Management De La Qualite Et Analyse Des Risques Amdec Dans Une Industrie Pharmaceutique

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Quality Management Audits in Nuclear Medicine Practices

Author : International Atomic Energy Agency
Publisher :
ISBN 13 : 9789201017154
Total Pages : 92 pages
Book Rating : 4.0/5 (171 download)

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Book Synopsis Quality Management Audits in Nuclear Medicine Practices by : International Atomic Energy Agency

Download or read book Quality Management Audits in Nuclear Medicine Practices written by International Atomic Energy Agency and published by . This book was released on 2015-10-08 with total page 92 pages. Available in PDF, EPUB and Kindle. Book excerpt: Quality management systems are essential and should be maintained with the intent to continuously improve effectiveness and efficiency, enabling nuclear medicine to achieve the expectations of its quality policy, satisfy its customers and improve professionalism. The quality management (QM) audit methodology in nuclear medicine practice, introduced in this publication, is designed to be applied to a variety of economic circumstances. A key outcome is a culture of reviewing all processes of the clinical service for continuous improvement in nuclear medicine practice. Regular quality audits and assessments are vital for modern nuclear medicine services. More importantly, the entire QM and audit process has to be systematic, patient oriented and outcome based. The management of services should also take into account the diversity of nuclear medicine services around the world and multidisciplinary contributions. The latter include clinical, technical, radiopharmaceutical, medical physics and radiation safety procedures.

Biomimicry

Author : Janine M. Benyus
Publisher : Harper Collins
ISBN 13 : 0061958921
Total Pages : 324 pages
Book Rating : 4.0/5 (619 download)

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Book Synopsis Biomimicry by : Janine M. Benyus

Download or read book Biomimicry written by Janine M. Benyus and published by Harper Collins. This book was released on 2009-08-11 with total page 324 pages. Available in PDF, EPUB and Kindle. Book excerpt: Repackaged with a new afterword, this "valuable and entertaining" (New York Times Book Review) book explores how scientists are adapting nature's best ideas to solve tough 21st century problems. Biomimicry is rapidly transforming life on earth. Biomimics study nature's most successful ideas over the past 3.5 million years, and adapt them for human use. The results are revolutionizing how materials are invented and how we compute, heal ourselves, repair the environment, and feed the world. Janine Benyus takes readers into the lab and in the field with maverick thinkers as they: discover miracle drugs by watching what chimps eat when they're sick; learn how to create by watching spiders weave fibers; harness energy by examining how a leaf converts sunlight into fuel in trillionths of a second; and many more examples. Composed of stories of vision and invention, personalities and pipe dreams, Biomimicry is must reading for anyone interested in the shape of our future.

New Drugs in Oncology

Author : W. Queisser
Publisher : S. Karger AG (Switzerland)
ISBN 13 :
Total Pages : 320 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis New Drugs in Oncology by : W. Queisser

Download or read book New Drugs in Oncology written by W. Queisser and published by S. Karger AG (Switzerland). This book was released on 1989 with total page 320 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Capillary Electrophoresis - Mass Spectrometry (CE-MS)

Author : Gerhardus de Jong
Publisher : John Wiley & Sons
ISBN 13 : 3527339248
Total Pages : 364 pages
Book Rating : 4.5/5 (273 download)

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Book Synopsis Capillary Electrophoresis - Mass Spectrometry (CE-MS) by : Gerhardus de Jong

Download or read book Capillary Electrophoresis - Mass Spectrometry (CE-MS) written by Gerhardus de Jong and published by John Wiley & Sons. This book was released on 2016-09-13 with total page 364 pages. Available in PDF, EPUB and Kindle. Book excerpt: Diese Monographie bietet einen vollständigen Überblick über die Prinzipien und Anwendungen der Kapillarelektrophorese (CE) und der Massenspektrometrie (MS) und legt den Nachdruck insbesondere auf Kopplungsschnittstellen. Ausführlich erläutert werden auch alle relevanten Substanzklassen. Ein einzigartiges Wissenskompendium für alle, die sich CE-MS beschäftigen!

