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Author : Jonathan F. Luedeke
Publisher :
ISBN 13 :
Total Pages : 158 pages
Book Rating : 4.:/5 (1 download)
Download or read book Development of a safety validation methodology written by Jonathan F. Luedeke and published by . This book was released on 1995 with total page 158 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : National Research Council
Publisher : National Academies Press
ISBN 13 : 030904880X
Total Pages : 207 pages
Book Rating : 4.3/5 (9 download)
Download or read book An Assessment of Space Shuttle Flight Software Development Processes written by National Research Council and published by National Academies Press. This book was released on 1993-02-01 with total page 207 pages. Available in PDF, EPUB and Kindle. Book excerpt: Effective software is essential to the success and safety of the Space Shuttle, including its crew and its payloads. The on-board software continually monitors and controls critical systems throughout a Space Shuttle flight. At NASA's request, the committee convened to review the agency's flight software development processes and to recommend a number of ways those processes could be improved. This book, the result of the committee's study, evaluates the safety, oversight, and management functions that are implemented currently in the Space Shuttle program to ensure that the software is of the highest quality possible. Numerous recommendations are made regarding safety and management procedures, and a rationale is offered for continuing the Independent Verification and Validation effort that was instituted after the Challenger Accident.
Author :
Publisher :
ISBN 13 :
Total Pages : 1060 pages
Book Rating : 4.3/5 (243 download)
Download or read book Code of Federal Regulations written by and published by . This book was released on 2010 with total page 1060 pages. Available in PDF, EPUB and Kindle. Book excerpt: Special edition of the Federal Register, containing a codification of documents of general applicability and future effect ... with ancillaries.
Author : Robert F. DeVellis
Publisher : SAGE Publications
ISBN 13 : 1506341586
Total Pages : 160 pages
Book Rating : 4.5/5 (63 download)
Download or read book Scale Development written by Robert F. DeVellis and published by SAGE Publications. This book was released on 2016-03-30 with total page 160 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the Fourth Edition of Scale Development, Robert F. DeVellis demystifies measurement by emphasizing a logical rather than strictly mathematical understanding of concepts. The text supports readers in comprehending newer approaches to measurement, comparing them to classical approaches, and grasping more clearly the relative merits of each. This edition addresses new topics pertinent to modern measurement approaches and includes additional exercises and topics for class discussion. Available with Perusall—an eBook that makes it easier to prepare for class Perusall is an award-winning eBook platform featuring social annotation tools that allow students and instructors to collaboratively mark up and discuss their SAGE textbook. Backed by research and supported by technological innovations developed at Harvard University, this process of learning through collaborative annotation keeps your students engaged and makes teaching easier and more effective. Learn more.
Author :
Publisher :
ISBN 13 :
Total Pages : 912 pages
Book Rating : 4.F/5 ( download)
Download or read book The Code of Federal Regulations of the United States of America written by and published by . This book was released on with total page 912 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Code of Federal Regulations is the codification of the general and permanent rules published in the Federal Register by the executive departments and agencies of the Federal Government.
Author : David A. Vogel
Publisher : Artech House
ISBN 13 : 1596934239
Total Pages : 445 pages
Book Rating : 4.5/5 (969 download)
Download or read book Medical Device Software Verification, Validation and Compliance written by David A. Vogel and published by Artech House. This book was released on 2011 with total page 445 pages. Available in PDF, EPUB and Kindle. Book excerpt: HereOCOs the first book written specifically to help medical device and software engineers, QA and compliance professionals, and corporate business managers better understand and implement critical verification and validation processes for medical device software.Offering you a much broader, higher-level picture than other books in this field, this book helps you think critically about software validation -- to build confidence in your softwareOCOs safety and effectiveness. The book presents validation activities for each phase of the development lifecycle and shows: why these activities are important and add value; how to undertake them; and what outputs need to be created to document the validation process.From software embedded within medical devices, to software that performs as a medical device itself, this comprehensive book explains how properly handled validation throughout the development lifecycle can help bring medical devices to completion sooner, at higher quality, in compliance with regulations."
