International IT Regulations and Compliance

International IT Regulations and Compliance
Author: Siri H. Segalstad
Publsiher: John Wiley & Sons
Total Pages: 338
Release: 2008-11-20
ISBN: 9780470721834
Category: Law
Language: EN, FR, DE, ES & NL

International IT Regulations and Compliance Book Excerpt:

Standards, technologies, and requirements for computer validation have changed dramatically in recent years, and so have the interpretation of the standards and the understanding of the processes involved. International IT Regulations and Compliance brings together current thinking on the implementation of standards and regulations in relation to IT for a wide variety of industries. The book provides professionals in pharmaceutical and semiconductor industries with an updated overview of requirements for handling IT systems according to various Quality Standards and how to ?translate? these requirements in the regulations.

Validation of Chromatography Data Systems

Validation of Chromatography Data Systems
Author: Robert D. McDowall
Publsiher: Royal Society of Chemistry
Total Pages: 733
Release: 2016-11-25
ISBN: 1849736626
Category: Science
Language: EN, FR, DE, ES & NL

Validation of Chromatography Data Systems Book Excerpt:

Guiding chromatographers working in regulated industries and helping them to validate their chromatography data systems to meet data integrity, business and regulatory needs. This book is a detailed look at the life cycle and documented evidence required to ensure a system is fit for purpose throughout the lifecycle. Initially providing the regulatory, data integrity and system life cycle requirements for computerised system validation, the book then develops into a guide on planning, specifying, managing risk, configuring and testing a chromatography data system before release. This is followed by operational aspects such as training, integration and IT support and finally retirement. All areas are discussed in detail with case studies and practical examples provided as appropriate. The book has been carefully written and is right up to date including recently released FDA data integrity guidance. It provides detailed guidance on good practice and expands on the first edition making it an invaluable addition to a chromatographer’s book shelf.

Mrs Gamp By Charles Dickens As condensed by himself for his readings With an illustration by S Eytinge Jr

Mrs  Gamp  By Charles Dickens  As condensed by himself  for his readings  With an illustration by S  Eytinge  Jr
Author: Charles Dickens
Publsiher: Unknown
Total Pages: 18
Release: 1868
ISBN: 1928374650XXX
Category: Electronic Book
Language: EN, FR, DE, ES & NL

Mrs Gamp By Charles Dickens As condensed by himself for his readings With an illustration by S Eytinge Jr Book Excerpt:

Medical Device Software Verification Validation and Compliance

Medical Device Software Verification  Validation and Compliance
Author: David A. Vogel
Publsiher: Artech House
Total Pages: 444
Release: 2010
ISBN: 1596934239
Category: Biomedical engineering
Language: EN, FR, DE, ES & NL

Medical Device Software Verification Validation and Compliance 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."

Data Integrity and Data Governance

Data Integrity and Data Governance
Author: R. D. McDowall
Publsiher: Royal Society of Chemistry
Total Pages: 660
Release: 2018-11-09
ISBN: 178801281X
Category: Science
Language: EN, FR, DE, ES & NL

Data Integrity and Data Governance Book Excerpt:

This book provides practical and detailed advice on how to implement data governance and data integrity for regulated analytical laboratories working in the pharmaceutical and allied industries.

Validation of Chromatography Data Systems

Validation of Chromatography Data Systems
Author: Robert McDowall
Publsiher: Royal Society of Chemistry
Total Pages: 290
Release: 2007-10-31
ISBN: 1847552293
Category: Science
Language: EN, FR, DE, ES & NL

Validation of Chromatography Data Systems Book Excerpt:

