to be corrected. This Guide is intended to help those responsible for providing services aimed at reducing the burden posed by cervical cancer for women, communities and health systems. It focuses on the knowledge and skills needed by health care providers, at different levels of care.

Emerging Trends in Computational Biology, Bioinformatics, and Systems Biology

Download Emerging Trends in Computational Biology, Bioinformatics, and Systems Biology PDF Online Free

Author :
Publisher : Morgan Kaufmann
ISBN 13 : 0128026464
Total Pages : 670 pages
Book Rating : 4.1/5 (28 download)

DOWNLOAD NOW!


Book Synopsis Emerging Trends in Computational Biology, Bioinformatics, and Systems Biology by : Hamid R Arabnia

Download or read book Emerging Trends in Computational Biology, Bioinformatics, and Systems Biology written by Hamid R Arabnia and published by Morgan Kaufmann. This book was released on 2015-08-11 with total page 670 pages. Available in PDF, EPUB and Kindle. Book excerpt: Emerging Trends in Computational Biology, Bioinformatics, and Systems Biology discusses the latest developments in all aspects of computational biology, bioinformatics, and systems biology and the application of data-analytics and algorithms, mathematical modeling, and simu- lation techniques. • Discusses the development and application of data-analytical and theoretical methods, mathematical modeling, and computational simulation techniques to the study of biological and behavioral systems, including applications in cancer research, computational intelligence and drug design, high-performance computing, and biology, as well as cloud and grid computing for the storage and access of big data sets. • Presents a systematic approach for storing, retrieving, organizing, and analyzing biological data using software tools with applications to general principles of DNA/RNA structure, bioinformatics and applications, genomes, protein structure, and modeling and classification, as well as microarray analysis. • Provides a systems biology perspective, including general guidelines and techniques for obtaining, integrating, and analyzing complex data sets from multiple experimental sources using computational tools and software. Topics covered include phenomics, genomics, epigenomics/epigenetics, metabolomics, cell cycle and checkpoint control, and systems biology and vaccination research. • Explains how to effectively harness the power of Big Data tools when data sets are so large and complex that it is difficult to process them using conventional database management systems or traditional data processing applications. Discusses the development and application of data-analytical and theoretical methods, mathematical modeling and computational simulation techniques to the study of biological and behavioral systems. Presents a systematic approach for storing, retrieving, organizing and analyzing biological data using software tools with applications. Provides a systems biology perspective including general guidelines and techniques for obtaining, integrating and analyzing complex data sets from multiple experimental sources using computational tools and software.

Biosocialities, Genetics and the Social Sciences

Download Biosocialities, Genetics and the Social Sciences PDF Online Free

Author :
Publisher : Routledge
ISBN 13 : 1134144725
Total Pages : 387 pages
Book Rating : 4.1/5 (341 download)

DOWNLOAD NOW!


Book Synopsis Biosocialities, Genetics and the Social Sciences by : Sahra Gibbon

Download or read book Biosocialities, Genetics and the Social Sciences written by Sahra Gibbon and published by Routledge. This book was released on 2007-07-20 with total page 387 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biosocialities, Genetics and the Social Sciences explores the social, cultural and economic transformations that result from innovations in genomic knowledge and technology. This pioneering collection uses Paul Rabinow’s concept of biosociality to chart the shifts in social relations and ideas about nature, biology and identity brought about by developments in biomedicine. Based on new empirical research, it contains chapters on genomic research into embryonic stem cell therapy, breast cancer, autism, Parkinson’s and IVF treatment, as well as on the expectations and education surrounding genomic research. It covers four main themes: novel modes of identity and identification, such as genetic citizenship the role of institutions, ranging from disease advocacy organizations and voluntary organizations to the state the production of biological knowledge, novel life-forms, and technologies the generation of wealth and commercial interests in biology. Including an afterword by Paul Rabinow and case studies on the UK, US, Canada, Germany, India and Israel, this book is key reading for students and researchers of the new genetics and the social sciences – particularly medical sociologists, medical anthropologists and those involved with science and technology studies.

Clinical Management of Patients with Viral Haemorrhagic Fever

Download Clinical Management of Patients with Viral Haemorrhagic Fever PDF Online Free

Author :
Publisher : World Health Organization
ISBN 13 : 9241549602
Total Pages : 203 pages
Book Rating : 4.2/5 (415 download)

DOWNLOAD NOW!


Book Synopsis Clinical Management of Patients with Viral Haemorrhagic Fever by : World Health Organization

Download or read book Clinical Management of Patients with Viral Haemorrhagic Fever written by World Health Organization and published by World Health Organization. This book was released on 2016-05-03 with total page 203 pages. Available in PDF, EPUB and Kindle. Book excerpt: First published in March 2014 under the title "Clinical management of patients with viral haemorrhagic fever: a pocket guide for front-line health workers: interim emergency guidance for West Africa".

The Complementarity of Feed Resources for Animal Production in Africa

Download The Complementarity of Feed Resources for Animal Production in Africa PDF Online Free

Author :
Publisher : ILRI (aka ILCA and ILRAD)
ISBN 13 : 9789290531999
Total Pages : 436 pages
Book Rating : 4.5/5 (319 download)

DOWNLOAD NOW!


Book Synopsis The Complementarity of Feed Resources for Animal Production in Africa by : John E. S. Stares

Download or read book The Complementarity of Feed Resources for Animal Production in Africa written by John E. S. Stares and published by ILRI (aka ILCA and ILRAD). This book was released on 1992-01-01 with total page 436 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Health System Performance Comparison: an Agenda for Policy, Information and Research

Download Health System Performance Comparison: an Agenda for Policy, Information and Research PDF Online Free

Author :
Publisher : McGraw-Hill Education (UK)
ISBN 13 : 033524727X
Total Pages : 418 pages
Book Rating : 4.3/5 (352 download)

DOWNLOAD NOW!


Book Synopsis Health System Performance Comparison: an Agenda for Policy, Information and Research by : Irene Papanicolas

Download or read book Health System Performance Comparison: an Agenda for Policy, Information and Research written by Irene Papanicolas and published by McGraw-Hill Education (UK). This book was released on 2013-06-16 with total page 418 pages. Available in PDF, EPUB and Kindle. Book excerpt: International comparison of health system performance has become increasingly popular, made possible by the rapidly expanding availability of health data. It has become one of the most important levers for prompting health system reform. Yet, as the demand for transparency and accountability in healthcare increases, so too does the need to compare data from different health systems both accurately and meaningfully. This timely and authoritative book offers an important summary of the current developments in health system performance comparison. It summarises the current state of efforts to compare systems, and identifies and explores the practical and conceptual challenges that occur. It discusses data and methodological challenges, as well as broader issues such as the interface between evidence and practice. The book draws out the priorities for future work on performance comparison, in the development of data sources and measurement instruments, analytic methodology, and assessment of evidence on performance. It concludes by presenting the key lessons and future priorities, and in doing so offers a rich source of material for policy-makers, their analytic advisors, international agencies, academics and students of health systems.