Handbook of Clinical Nanomedicine

Author : Raj Bawa
Publisher : Pan Stanford
ISBN 13 : 9789814669221
Total Pages : 0 pages
Book Rating : 4.6/5 (692 download)

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Book Synopsis Handbook of Clinical Nanomedicine by : Raj Bawa

Download or read book Handbook of Clinical Nanomedicine written by Raj Bawa and published by Pan Stanford. This book was released on 2015-07-31 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: The exciting advances in nanomedicine in the past two decades highlight the growing need for an authoritative and comprehensive reference that can be relied upon by scientists, clinicians, academics, industry, students, lawyers, and policy-makers alike. With this in mind, the Handbook of Clinical Nanomedicine: Law, Business, Regulation, Safety, and Risk and its related companion volumes in the series aim to provide a broad survey of interconnected topics pertaining to clinical nanomedicine. This is the second volume in the series. Each volume is intended to be a stand‐alone reference source, presented in a user-friendly format for easy access. This volume examines nanomedical products’ entire "product life cycle" from the creation of nanomedical products to the final market introduction. It not only provides a comprehensive roadmap of basic and clinical research but also tackles critical topics such as regulatory science, intellectual property law, risk analysis, toxicology, nano-characterization, and commercialization activities. All chapters contain keywords, figures in full color, author biographies, and an extensive list of references. The handbook is truly essential reading for the novice and the expert alike in fields such as medicine, law, biotechnology, pharmaceutical sciences, engineering, policy, future studies, ethics, licensing, and toxicology, among others. While bridging the gap between basic biomedical research, engineering, medicine, law, and commercialization, the handbook allows readers to gain a thorough understanding of nano’s potential to address medical problems from both the patient and the health provider’s point of view; current applications and potential in a healthcare setting; regulatory, environment, and health issues; and intellectual property, licensing, and commercialization issues as well as business considerations. The editor and assistant editors have skillfully curated each chapter to reflect the most relevant and current information possible. The range of topics covered as well as the diverse selection of distinguished authors is truly impressive. The multidisciplinary approach of this handbook as well as its focus on not only scientific and technical aspects of nanomedicine but also legal, regulatory, policy, and commercial aspects will attract a global audience. In short, the Handbook of Clinical Nanomedicine: Law, Business, Regulation, Safety, and Risk promises to be a standard reference for any serious practitioner in this expansive field.

Sports Endocrinology

Author : F. Lanfranco
Publisher : Karger Medical and Scientific Publishers
ISBN 13 : 3318058696
Total Pages : 182 pages
Book Rating : 4.3/5 (18 download)

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Book Synopsis Sports Endocrinology by : F. Lanfranco

Download or read book Sports Endocrinology written by F. Lanfranco and published by Karger Medical and Scientific Publishers. This book was released on 2016-06-28 with total page 182 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is an up-to-date, extensive overview of the effects of physical activity and training on endocrine function. It gives insights into a complex relationship by describing effects with respect to exercise performance, growth, development, and ageing. It includes discussions of the endocrine response depending on exercise mode, intensity, and duration as well as on gender, age, and fitness level. Additionally the book deals with the impact of environmental and psychological factors on endocrine level. A substantial part of Sports Endocrinology is devoted to the 'hot topic' of hormonal doping in sports. The properties of androgens, growth hormone, erythropoietin, and dietary supplements are highlighted. The use and abuse among professional and recreational athletes is discussed and specific methods of detection are presented and explained. All contributors are well-known experts in sports medicine and endocrinology, endocrine physiology, pharmacology, and doping detection, so this book is a must-read for every professional involved in the field.

Capillary Electrophoresis of Proteins and Peptides

Author : Nguyet Thuy Tran
Publisher : Humana
ISBN 13 : 9781493940127
Total Pages : 0 pages
Book Rating : 4.9/5 (41 download)

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Book Synopsis Capillary Electrophoresis of Proteins and Peptides by : Nguyet Thuy Tran

Download or read book Capillary Electrophoresis of Proteins and Peptides written by Nguyet Thuy Tran and published by Humana. This book was released on 2016-07-30 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides a comprehensive survey of recent developments and applications of high performance capillary electrophoresis in the field of protein and peptide analysis with a distinct focus on the analysis of intact proteins. With practical detail, the contents cover different modes of capillary electrophoresis (CE) useful for protein and peptide analysis, CZE, CIEF, ACE, CGE, and different types of application such as the quality control of therapeutic proteins and monoclonal antibodies, clinical analyses of chemokines in tissues, qualitative and quantitative analysis of vaccine proteins, and determination of binding constants in complexes involving peptides or proteins. Written for the highly successful Methods in Molecular Biology series, chapters include introductions to their respective topics, lists of the necessary materials and reagents, step-by-step, readily reproducible laboratory protocols, and tips on troubleshooting and avoiding known pitfalls. Authoritative and exhaustive, Capillary Electrophoresis of Proteins and Peptides: Methods and Protocols serves both beginners and experts with a collection of the current and most active topics in this vital field of study.