Chromatography is a major analytical technique that is used throughout research, development and manufacturing in the pharmaceutical, medical device and associated industries. To demonstrate fitness for purpose with the applicable regulations, the systems must be validated. Validation of Chromatography Data Systems: Meeting Business and Regulatory Requirements introduces the basics of computer validation. It looks in detail at the requirements throughout the life cycle of a CDS for any regulated laboratory, from its concept, through writing the user requirements specification to selecting the system, testing and operational release, including using electronic signatures. This logical and uniquely organised book provides the background to the regulatory requirements, interpretation of the regulations and documented evidence needed to support a claim that a system is validated. Development of the system, risk management, operation and finally system retirement and data migration are discussed. Case studies and practical examples are provided where appropriate. Validation of Chromatography Data Systems: Meeting Business and Regulatory Requirements is ideal for the chromatographer working in analytical laboratories in the regulated pharmaceutical, contract research, biotechnology and medical device industries seeking the practical guidance required for validating their chromatography data systems in order to meet regulatory requirements. It will also be welcomed by consultants or those in regulatory agencies.

Analytical Testing for the Pharmaceutical GMP Laboratory

Analytical Testing for the Pharmaceutical GMP Laboratory
Author: Kim Huynh-Ba
Publsiher: John Wiley & Sons
Total Pages: 416
Release: 2022-04-19
ISBN: 1119120918
Category: Science
Language: EN, FR, DE, ES & NL

Analytical Testing for the Pharmaceutical GMP Laboratory Book Excerpt:

Provides practical guidance on pharmaceutical analysis, written by leading experts with extensive industry experience Analytical Testing for the Pharmaceutical GMP Laboratory presents a thorough overview of the pharmaceutical regulations, working processes, and drug development best practices used to maintain the quality and integrity of medicines. With a focus on smaller molecular weight drug substances and products, the book provides the knowledge necessary for establishing the pharmaceutical laboratory to support Quality Systems while maintaining compliance with Good Manufacturing Practices (GMP) regulations. Concise yet comprehensive chapters contain up-to-date coverage of drug regulations, pharmaceutical analysis methodologies, control strategies, testing development and validation, method transfer, electronic data documentation, and more. Each chapter includes a table of contents, definitions of acronyms, a reference list, and ample tables and figures. Addressing the principal activities and regulatory challenges of analytical testing in the development and manufacturing of pharmaceutical drug products, this authoritative resource: Describes the structure, roles, core guidelines, and GMP regulations of the FDA and ICH. Covers the common analytical technologies used in pharmaceutical laboratories, including examples of analytical techniques used for the release and stability testing of drugs. Examines control strategies established from quality systems supported by real-world case studies. Explains the use of dissolution testing for products such as extended-release capsules, aerosols, and inhalers. Discusses good documentation and data reporting practices, stability programs, and the Laboratory Information Management System (LIMS) to maintain compliance. Includes calculations, application examples, and illustrations to assist readers in day-to-day laboratory operations. Contains practical information and templates to structure internal processes or common Standard Operating Procedures (SOPs). Analytical Testing for the Pharmaceutical GMP Laboratory is a must-have reference for both early-career and experienced pharmaceutical scientists, analytical chemists, pharmacists, and quality control professionals. It is also both a resource for GMP laboratory training programs and an excellent textbook for undergraduate and graduate courses of analytical chemistry in pharmaceutical sciences or regulatory compliance programs.

Parallel and Distributed Computing Applications and Technologies

Parallel and Distributed Computing  Applications and Technologies
Author: Jong Hyuk Park,Hong Shen,Yunsick Sung,Hui Tian
Publsiher: Springer
Total Pages: 484
Release: 2019-02-07
ISBN: 9811359075
Category: Computers
Language: EN, FR, DE, ES & NL

Parallel and Distributed Computing Applications and Technologies Book Excerpt:

This book constitutes the refereed proceedings of the 19th International Conference on CParallel and Distributed Computing, Applications and Technologies, PDCAT 2018, held in Jeju Island, South Korea, in August 2018. The 35 revised full papers presented along with the 14 short papers and were carefully reviewed and selected from 150 submissions. The papers of this volume are organized in topical sections on wired and wireless communication systems, high dimensional data representation and processing, networks and information security, computing techniques for efficient networks design, electronic circuits for communication systems.

