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الصفحة 1
الصفحة 1
Laboratory control system operations in a GMP environment
In Laboratory Control System Operations in a GMP Environment, readers are given the guidance they need to implement a CGMP compliant Laboratory Control System (LCS) that fits within Global Regulatory guidelines. Using the Quality Systems Approach, regulatory agencies like the FDA and the European Medicine Agency have developed a scheme of systems for auditing pharmaceutical manufacturing facilities which includes evaluating the LCS.
Biopharmaceutical manufacturing progress, trends and challenges
Source of the latest innovative research and technical development in biomanufacturing systems. It is organised into 2 parts: 1) Manufacturing of recombinant therapeutic proteins (e.g. therapeutic antibodies, biosimilars/biogenerics) and 2) Manufacturing aspects of cell and gene therapy. Each with selected chapters on the following topics for both up- and downstream, such as: Advanced process strategies, especially continuous manufacturing, Advanced culture techniques, especially single-use systems, Process transfer, scale-up/scale-down models, Processing advances/Manufacturing productivity/efficiency, Model-assisted process understanding and development/Digital Twins, Process controls and analytics, Quality control, Quality by design, Facility design and full-scale commercial systems, manufacturing technology innovation.
Bacteriophage therapy: From lab to clinical practice
Details new and updated experimental approaches for isolating, formulating, and engineering bacteriophage medicinal products. Authored by leading experts and written in the highly successful Methods in Molecular Biology series format, each chapter includes introductions to their respective topics, lists of the necessary materials and reagents, step-by-step reproducible laboratory protocols, and valuable tips for troubleshooting and avoiding known pitfalls.
Applied Civil Engineering Risk Analysis
Povides readers with the tools needed to determine the probability of failure, and when multiplied by the consequences of failure, illustrates how to assess the risk of civil engineering problems. Presenting methods for quantifying uncertainty that exists in engineering analysis and design, with an emphasis on fostering more accurate analysis and design.
Managing the Complexity of Critical Infrastructures : A Modelling and Simulation Approach
This book summarizes work being pursued in the context of the CIPRNet (Critical Infrastructure Preparedness and Resilience Research Network) research project, co-funded by the European Union under the Seventh Framework Programme (FP7). The project is intended to provide concrete and on-going support to the Critical Infrastructure Protection (CIP) research communities, enhancing their preparedness for CI-related emergencies, while also providing expertise and technologies for other stakeholders to promote their understanding and mitigation of the consequences of CI disruptions, leading to enhanced resilience.
Lifetime Estimation of Welded Joints
In the paper the author attempts to assess the fatigue life of chosen welded joints. It focuses especially on chosen problems that accompany deter- nation of the fatigue life of welded joints, taking into consideration the strain energy density parameter.
Climatic Changes and Water Resources in the Middle East and North Africa
The subject is described and discussed in three main chapters and different case studies.All topics in this book are complimentary and contribute to a comprehensive understanding of the interactions between global climate change, world water cycle and water resources. A valuable and meaningful interdisciplinary mixture of topics is combined in this book.
Chromatography for Sustainable Polymeric Materials : Renewable, Degradable and Recyclable
This volume is a valuable contribution to sustainability research. … This interesting, well-written book provides the reader with an excellent resource on how to effectively use simple chromatographic techniques to aid in determining processing conditions, additive formulations, quality control, service life, degradation pathways, and more.
Challenges in Radiation Protection and Nuclear Safety Regulation of the Nuclear Legacy
The book covers radiation protection and nuclear safety supervision of installations built during the cold war, particularly in relation to regulatory strategies for safe decommissioning of unique or unusual nuclear facilities and remediation
Catalogue of risks : Natural, technical, social and health risks
The book clearly shows the interdependence of risk measures. Safety and risks cannot be discussed only by looking at specific problems, since increasing safety in individual fields might lead to a decrease of safety over the entire society.
Blast Cleaning Technology
Blast cleaning is one of the most frequently utilised surface treatment-method in modern industry. The book is the first comprehensive monograph in this subject. It provides a practical and comprehensive review of the technology. This book systematically and critically reviews the theory behind the technology, the state of current blast cleaning, surface quality aspects and the effects of blast cleaning on the performance of applied coatings.
Bayesian reliability
Bayesian Reliability presents modern methods and techniques for analyzing reliability data from a Bayesian perspective. The adoption and application of Bayesian methods in virtually all branches of science and engineering have significantly increased over the past few decades. This increase is largely due to advances in simulation-based computational tools for implementing Bayesian methods. The authors extensively use such tools throughout this book, focusing on assessing the reliability of components and systems with particular attention to hierarchical models and models incorporating explanatory variables. Such models include failure time regression models, accelerated testing models, and degradation models. The authors pay special attention to Bayesian goodness-of-fit testing, model validation, reliability test design, and assurance test planning. Throughout the book, the authors use Markov chain Monte Carlo (MCMC) algorithms for implementing Bayesian analyses--algorithms that make the Bayesian approach to reliability computationally feasible and conceptually straightforward.