Quality Risk Management in the FDA-Regulated Industry

Author : José Rodríguez-Pérez
Publisher : Quality Press
ISBN 13 : 1953079326
Total Pages : 252 pages
Book Rating : 4.9/5 (53 download)

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Book Synopsis Quality Risk Management in the FDA-Regulated Industry by : José Rodríguez-Pérez

Download or read book Quality Risk Management in the FDA-Regulated Industry written by José Rodríguez-Pérez and published by Quality Press. This book was released on 2017-02-21 with total page 252 pages. Available in PDF, EPUB and Kindle. Book excerpt: The purpose of this new edition is to offer an updated view of the risk management field as it applies to medical products. Since the publication of the first edition (2012), the emphasis on risk-based processes has growth exponentially across all sectors, and risk management is now considered as significant as quality management. ISO 9001 was revised and now requires that top management promote the use of risk-based thinking. ISO 13485:2016, which specifies the requirements for a quality management system specific to the medical devices industry, also now shows a greater emphasis on risk management and risk-based decision making. In addition, the FDA Food Safety Modernization Act (FSMA) is the most important reform of U.S. food safety laws in more than 70 years. This indispensable book presents a systematic and comprehensive approach to quality risk management. It will assist medical and food product manufacturers with the integration of a risk management system or risk management principles and activities into their existing quality management system by providing practical explanations and examples. The appropriate use of quality risk management can facilitate compliance with regulatory requirements such as good manufacturing practice or good laboratory practice. All chapters have been updated and revised, and a new chapter has been added to discuss some of the most common pitfalls and misunderstandings regarding risk management, specifically those related to the use of FMEA as the only element of risk management programs. One of the appendices includes 12 case studies, and the companion CD-ROM contains dozens of U.S. FDA and European guidance documents as well as international harmonization documents (ICH and GHTF-IMDRF) related to risk management activities, as well as a 30-question exam (with answers) on the material discussed in the book.

Trends in Vital Food and Control Engineering

Author : Ayman Hafiz Amer Eissa
Publisher :
ISBN 13 : 9789535152682
Total Pages : 304 pages
Book Rating : 4.1/5 (526 download)

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Book Synopsis Trends in Vital Food and Control Engineering by : Ayman Hafiz Amer Eissa

Download or read book Trends in Vital Food and Control Engineering written by Ayman Hafiz Amer Eissa and published by . This book was released on 2012 with total page 304 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is an example of a successful addition to the literature of bioengineering and processing control within the scientific world. The book is divided into twelve chapters covering: selected topics in food engineering, advances in food process engineering, food irradiation, food safety and quality, machine vision, control systems and economics processing. All chapters have been written by renowned professionals working in food engineering and related disciplines.

Quality Risk Management in the FDA-Regulated Industry

Author : Jose (Pepe) Rodriguez-Perez
Publisher : Quality Press
ISBN 13 : 1636941567
Total Pages : 313 pages
Book Rating : 4.6/5 (369 download)

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Book Synopsis Quality Risk Management in the FDA-Regulated Industry by : Jose (Pepe) Rodriguez-Perez

Download or read book Quality Risk Management in the FDA-Regulated Industry written by Jose (Pepe) Rodriguez-Perez and published by Quality Press. This book was released on 2024-04-18 with total page 313 pages. Available in PDF, EPUB and Kindle. Book excerpt: For quality professionals and manufacturers in the food safety and medical device industries, risk management is essential to ensuring organizations meet FDA regulations and requirements. Without these recognized standards, the lives of patients and consumers are placed in jeopardy. In this third edition of Quality Risk Management in the FDA-Regulated Industry, Jose Rodriguez-Perez provides an updated view of the risk management field as it applies to FDA-regulated products using risk-based thinking.

