Download or read book Mise en application d outils de gestion du risque qualit au sein d un groupe international tel que Novo Nordisk written by Cécile Vallerie and published by . This book was released on 2019 with total page 79 pages. Available in PDF, EPUB and Kindle. Book excerpt: L'industrie pharmaceutique est encadrée par une réglementation stricte, exigeant la mise en place d'un système qualité robuste, afin de pouvoir garantir que les médicaments fabriqués sont conformes aux spécifications attendues. Cependant, au cours de leur cycle de vie, et notamment au cours de leur production, les médicaments sont sujets à des risques divers pouvant affecter leur qualité, leur efficacité et donc la sécurité des patients. C'est pourquoi, les autorités compétentes exigent que le management du risque qualité soit pleinement intégré au sein du système qualité de l'entreprisen, dans le bus de contribuer à la maitrise des processus de production. A travers cette présente thèse nous allons voir comment l'utilisation d'outils de management du risque peut contribuer à la maitrise de toutes les étapes de fabrication d'un médicament. De plus, nous allons voir comment la gestion du risque qualité peut être utilisée comme un véritable outil d'amélioration continue et de performance des procédés de production au sein de Novo Nordisk.
Download or read book Les excipiens au sein d un groupe pharmaceutique international written by Sybille de La Motte and published by . This book was released on 2023 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Les excipients pharmaceutiques ont un rôle essentiel dans la composition des médicaments. Si avant mars 2015 aucune réglementation n'imposait une gestion formalisée des excipients, depuis l'arrivée de la directive européenne 2015/C95/02, les autorités européennes imposent aux industries pharmaceutiques de renforcer leur maîtrise de la chaîne d'approvisionnement des excipients. Les industries pharmaceutiques sont dans l'obligation de déployer une démarche de sécurisation de la qualité des excipients à travers le management du risque. L'objectif est de classer chaque excipient ainsi que son fabricant en fonction d'un niveau de risque. L'application des référentiels existants et la réponse des fabricants aux différentes sollicitations des laboratoires pharmaceutiques, dont les audits, dépendent uniquement du bon vouloir des fabricants d'excipients. De ce fait, la mise en place d'une collaboration avec ces derniers est essentielle afin de leur faire accepter les guides normatifs tel que celui proposé par l'IPEC. La mise en place d'une stratégie de gestion et d'évaluation des fabricants d'excipients, en uniformisant les pratiques d'un groupe, permettent de concentrer les efforts et les ressources qualifiées là où les risques sont les plus élevés. L'utilisation d'outils transversaux permet également la coordination et la mutualisation des audits au sein d'un groupe. L'objectif de l'assurance de la qualité des produits pharmaceutiques est à la fois de garantir non seulement la qualité des médicaments mais également celle de toutes les activités pharmaceutiques visant à produire une spécialité qui allie la qualité, la sécurité et l'efficacité
Download or read book Les grands principes du Risk Management written by Catherine Véret Jost and published by L'Argus de l'assurance. This book was released on 2019-10-09 with total page 765 pages. Available in PDF, EPUB and Kindle. Book excerpt: L'objectif de cet ouvrage est de proposer un Guide pratique du risk management au 21è siècle. Traité opérationnel et pédagogique (définition et portée pratique des différentes notions) à destination des professionnels de l'assurance et leurs partenaires et assurés (entreprises, collectivités, associations), l'ouvrage sera bilingue français-anglais afin de toucher un public le plus large possible sur une thématique par nature internationale. Il permet ainsi d'avoir un comparatif entre le droit français et le droit européen.
Download or read book Heritage Sites of Astronomy and Archaeoastronomy in the Context of the UNESCO World Heritage Convention written by Clive L. N. Ruggles and published by Ocarina Books. This book was released on 2012 with total page 298 pages. Available in PDF, EPUB and Kindle. Book excerpt: This Thematic Study is a joint venture between ICOMOS, the advisory body to UNESCO on cultural sites, and the International Astronomical Union. It presents an overall vision on astronomical heritage, attempts to identify what constitutes "outstanding universal significance to humankind" in relation to astronomy, and identifies broad issues that could arise in the assessment of cultural properties relating to astronomy. This is the first Thematic Study in any field of science heritage. It is elaborated using examples of properties from around the world, including some already on the World Heritage List or national Tentative Lists. The subject matter ranges from early prehistory to modern astrophysics and space heritage, and also prominently includes dark sky issues and modern observatory sites. An e-version of the Thematic Study was published in June 2010 in time to be presented to the 2010 meeting of UNESCO's World Heritage Committee, where it was duly approved. It has been circulated officially by the WHC to all of UNESCO's National Commissions. This full-colour paperback edition with some updates, and reformatted to new ICOMOS standards, was published in 2011 and is now offered for public sale.