Author : Jairus R. D. David
Publisher : CRC Press
ISBN 13 : 1000631095
Total Pages : 702 pages
Book Rating : 4.0/5 (6 download)
Download or read book Handbook of Aseptic Processing and Packaging written by Jairus R. D. David and published by CRC Press. This book was released on 2022-09-07 with total page 702 pages. Available in PDF, EPUB and Kindle. Book excerpt: Nine years have passed since the second edition of the Handbook of Aseptic Processing and Packaging was published. Significant changes have taken place in several aseptic processing and packaging areas. These include aseptic filling of plant-based beverages for non-refrigerated shelf-stable formats for longer shelf life and sustainable packaging along with cost of environmental benefits to leverage savings on energy and carbon footprint. In addition, insight into safe processing of particulates using two- and three-dimensional thermal processing followed by prompt cooling is provided. In the third edition, the editors have compiled contemporary topics with information synthesized from internationally recognized authorities in their fields. In addition to updated information, 12 new chapters have been added in this latest release with content on Design of the aseptic processing system and thermal processing Thermal process equipment and technology for heating and cooling Flow and residence time distribution (RTD) for homogeneous and heterogeneous fluids Thermal process and optimization of aseptic processing containing solid particulates Aseptic filling and packaging equipment for retail products and food service Design of facility, infrastructure, and utilities Cleaning and sanitization for aseptic processing and packaging operations Microbiology of aseptically processed and packaged products Risk-based analyses and methodologies Establishment of "validated state" for aseptic processing and packaging systems Quality and food safety management systems for aseptic and extended shelf life (ESL) manufacturing Computational and numerical models and simulations for aseptic processing Also, there are seven new appendices on original patents, examples of typical thermal process calculations, and particulate studies—single particle and multiple-type particles, and Food and Drug Administration (FDA) filing The three editors and 22 contributors to this volume have more than 250 years of combined experience encompassing manufacturing, innovation in processing and packaging, R&D, quality assurance, and compliance. Their insight provides a comprehensive update on this rapidly developing leading-edge technology for the food processing industry. The future of aseptic processing and packaging of foods and beverages will be driven by customer-facing convenience and taste, use of current and new premium clean label natural ingredients, use of multifactorial preservation or hurdle technology for maximizing product quality, and sustainable packaging with claims and messaging.
Author : Fiona Davies
Publisher :
ISBN 13 : 9780717619580
Total Pages : 45 pages
Book Rating : 4.6/5 (195 download)
Download or read book Summary Guide to Safety Climate Tools written by Fiona Davies and published by . This book was released on 2001 with total page 45 pages. Available in PDF, EPUB and Kindle. Book excerpt: Summary Guide to Safety Climate Tools
Author : Christopher M. Riley
Publisher : Elsevier
ISBN 13 : 0080530354
Total Pages : 363 pages
Book Rating : 4.0/5 (85 download)
Download or read book Development and Validation of Analytical Methods written by Christopher M. Riley and published by Elsevier. This book was released on 1996-05-29 with total page 363 pages. Available in PDF, EPUB and Kindle. Book excerpt: The need to validate an analytical or bioanalytical method is encountered by analysts in the pharmaceutical industry on an almost daily basis, because adequately validated methods are a necessity for approvable regulatory filings. What constitutes a validated method, however, is subject to analyst interpretation because there is no universally accepted industry practice for assay validation. This book is intended to serve as a guide to the analyst in terms of the issues and parameters that must be considered in the development and validation of analytical methods. In addition to the critical issues surrounding method validation, this book also deals with other related factors such as method development, data acquisition, automation, cleaning validation and regulatory considerations. The book is divided into three parts. Part One, comprising two chapters, looks at some of the basic concepts of method validation. Chapter 1 discusses the general concept of validation and its role in the process of transferring methods from laboratory to laboratory. Chapter 2 looks at some of the critical parameters included in a validation program and the various statistical treatments given to these parameters.Part Two (Chapters 3, 4 and 5) of the book focuses on the regulatory perspective of analytical validation. Chapter 3 discusses in some detail how validation is treated by various regulatory agencies around the world, including the United States, Canada, the European Community, Australia and Japan. This chapter also discusses the International Conference on Harmonization (ICH) treatment of assay validation. Chapters 4 and 5 cover the issues and various perspectives of the recent United States vs. Barr Laboratories Inc. case involving the retesting of samples. Part Three (Chapters 6 - 12) covers the development and validation of various analytical components of the pharmaceutical product development process. This part of the book contains specific chapters dedicated to bulk drug substances and finished products, dissolution studies, robotics and automated workstations, biotechnology products, biological samples, analytical methods for cleaning procedures and computer systems and computer-aided validation. Each chapter goes into some detail describing the critical development and related validation considerations for each topic.This book is not intended to be a practical description of the analytical validation process, but more of a guide to the critical parameters and considerations that must be attended to in a pharmaceutical development program. Despite the existence of numerous guidelines including the recent attempts by the ICH to be implemented in 1998, the practical part of assay validation will always remain, to a certain extent, a matter of the personal preference of the analyst or company. Nevertheless, this book brings together the perspectives of several experts having extensive experience in different capacities in the pharmaceutical industry in an attempt to bring some consistency to analytical method development and validation.
