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Intro -- Title Page -- CIP Data Page -- Table of Contents -- List of Figures and Tables -- Acronyms -- Preface to the Second Edition -- Preface to the First Edition -- Acknowledgments -- Chapter 1: Introduction to Quality Risk Management -- 1.1 What Is Quality Risk Management? -- 1.2 Taste of Raspberries, Taste of Death: The 1937 Elixir Sulfanilamide Incident -- 1.3 Seventy Years Later -- 1.4 Risk Management and Risk Assessment -- 1.5 Risk-Based Approach -- FDA's Strategic Action Plan -- Risk-Based Model for Inspectional Oversight -- Part 11 Guidance -- Aseptic Processing Guidance -- 1.6 More than Safety Risks: From Safety Risks to Quality by Design (QBD) -- Medication Guides -- Quality by Design -- Design Controls for Medical Devices -- 1.7 ISO 31000 -- Scope -- 1.8 Historical Perspective and Current Situation -- 1.9 ISO 9001:2015 Risk Requirements -- Risk Management and Preventive Actions -- Chapter 2: Current Initiatives -- 2.1 FDA-Wide -- 2.2 Drugs and Biotechnology Products -- 2.2.1 ICH Q9 -- 2.2.2 QbD Guidances -- 2.2.3 REMS and Medication Guides -- 2.3 Medical Devices -- 2.3.1 ISO 13485:2016 Risk Requirements -- 2.3.2 ISO 14971:2007 -- 2.3.3 GHTF/IMDRF Guidelines -- 2.3.4 Non-U.S. Regulations -- 2.4 Food Safety -- 2.4.1 ISO 22000:2005 and Hazard Analysis and Critical Control Points (HACCP) -- 2.4.2 FDA Food Safety Modernization Act (FSMA): Risk-Based Food Safety Prevention -- 2.5 Supply Chain: Risk Consideration forRegulated Products -- Chapter 3: Principles of Quality Risk Management -- 3.1 Basic Principles -- Continual Improvement -- Full Accountability for Risks -- Application of Risk Managementin All Decision Making -- Continual Communications -- Full Integration into the Organization's Governance Structure -- 3.2 Science and Risk-Based Approach to Product Quality -- 3.3 Quality Systems Approach.

Cover -- Title page -- CIP data -- Table of Contents -- List of Figures and Tables -- Preface -- List of Acronyms -- Chapter 1-Introduction -- Facts About cGMP -- cGMP and the Quality System -- Notes -- Chapter 2-US Current Good Manufcturing Practice -- cGMP and The FDA -- Drugs Regulated by CDER -- Foreign Manufacturers -- Notes -- Chapter 3-International Good Manufacturing Practice -- The EU -- Canada -- Japan -- Brazil -- Australia -- China -- India -- Korea -- South Africa -- Russia -- New Zealand -- Notes -- Chapter 4-Global Good Manufacturing Practice Guides and Harmonization -- The WHO -- International Conference on Harmonization -- Pharmaceutical Inspection Convention and the Pharmaceutical Inspection Co-operation Scheme -- Notes -- Chapter 5-Details Analysis of the Requirements and Guidances -- Part 210-Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs: General -- Part 211-Current Good Manufacturing Practice for Finished Pharmaceuticals -- Notes -- Chapter 6-Missing Subparts -- Corrective and preventive action system -- Management Control -- Process Validations -- Notes -- Chapter 7-What Are Inspectors Looking For? -- Types of Inspections -- Drug Manufacturing Inspections -- Preapproval Inspection -- API Inspections -- Sterile Drug Process Inspection -- Notes -- Chapter 8-Quality at Risk: The Price of Noncompliance -- Field Alerts -- Recall Process for FDA-Regulated Products -- Form 483 -- Regulatory Meetings -- Dear Health Care Provider Letter -- Untitled and Warning Letters -- Criminal Investigations -- Seizure -- Injunctions -- Consent Decrees and Disgorgements -- Debarment and Disqualification List -- Progressive Enforcement -- Notes -- Appendix-At-a-Glance Comparisons -- Bibliography -- Useful Websites -- Index.