Download or read book Verdensarv i Norden 2004 written by and published by Nordic Council of Ministers. This book was released on 2005 with total page 106 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book World Heritage Cultural Landscapes 1992 2002 written by P. J. Fowler and published by . This book was released on 2003 with total page 140 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Safety Assessment of Transgenic Organisms written by OECD. and published by . This book was released on 2011 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Connecting Histories of Education written by Barnita Bagchi and published by Berghahn Books. This book was released on 2014-03-01 with total page 261 pages. Available in PDF, EPUB and Kindle. Book excerpt: The history of education in the modern world is a history of transnational and cross-cultural influence. This collection explores those influences in (post) colonial and indigenous education across different geographical contexts. The authors emphasize how local actors constructed their own adaptation of colonialism, identity, and autonomy, creating a multi-centric and entangled history of modern education. In both formal as well as informal aspects, they demonstrate that transnational and cross-cultural exchanges in education have been characterized by appropriation, re-contextualization, and hybridization, thereby rejecting traditional notions of colonial education as an export of pre-existing metropolitan educational systems.
Download or read book International Human Rights Law in Africa written by Frans Viljoen and published by OUP Oxford. This book was released on 2012-03-29 with total page 661 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides a comprehensive and analytical overview of human rights law in Africa. It examines the institutions, norms, and processes for human rights realization provided for under the United Nations system, the African Union, and sub-regional economic communitites in Africa, and explores their relationship with the national legal systems of African states. Since the establishment of the African Union in 2001, there has been a proliferation of regional institutions that are relevant to human rights in Africa. These include the Pan African Parliament, the Peace and Security Council, the Economic, Social and Cultural Council and the African Peer Review Mechanism of the New Partnership for Africa's Development. This book discusses the links between these institutions. It further examines the case law stemming from Africa' most important human rights instrument, the African Charter on Human and Peoples Rights, which entered into force on 21 October 1986. This new edition contains a new chapter on the African Children's Rights Committee as well as full coverage of new developments and instruments, such as the Convention on the Rights of Persons with Disabilities, the Convention on Enforced Disappearances, and the African Charter on Democracy, Elections and Governance. Three cross-cutting themes are explored throughout the book: national implementation and enforcement of international human rights law; legal and other forms of integration; and the role of human rights in the eradication of poverty. The book also provides an introduction to the relevant human rights concepts.
Download or read book Cultural Landscapes of Universal Value written by Bernd von Droste and published by . This book was released on 1995 with total page 472 pages. Available in PDF, EPUB and Kindle. Book excerpt: Cultural landscapes are at the interface between nature and culture. They represent the permanent interaction between humans and their environment, shaping the surface of the earth. With the rapid social and economic development cultural landscapes belong to the most fragile and threatened sites on earth. Adapted protection and proper management is urgently needed. Since 1992 outstanding cultural landscapes can be protected under the World Heritage Convention. Thus, the World Heritage Convention is the first international legal instrument recognizing and safeguarding this type of property for future generations. This important step has led to enhanced international and national recognition. The present volume aims to contribute to enhanced protection and management of cultural landscapes around the world. It furthermore highlights in a truly interdisciplinary approach some of the most outstanding cultural landscapes of universal value in their geocultural and environmental context.
Download or read book Harmonisation of Regulatory Oversight in Biotechnology Safety Assessment of Transgenic Organisms Volume 4 OECD Consensus Documents written by OECD and published by OECD Publishing. This book was released on 2010-11-09 with total page 339 pages. Available in PDF, EPUB and Kindle. Book excerpt: These OECD Biosafety Consensus Documents identify elements of scientific information used in the environmental safety and risk assessment of transgenic organisms which are common to OECD member countries and some non members associated with the work.