Author : United States. Congress. House. Committee on Appropriations. Subcommittee on the Departments of Transportation and Treasury, and Independent Agencies Appropriations
Publisher :
ISBN 13 :
Total Pages : 1904 pages
Book Rating : 4.:/5 (319 download)
Download or read book Departments of Transportation and Treasury, and Independent Agencies Appropriations for 2005 written by United States. Congress. House. Committee on Appropriations. Subcommittee on the Departments of Transportation and Treasury, and Independent Agencies Appropriations and published by . This book was released on 2004 with total page 1904 pages. Available in PDF, EPUB and Kindle. Book excerpt: Distributed to some depository libraries in microfiche.
Author : Chantra Eskes
Publisher : Springer
ISBN 13 : 3319338269
Total Pages : 418 pages
Book Rating : 4.3/5 (193 download)
Download or read book Validation of Alternative Methods for Toxicity Testing written by Chantra Eskes and published by Springer. This book was released on 2016-09-26 with total page 418 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides information on best practices and new thinking regarding the validation of alternative methods for toxicity testing. It covers the validation of experimental and computational methods and integrated approaches to testing and assessment. Validation strategies are discussed for methods employing the latest technologies such as tissue-on-a-chip systems, stem cells and transcriptomics, and for methods derived from pathway-based concepts in toxicology. Validation of Alternative Methods for Toxicity Testing is divided into two sections, in the first, practical insights are given on the state-of-the-art and on approaches that have resulted in successfully validated and accepted alternative methods. The second section focuses on the evolution of validation principles and practice that are necessary to ensure fit-for-purpose validation that has the greatest impact on international regulatory acceptance of alternative methods. In this context validation needs to keep pace with the considerable scientific advancements being made in toxicology, the availability of sophisticated tools and techniques that can be applied in a variety of ways, and the increasing societal and regulatory demands for better safety assessment. This book will be a useful resource for scientists in the field of toxicology, both from industry and academia, developing new test methods, strategies or techniques, as well as Governmental and regulatory authorities interested in understanding the principles and practicalities of validation of alternative methods for toxicity testing.
Author : Kerm Henriksen
Publisher :
ISBN 13 :
Total Pages : 526 pages
Book Rating : 4.7/5 (54 download)
Download or read book Advances in Patient Safety written by Kerm Henriksen and published by . This book was released on 2005 with total page 526 pages. Available in PDF, EPUB and Kindle. Book excerpt: v. 1. Research findings -- v. 2. Concepts and methodology -- v. 3. Implementation issues -- v. 4. Programs, tools and products.
Author : Gary Eugene Musgrave
Publisher : Butterworth-Heinemann
ISBN 13 : 0080559220
Total Pages : 988 pages
Book Rating : 4.0/5 (85 download)
Download or read book Safety Design for Space Systems written by Gary Eugene Musgrave and published by Butterworth-Heinemann. This book was released on 2009-03-27 with total page 988 pages. Available in PDF, EPUB and Kindle. Book excerpt: Progress in space safety lies in the acceptance of safety design and engineering as an integral part of the design and implementation process for new space systems. Safety must be seen as the principle design driver of utmost importance from the outset of the design process, which is only achieved through a culture change that moves all stakeholders toward front-end loaded safety concepts. This approach entails a common understanding and mastering of basic principles of safety design for space systems at all levels of the program organisation. Fully supported by the International Association for the Advancement of Space Safety (IAASS), written by the leading figures in the industry, with frontline experience from projects ranging from the Apollo missions, Skylab, the Space Shuttle and the International Space Station, this book provides a comprehensive reference for aerospace engineers in industry. It addresses each of the key elements that impact on space systems safety, including: the space environment (natural and induced); human physiology in space; human rating factors; emergency capabilities; launch propellants and oxidizer systems; life support systems; battery and fuel cell safety; nuclear power generators (NPG) safety; habitat activities; fire protection; safety-critical software development; collision avoidance systems design; operations and on-orbit maintenance. - The only comprehensive space systems safety reference, its must-have status within space agencies and suppliers, technical and aerospace libraries is practically guaranteed - Written by the leading figures in the industry from NASA, ESA, JAXA, (et cetera), with frontline experience from projects ranging from the Apollo missions, Skylab, the Space Shuttle, small and large satellite systems, and the International Space Station - Superb quality information for engineers, programme managers, suppliers and aerospace technologists; fully supported by the IAASS (International Association for the Advancement of Space Safety)