Applied Reliability and Quality : Fundamentals, Methods and Procedures
"Reliability and quality professionals need to know about each other's work activities because this may help them - directly or indirectly - to perform their tasks more effectively. Applied Reliability and Quality: Fundamentals, Methods and Procedures meets the need for a single volume that considers applied areas of both reliability and quality. Before now, there has not been one book that covers both applied reliability and quality; so to gain knowledge of each other's specialties, these people had to study various books, articles, or reports on each area."
Analysis of variance for random models, Vol. 2 : Unbalanced data : Theory, methods, applications, and data analysis
Analysis of variance (ANOVA) models have become widely used tools and play a fundamental role in much of the application of statistics today. In particular, ANOVA models involving random effects have found widespread application to experimental design in a variety of fields requiring measurements of variance, including agriculture, biology, animal breeding, applied genetics, econometrics, quality control, medicine, engineering, and social sciences. This two-volume work is a comprehensive presentation of different methods and techniques for point estimation, interval estimation, and tests of hypotheses for linear models involving random effects. Both Bayesian and repeated sampling procedures are considered. Volume I examines models with balanced data (orthogonal models); Volume II studies models with unbalanced data (nonorthogonal models).
AiREAS : Sustainocracy for a healthy city : Phase 3 : Civilian participation – Including the global health deal proposition
This volume describes phase 3 of the AiREAS multidisciplinary cocreation effort to produce a Healthy City. Phase 1 referred to making visible the invisible from an air quality and human exposure perspective. Phase 2 studies air quality related to health and Phase 3 looks at air quality, health and lifestyle from the perspective of persuasion to innovative change. The three books together describe the coming about and first results of the AiREAS "healthy city" cooperative in the city of Eindhoven and Province of North Brabant in the Netherlands. AiREAS is an initiative focused on the multidisciplinary co-creation of healthy cities using the core human value of human health and air quality as guiding principle for profound regional innovation.
Air quality integrated assessment : A European perspective
This book reports on the results of an extended survey conducted across Europe within the framework of the APPRAISAL FP7 project to determine the extent to which an integrated assessment approach to air quality is being adopted, on the one hand, by regional and local authorities to develop air quality plans and, on the other, by researchers. Following a detailed analysis of the role and structure of the components of an integrated assessment study, the results of the survey are considered from a variety of perspectives.
Air Pollution Modeling and Its Application XIX
The book is aimed at researchers and government policy makers who wish to keep abreast of the most recent developments in air pollution modelling and air quality issues. The book emphasizes the following key topics: 1. Local and urban scale modelling; 2. Regional and intercontinental modelling; 3. Data assimilation and air quality forecast; 4. Model assessment and verification; 5. Aerosols in the atmosphere; 6. Interactions between air quality and climate change; 7. Air quality and human health.
Aerosol Optics : Light Absorption and Scattering by Particles in the Atmosphere
Provides a comprehensive review of available techniques for the remote sensing of aerosols. Although mostly satellite remote sensing is considered, ground-based techniques are also discussed.describes techniques for the determination of the column concentration of aerosol particles and their optical sizing using spaceborne optical instrumentation. The majority of the techniques described in this book use a so-called "library method". This method relies upon the precalculated top-of-atmosphere reflectances (TOAR) for vaious atmospheric aerosol types. The comparison of measured and calculated TOARS allows one to characterize the optically-equivalent aerosol state.
Advances in Mathematical and Statistical Modeling
Enrique Castillo is a leading figure in several mathematical, statistical, and engineering fields, having contributed seminal work in such areas as statistical modeling, extreme value analysis, multivariate distribution theory, Bayesian networks, neural networks, functional equations, artificial intelligence, linear algebra, optimization methods, numerical methods, reliability engineering, as well as sensitivity analysis and its applications. Organized to honor Castillo's significant contributions, this volume is an outgrowth of the International Conference on Mathematical and Statistical Modeling and covers recent advances in the field. Also presented are applications to safety, reliability and life-testing, financial modeling, quality control, general inference, as well as neural networks and computational techniques.
Advances in Industrial Engineering and Operations Research
Advances in Industrial Engineering and Operations Research compiles revised and extended articles written by prominent researchers participating in the International MultiConference of Engineers and Computer Scientists (IMECS) 2007. This volume addresses manufacturing processes and methods, optimization, experimental engineering design, and reliability and quality control techniques.