En este trabajo se analizan las conexiones entre la educación y los libros de texto escolares, identificando ambos conceptos y sus características, con especial interés en la asignatura de música. El objetivo fue comprender el tratamiento de dichos mediadores didácticos a lo largo de la historia del sistema educativo español, constatando la importancia otorgada y su concreción en la legislación educativa. La metodología utilizada fue cualitativa a través de una revisión documental. El corpus de la investigación fue el análisis de los preceptos legislativos educativos, valorando tanto la educación musical como los libros de texto, por medio de la clasificación. Se concluye presentando la dimensión del libro de texto de música como mediador didáctico, considerando las principales herramientas de análisis, para así facilitar con el proceso de su elección, establecer un marco de referencia y contribuir a la mejora educativa. This paper analyzes the connections between education and school textbooks, identifying both concepts and their characteristics, with special interest in the subject of music. The objective was to understand the treatment of such didactic mediators throughout the history of the Spanish educational system, noting the importance given and their concretion in the educational legislation. The methodology used was qualitative through a documentary review. The research´s corpus was the analysis of educational legislative, valuing music education and textbooks, through the classification. It concludes by presenting the dimension of music textbook as a teaching mediator, considering the main analysis tools, to facilitate the choice process, in order to establish a framework and contribute to educational improvement. Neste artigo, analisam-se as conexões entre a educação e os livros escolares, identificando os conceitos e suas características, com especial interesse no tema da música. O objetivo foi compreender o tratamento dos ditos mediadores didáticos ao longo da história do sistema educacional espanhol, confirmando a importância dada e sua concretização na legislação educacional. A metodologia utilizada foi qualitativa através de uma revisão documental. O corpus da pesquisa foi a análise de preceitos legislativos educacionais, valorizando tanto a formação musical quanto os livros didáticos, por meio da classificação. Conclui apresentando a dimensão do livro didático de música como mediador didático, considerando as principais ferramentas de análise, a fim de facilitar com o processo de sua escolha, estabelecer um quadro de referência e contribuir para a melhoria educacional.

AbstractIt is widely accepted that the relationship between lightning wildfire occurrence and its influencing factors vary depending on the spatial scale of analysis, making the development of models at the regional scale advisable. In this study, we analyze the effects of different biophysical variables and lightning characteristics on lightning‐caused forest wildfires in Castilla y León region (Central Spain). The presence/absence of at least one lightning‐caused fire in any 4 × 4‐km grid cell was used as a dependent variable and vegetation type and structure, terrain, climate, and lightning characteristics were used as possible covariates. Five prediction methods were compared: a generalized linear model (GLM), a random forest model (RFM), a generalized additive model (GAM), a GAM that includes a spatial trend function (GAMs) and a spatial autoregressive model (AUREG). A GAMs with just one covariate, apart from longitude and latitude for each observation included as a combined effect, was considered the most appropriate model in terms of both predictive ability and simplicity. According to our results, the probability of a forest being affected by a lightning‐caused fire is positively and nonlinearly associated with the percentage of coniferous woodlands in the landscape, suggesting that occurrence is more closely associated with vegetation type than with topography, climate, or lightning characteristics. The selected GAMs is intended to inform the Regional Government of Castilla y León (the fire and fuel agency in the region) regarding identification of areas at greatest risk so it can design long‐term forest fuel and fire management strategies.

P. 441-452 ; The European Union requires member states to estimate their wine growing potential. For this porpose, most member states have developed or updated vineyard registers. The present study suggests locating vineyards using medium spatial resolution satellite imagery. The work was carried out using Landsat images that were validated for the Designation of Origin "Bierzo", León, Spain ; SI