Author : Mike Furr
Publisher : SAGE
ISBN 13 : 1446209482
Total Pages : 161 pages
Book Rating : 4.4/5 (462 download)
Download or read book Scale Construction and Psychometrics for Social and Personality Psychology written by Mike Furr and published by SAGE. This book was released on 2011-02-15 with total page 161 pages. Available in PDF, EPUB and Kindle. Book excerpt: Providing conceptual and practical foundations in scale construction and psychometrics for producers and consumers of social/personality research, this guide covers basic principles, practices, and processes in scale construction, scale evaluation, scale use, and interpretation of research results in the context of psychological measurement. It explains fundamental concepts and methods related to dimensionality, reliability, and validity. In addition, it provides relatively non-technical introductions to special topics and advanced psychometric perspectives such as Confirmatory Factor Analysis, Generalizability Theory, and Item Response Theory. The SAGE Library in Social and Personality Psychology Methods provides students and researchers with an understanding of the methods and techniques essential to conducting cutting-edge research. Each volume within the Library explains a specific topic and has been written by an active scholar (or scholars) with expertise in that particular methodological domain. Assuming no prior knowledge of the topic, the volumes are clear and accessible for all readers. In each volume, a topic is introduced, applications are discussed, and readers are led step by step through worked examples. In addition, advice about how to interpret and prepare results for publication are presented.
Author : United States. Congress. House. Committee on Government Operations. Government Activities and Transportation Subcommittee
Publisher :
ISBN 13 :
Total Pages : 100 pages
Book Rating : 4.3/5 (91 download)
Download or read book FAA's Regulation by Objective Proposal written by United States. Congress. House. Committee on Government Operations. Government Activities and Transportation Subcommittee and published by . This book was released on 1983 with total page 100 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Uwe Glässer
Publisher : Springer Nature
ISBN 13 : 303133163X
Total Pages : 386 pages
Book Rating : 4.0/5 (313 download)
Download or read book Rigorous State-Based Methods written by Uwe Glässer and published by Springer Nature. This book was released on 2023-05-14 with total page 386 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book constitutes the refereed proceedings of the 9th International Conference on Rigorous State-Based Methods, ABZ 2023, held in Nancy, France, in May 2023. The 12 full and 7 short papers included in this volume were carefully reviewed and selected from 47 submissions. The proceedings also include 4 PhD symposium contributions. They deal with state-based and machine-based formal methods, mainly Abstract State Machines (ASM), Alloy, B, TLA+, VDM, and Z.
Author : Dr. Oladokun S. Olanrewaju
Publisher : Xlibris Corporation
ISBN 13 : 1493109324
Total Pages : 295 pages
Book Rating : 4.4/5 (931 download)
Download or read book Risk Based Design for Safe Development of Reliable and Environmentally Friendly Inland Water Transportation System written by Dr. Oladokun S. Olanrewaju and published by Xlibris Corporation. This book was released on 2013-10-17 with total page 295 pages. Available in PDF, EPUB and Kindle. Book excerpt: Water supports our planet and its vast resources need to be fully utilized to benefit human activities and his environment in a sustainable manner, most of inland water resources has been under utilised and under maintained. Maritime industry has made use of the ocean in a more much responsible manner for cross continental transportation of good. There are currently dire needs to find sensitive ways to mitigate challenge of global warming, climate changes and its associated impact, especially within the coastline. Various research works has proven that Inland Water Transportation represents the cleanest mode of transportation. Its use could reduce and mitigate carbon footage and other Green House Gases. Past system design and operation has followed conventional method. System has been addressed through reactive behaviour that has put system on probable risk and consequence in oblivion. Likewise, complexity of sustainable water transportation development demand design and operation that require careful evaluation which can be achieved by employing proactive method. That considers holistic system analysis approach. It has become important to address system associated risk, reliability and their life cycle through assessment of accident and pollution prevention, protection, control principle. Ageing, uncertainty and operational factors are also important system variables that need to be incorporated in risk close loop system. This book account for modelling of proactive technik and application of a top down risk and reliability based design that identifies assess, analyses and employ sustainability equity comparison leading to generic safety and environmental risk reliability model (SERM). SERM is a decision support system tool developed at University Technology Malaysia for the development of efficient and sustainable Inland Water Transportation System (IWT).