Download or read book The sustainable enterprise learning from DJSI leaders written by and published by Fundacion BBVA. This book was released on 2005 with total page 260 pages. Available in PDF, EPUB and Kindle. Book excerpt: En los últimos años, las expresiones sostenibilidad, desarrollo sostenible, responsabilidad corporativa y empresa sostenible se han incorporado al vocabulario habitual de directivos, empresarios y académicos. Sin embargo, todavía subsisten cierta confusión y diferentes opiniones sobre el significado e implicaciones de dichos conceptos. El objetivo básico de este libro ha sido arrojar luz sobre la noción de empresa sostenible, abordando cuestiones como qué es una empresa sostenible, cuáles son sus principales características o en qué difiere del modelo de empresa tradicional. Para realizar este estudio se ha elegido a los dieciocho líderes sectoriales del Índice Dow Jones de Sostenibilidad (IDJS). Uno de los conceptos básicos en que se basa La empresa sostenible se refiere a los valores que una empresa ha de interiorizar para avanzar hacia la sostenibilidad. El valor central de la empresa sostenible es su conciencia del sistema del que forma parte y su sentido de pertenencia al mismo. En lugar de ser una depredadora neta del sistema físico-social, la empresa sostenible obtiene recursos del sistema con el propósito de contribuir a la creación neta de riqueza. De acuerdo con esta concepción, y a través del análisis de las dieciocho empresas líderes del IDJS, se explora cómo estas empresas están integrando la sostenibilidad en su gobierno, en la formulación de su estrategia y en sus sistemas de gestión. Asimismo, se analiza de qué manera su apertura hacia el entorno físico y social ha contribuido al desarrollo de un diálogo honesto, fluido y abierto con grupos de partes interesadas. Los resultados, conclusiones y buenas prácticas descritos en este libro resultarán útiles a aquellas compañías que, conscientes de la importancia de la sostenibilidad, están intentando interiorizar el desarrollo sostenible como un motor fundamental de sus procesos de creación de valor. Asimismo, la conceptualización de la empresa sostenible podrá servir de base para futuros proyectos de investigación.
Download or read book Coastal Tourism written by and published by . This book was released on 1997 with total page 200 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book The International Tribunal for the Law of the Sea written by Gudmundur Eiriksson and published by BRILL. This book was released on 2021-07-26 with total page 419 pages. Available in PDF, EPUB and Kindle. Book excerpt: This work examines the constitution, jurisdiction and procedure of the International Tribunal for the Law of the Sea on the basis of its Statute and Rules, as well as the Resolution on the Internal Judicial Practice and the Guidelines concerning the Preparation and Presentation of Cases. It gives a critical analysis of the role of the Tribunal in the settlement of law of the sea disputes. The articles were previously published in the Indian Journal of International Law and are revised, edited and updated for this edition. The contributors are sitting judges of the Tribunal and the book thus gives a perfect insider's view of the law and practice of the Tribunal.
Download or read book The Translation of Films 1900 1950 written by Carol O'Sullivan and published by Proceedings of the British Aca. This book was released on 2019 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: This rich collection of articles and essays by film historians, translation scholars, archivists, and curators presents film translation history as an exciting and timely area of research. It builds on the last twenty years of research into the history of dubbing and subtitling, but goes further, by showing how subtitling, dubbing, and other forms of audiovisual translation developed over the first fifty years of the twentieth century. This is the first book-length study, in any language, of the international history of audiovisual translation which includes silent cinema. Its scope covers national contexts both within Europe and beyond. It shows how audiovisual translation practices were closely tied to their commercial, technological and industrial contexts. The Translation of Films, 1900-1950 draws extensively on archival sources and expertise. In doing so it revisits and challenges some of the established narratives around film languages and the coming of sound. For instance, the volume shows how silent films, far from being straightforward to translate, went through a complex process of editing for international distribution. It also closely tracks the ferment of experiments in film translation during the transition to sound from 1927 to 1934 and later, as markets adjusted to the demands of synchronised film. The Translation of Films, 1900-1950 argues for a broader understanding of film translation: far from being limited to language transfer, it encompasses editing, localisation, censorship, paratextual framing, and other factors. It advocates for film translation to be considered as a crucial contribution not only to the worldwide circulation of films, but also to the art of cinema.
Download or read book Cinema All the Time written by Jaroslav Anděl and published by . This book was released on 2008 with total page 320 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Disability Law and Policy written by Charles O'Mahony (Lecturer in law) and published by . This book was released on 2017 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: "This book evolved from an event entitled 'Global PhD and Researchers Colloquium on Disability Law & Policy' organised by the Centre for Disability Law and Policy in NUI Galway in April 2010"--Introduction.