Food Safety

Author : Steven Ricke
Publisher : Academic Press
ISBN 13 : 0128004045
Total Pages : 466 pages
Book Rating : 4.1/5 (28 download)

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Book Synopsis Food Safety by : Steven Ricke

Download or read book Food Safety written by Steven Ricke and published by Academic Press. This book was released on 2015-07-08 with total page 466 pages. Available in PDF, EPUB and Kindle. Book excerpt: Food Safety: Emerging Issues, Technologies and Systems offers a systems approach to learning how to understand and address some of the major complex issues that have emerged in the food industry. The book is broad in coverage and provides a foundation for a practical understanding in food safety initiatives and safety rules, how to deal with whole-chain traceability issues, handling complex computer systems and data, foodborne pathogen detection, production and processing compliance issues, safety education, and more. Recent scientific industry developments are written by experts in the field and explained in a manner to improve awareness, education and communication of these issues. - Examines effective control measures and molecular techniques for understanding specific pathogens - Presents GFSI implementation concepts and issues to aid in implementation - Demonstrates how operation processes can achieve a specific level of microbial reduction in food - Offers tools for validating microbial data collected during processing to reduce or eliminate microorganisms in foods

Handbook of Clinical Nanomedicine

Author : Raj Bawa
Publisher : CRC Press
ISBN 13 : 9814669210
Total Pages : 1686 pages
Book Rating : 4.8/5 (146 download)

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Book Synopsis Handbook of Clinical Nanomedicine by : Raj Bawa

Download or read book Handbook of Clinical Nanomedicine written by Raj Bawa and published by CRC Press. This book was released on 2016-02-22 with total page 1686 pages. Available in PDF, EPUB and Kindle. Book excerpt: This handbook (55 chapters) provides a comprehensive roadmap of basic research in nanomedicine as well as clinical applications. However, unlike other texts in nanomedicine, it not only highlights current advances in diagnostics and therapeutics but also explores related issues like nomenclature, historical developments, regulatory aspects, nanosim

Advances in Food Traceability Techniques and Technologies

Author : Montserrat Espiñeira
Publisher : Woodhead Publishing
ISBN 13 : 0081003218
Total Pages : 404 pages
Book Rating : 4.0/5 (81 download)

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Book Synopsis Advances in Food Traceability Techniques and Technologies by : Montserrat Espiñeira

Download or read book Advances in Food Traceability Techniques and Technologies written by Montserrat Espiñeira and published by Woodhead Publishing. This book was released on 2016-06-18 with total page 404 pages. Available in PDF, EPUB and Kindle. Book excerpt: Advances in Food Traceability Techniques and Technologies: Improving Quality Throughout the Food Chain covers in detail a topic of great importance to both the food industry which is obliged to provide clear and accurate labeling of their products and the government and other organizations which are tasked with verification of claims of food quality and safety. The traceability of food products is becoming ever more important as globalization continues to increase the complexity of food chains. Coverage in the book includes the wide range of technologies and techniques which have been utilized in the tracing of food products. In addition, the ways in which the misuse of food traceability will affect the quality of food is also covered throughout. The first part of the book introduces the concept of traceability in the food industry, highlighting advantages of a robust traceability and the difficulties involved in implementing them. The second part looks at the technologies used to trace products, and the third section reviews the legal requirements for food traceability in the EU, the US, and the rest of the world. The final section contains a number of case studies which evaluate how food traceability has been successfully implemented in various foods focusing on the quality of the food. - Provides a wide ranging overview of all recent advances in food traceability techniques and technologies - Presents case studies covering when food traceability techniques have been applied to a range of food stuffs - Covers the legal aspects of food traceability in the EU, the USA, and around the world

Management des risques pour un développement durable

Author : Xavier Michel
Publisher : Dunod
ISBN 13 : 2100539191
Total Pages : 477 pages
Book Rating : 4.1/5 (5 download)

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Book Synopsis Management des risques pour un développement durable by : Xavier Michel

Download or read book Management des risques pour un développement durable written by Xavier Michel and published by Dunod. This book was released on 2009-02-25 with total page 477 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pour faire face à la pression sociale, économique et réglementaire, les entreprises s'orientent aujourd'hui vers un management global de la qualité, qui inclut les préoccupations de sécurité et d'environnement. Ces démarches suivent globalement le même processus (amélioration continue, PDCA) et conduisent chacune à la mise en place de manuels descriptifs, de procédures, de plans d'action et d'outils de traçabilité. Cet ouvrage est le premier à faire la synthèse des trois concepts, qualité, sécurité et environnement, en détaillant pour chacun les bases réglementaires et normatives, et en donnant les méthodes et les outils qui permettent leur mise en oeuvre dans l'entreprise.

Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing

Author : Hamid Mollah
Publisher : John Wiley & Sons
ISBN 13 : 1118514343
Total Pages : 432 pages
Book Rating : 4.1/5 (185 download)

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Book Synopsis Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing by : Hamid Mollah

Download or read book Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing written by Hamid Mollah and published by John Wiley & Sons. This book was released on 2013-02-01 with total page 432 pages. Available in PDF, EPUB and Kindle. Book excerpt: Sets forth tested and proven risk management practices in drug manufacturing Risk management is essential for safe and efficient pharmaceutical and biopharmaceutical manufacturing, control, and distribution. With this book as their guide, readers involved in all facets of drug manufacturing have a single, expertly written, and organized resource to guide them through all facets of risk management and analysis. It sets forth a solid foundation in risk management concepts and then explains how these concepts are applied to drug manufacturing. Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing features contributions from leading international experts in risk management and drug manufacturing. These contributions reflect the latest research, practices, and industry standards as well as the authors' firsthand experience. Readers can turn to the book for: Basic foundation of risk management principles, practices, and applications Tested and proven tools and methods for managing risk in pharmaceutical and biopharmaceutical product manufacturing processes Recent FDA guidelines, EU regulations, and international standards governing the application of risk management to drug manufacturing Case studies and detailed examples demonstrating the use and results of applying risk management principles to drug product manufacturing Bibliography and extensive references leading to the literature and helpful resources in the field With its unique focus on the application of risk management to biopharmaceutical and pharmaceutical manufacturing, this book is an essential resource for pharmaceutical and process engineers as well as safety and compliance professionals involved in drug manufacturing.

Qualité en production

Author : Daniel Duret
Publisher : Editions Eyrolles
ISBN 13 : 2212047533
Total Pages : 408 pages
Book Rating : 4.2/5 (12 download)

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Book Synopsis Qualité en production by : Daniel Duret

Download or read book Qualité en production written by Daniel Duret and published by Editions Eyrolles. This book was released on 2011-07-07 with total page 408 pages. Available in PDF, EPUB and Kindle. Book excerpt: Un ouvrage de référence et de synthèse Simple : les connaissances de base nécessaires à l'application des concepts qualité dans une entreprise de production Global : un panorama des différentes méthodes utilisées dans les entreprises Opérationnel : les outils indispensables à la mise en place d'un système qualité Concret et précis : de très nombreux exemples La qualité est une condition indispensable pour présenter un produit sur le marché. Pour obtenir cette qualité, l'entreprise doit structurer son organisation autour d'un modèle, souvent la norme ISO 9001. Mais elle doit également mettre en œuvre des méthodes et des outils pour accroître sa performance. Ce livre expose les connaissances de base nécessaires à l'application des concepts "qualité" dans une entreprise de production et donne une image globale des différentes méthodes actuellement utilisées dans les entreprises. La première partie de l'ouvrage est consacrée au système de management de la qualité fondée sur une démarche orientée client et sur la maîtrise des processus. Elle aborde notamment le modèle ISO 9001, "Systèmes de management de la qualité : Exigences", les référentiels de l'industrie automobile, la maîtrise des documents et l'automaîtrise au niveau du poste de travail. La seconde partie est axée sur les méthodes et les outils de la qualité : outils de résolution de problème, OFD, plans d'expériences, AMDEC, MSP, contrôle de réception, fonction métrologique (GRR, GUM) et l'approche "Six Sigma" qui permet d'obtenir l'amélioration par percée. Cet ouvrage s'adresse ainsi : aux professionnels, cadres et techniciens travaillant dans un contexte de production aux enseignants et étudiants pour la préparation des BTS, DUT, IUP des secteurs industriels et des écoles d'ingénieurs

La validation intégrée

Author : Daniel Mouton
Publisher : Dunod
ISBN 13 : 2100536222
Total Pages : 226 pages
Book Rating : 4.1/5 (5 download)

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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.