Instrument Engineers Handbook

Instrument Engineers  Handbook
Author: Bela G. Liptak,Halit Eren
Publsiher: CRC Press
Total Pages: 1139
Release: 2011-08-19
ISBN: 1439817766
Category: Technology & Engineering
Language: EN, FR, DE, ES & NL

Instrument Engineers Handbook Book Excerpt:

Instrument Engineers' Handbook – Volume 3: Process Software and Digital Networks, Fourth Edition is the latest addition to an enduring collection that industrial automation (AT) professionals often refer to as the "bible." First published in 1970, the entire handbook is approximately 5,000 pages, designed as standalone volumes that cover the measurement (Volume 1), control (Volume 2), and software (Volume 3) aspects of automation. This fourth edition of the third volume provides an in-depth, state-of-the-art review of control software packages used in plant optimization, control, maintenance, and safety. Each updated volume of this renowned reference requires about ten years to prepare, so revised installments have been issued every decade, taking into account the numerous developments that occur from one publication to the next. Assessing the rapid evolution of automation and optimization in control systems used in all types of industrial plants, this book details the wired/wireless communications and software used. This includes the ever-increasing number of applications for intelligent instruments, enhanced networks, Internet use, virtual private networks, and integration of control systems with the main networks used by management, all of which operate in a linked global environment. Topics covered include: Advances in new displays, which help operators to more quickly assess and respond to plant conditions Software and networks that help monitor, control, and optimize industrial processes, to determine the efficiency, energy consumption, and profitability of operations Strategies to counteract changes in market conditions and energy and raw material costs Techniques to fortify the safety of plant operations and the security of digital communications systems This volume explores why the holistic approach to integrating process and enterprise networks is convenient and efficient, despite associated problems involving cyber and local network security, energy conservation, and other issues. It shows how firewalls must separate the business (IT) and the operation (automation technology, or AT) domains to guarantee the safe function of all industrial plants. This book illustrates how these concerns must be addressed using effective technical solutions and proper management policies and practices. Reinforcing the fact that all industrial control systems are, in general, critically interdependent, this handbook provides a wide range of software application examples from industries including: automotive, mining, renewable energy, steel, dairy, pharmaceutical, mineral processing, oil, gas, electric power, utility, and nuclear power.

24th European Symposium on Computer Aided Process Engineering

24th European Symposium on Computer Aided Process Engineering
Author: Anonim
Publsiher: Elsevier
Total Pages: 1954
Release: 2014-06-20
ISBN: 0444634436
Category: Technology & Engineering
Language: EN, FR, DE, ES & NL

24th European Symposium on Computer Aided Process Engineering Book Excerpt:

The 24th European Symposium on Computer Aided Process Engineering creates an international forum where scientific and industrial contributions of computer-aided techniques are presented with applications in process modeling and simulation, process synthesis and design, operation, and process optimization. The organizers have broadened the boundaries of Process Systems Engineering by inviting contributions at different scales of modeling and demonstrating vertical and horizontal integration. Contributions range from applications at the molecular level to the strategic level of the supply chain and sustainable development. They cover major classical themes, at the same time exploring a new range of applications that address the production of renewable forms of energy, environmental footprints and sustainable use of resources and water.

Encyclopedia of Software Engineering Three Volume Set Print

Encyclopedia of Software Engineering Three Volume Set  Print
Author: Phillip A. Laplante
Publsiher: CRC Press
Total Pages: 1522
Release: 2010-11-22
ISBN: 1351249258
Category: Computers
Language: EN, FR, DE, ES & NL

Encyclopedia of Software Engineering Three Volume Set Print Book Excerpt:

Software engineering requires specialized knowledge of a broad spectrum of topics, including the construction of software and the platforms, applications, and environments in which the software operates as well as an understanding of the people who build and use the software. Offering an authoritative perspective, the two volumes of the Encyclopedia of Software Engineering cover the entire multidisciplinary scope of this important field. More than 200 expert contributors and reviewers from industry and academia across 21 countries provide easy-to-read entries that cover software requirements, design, construction, testing, maintenance, configuration management, quality control, and software engineering management tools and methods. Editor Phillip A. Laplante uses the most universally recognized definition of the areas of relevance to software engineering, the Software Engineering Body of Knowledge (SWEBOK®), as a template for organizing the material. Also available in an electronic format, this encyclopedia supplies software engineering students, IT professionals, researchers, managers, and scholars with unrivaled coverage of the topics that encompass this ever-changing field. Also Available Online This Taylor & Francis encyclopedia is also available through online subscription, offering a variety of extra benefits for researchers, students, and librarians, including: Citation tracking and alerts Active reference linking Saved searches and marked lists HTML and PDF format options Contact Taylor and Francis for more information or to inquire about subscription options and print/online combination packages. US: (Tel) 1.888.318.2367; (E-mail) [email protected] International: (Tel) +44 (0) 20 7017 6062; (E-mail) [email protected]

5 bookseller s catalogues

5 bookseller s catalogues
Author: Edward Howell (bookseller.)
Publsiher: Unknown
Total Pages: 135
Release: 1867
ISBN: 1928374650XXX
Category: Electronic Book
Language: EN, FR, DE, ES & NL

5 bookseller s catalogues Book Excerpt:

Practical Approaches to Method Validation and Essential Instrument Qualification

Practical Approaches to Method Validation and Essential Instrument Qualification
Author: Chung Chow Chan,Herman Lam,Xue-Ming Zhang
Publsiher: John Wiley & Sons
Total Pages: 416
Release: 2011-03-01
ISBN: 1118060318
Category: Science
Language: EN, FR, DE, ES & NL

Practical Approaches to Method Validation and Essential Instrument Qualification Book Excerpt:

Practical approaches to ensure that analytical methods and instruments meet GMP standards and requirements Complementing the authors' first book, Analytical Method Validation and Instrument Performance Verification, this new volume provides coverage of more advanced topics, focusing on additional and supplemental methods, instruments, and electronic systems that are used in pharmaceutical, biopharmaceutical, and clinical testing. Readers will gain new and valuable insights that enable them to avoid common pitfalls in order to seamlessly conduct analytical method validation as well as instrument operation qualification and performance verification. Part 1, Method Validation, begins with an overview of the book's risk-based approach to phase appropriate validation and instrument qualification; it then focuses on the strategies and requirements for early phase drug development, including validation of specific techniques and functions such as process analytical technology, cleaning validation, and validation of laboratory information management systems Part 2, Instrument Performance Verification, explores the underlying principles and techniques for verifying instrument performance—coverage includes analytical instruments that are increasingly important to the pharmaceutical industry, such as NIR spectrometers and particle size analyzers—and offers readers a variety of alternative approaches for the successful verification of instrument performance based on the needs of their labs At the end of each chapter, the authors examine important practical problems and share their solutions. All the methods covered in this book follow Good Analytical Practices (GAP) to ensure that reliable data are generated in compliance with current Good Manufacturing Practices (cGMP). Analysts, scientists, engineers, technologists, and technical managers should turn to this book to ensure that analytical methods and instruments are accurate and meet GMP standards and requirements.

Handbook of LC MS Bioanalysis

Handbook of LC MS Bioanalysis
Author: Wenkui Li,Jie Zhang,Francis L. S. Tse
Publsiher: John Wiley & Sons
Total Pages: 704
Release: 2013-09-03
ISBN: 111867135X
Category: Science
Language: EN, FR, DE, ES & NL

Handbook of LC MS Bioanalysis Book Excerpt:

Consolidates the information LC-MS bioanalytical scientistsneed to analyze small molecules and macromolecules The field of bioanalysis has advanced rapidly, propelled by newapproaches for developing bioanalytical methods, new liquidchromatographic (LC) techniques, and new mass spectrometric (MS)instruments. Moreover, there are a host of guidelines andregulations designed to ensure the quality of bioanalyticalresults. Presenting the best practices, experimental protocols, and thelatest understanding of regulations, this book offers acomprehensive review of LC-MS bioanalysis of small molecules andmacromolecules. It not only addresses the needs of bioanalyticalscientists working on routine projects, but also explores advancedand emerging technologies such as high-resolution mass spectrometryand dried blood spot microsampling. Handbook of LC-MS Bioanalysis features contributions froman international team of leading bioanalytical scientists. Theircontributions reflect a review of the latest findings, practices,and regulations as well as their own firsthand analyticallaboratory experience. The book thoroughly examines: Fundamentals of LC-MS bioanalysis in drug discovery, drugdevelopment, and therapeutic drug monitoring The current understanding of regulations governing LC-MSbioanalysis Best practices and detailed technical instructions for LC-MSbioanalysis method development, validation, and stabilityassessment of analyte(s) of interest Experimental guidelines and protocols for quantitative LC-MSbioanalysis of challenging molecules, including pro-drugs, acylglucuronides, N-oxides, reactive compounds, and photosensitive andautooxidative compounds With its focus on current bioanalytical practice, Handbook ofLC-MS Bioanalysis enables bioanalytical scientists to developand validate robust LC-MS assay methods, all in compliance withcurrent regulations and standards.

Industrial Metrology for Medical Products and Devices

Industrial Metrology for Medical Products and Devices
Author: Robert Roithmeier
Publsiher: Carl Zeiss AG
Total Pages: 135
Release: 2020-03-24
ISBN: 1928374650XXX
Category: Technology & Engineering
Language: EN, FR, DE, ES & NL

Industrial Metrology for Medical Products and Devices Book Excerpt:

Medical progress is associated with innovative product developments in medical technology, e.g. for different implants and instruments. The developments are also characterized by increasing miniaturization and precision. Hence the demands on the geometric and surface characteristics of the usually complex form elements are growing. Consequently, the need for highly-accurate dimensional inspection for the verification of these characteristics is rapidly increasing. ZEISS successfully and reliably faces these challenges. Being a leading manufacturer of medical technology as well as of measurement and inspection technology, the company ZEISS has a high level of know-how in the industrial production of medical devices and products. This book presents the metrological solutions for the medical technology and explains their application. The required measuring machines and the task-based sensors are addressed to the same extent as the challenges regarding automated 100 % checks. Methods for checking the reliability of measuring results and evaluating the inspection process quality are presented and the required procedures are described in detail. The extended regulations for medical devices and products, e.g. by FDA and MDR, place high demands on the measurement technology used and on the electronic documentation of measurement results. This is addressed in detail at the end of the book; in the appendix, easy-to-use checklists for the regulations according to 21 CFR Part 11 are provided.

Racing Calendar

Racing Calendar
Author: Anonim
Publsiher: Unknown
Total Pages: 135
Release: 1875
ISBN: 1928374650XXX
Category: Horse racing
Language: EN, FR, DE, ES & NL

Racing Calendar Book Excerpt:

Works

Works
Author: Charles Dickens
Publsiher: Unknown
Total Pages: 508
Release: 1869
ISBN: 1928374650XXX
Category: Electronic Book
Language: EN, FR, DE, ES & NL

Works Book Excerpt:

Supply Chain Management in the Drug Industry

Supply Chain Management in the Drug Industry
Author: Hedley Rees
Publsiher: John Wiley & Sons
Total Pages: 448
Release: 2011-04-06
ISBN: 0470922842
Category: Medical
Language: EN, FR, DE, ES & NL

Supply Chain Management in the Drug Industry Book Excerpt:

This book bridges the gap between practitioners of supply-chain management and pharmaceutical industry experts. It aims to help both these groups understand the different worlds they live in and how to jointly contribute to meaningful improvements in supply-chains within the globally important pharmaceutical sector. Scientific and technical staff must work closely with supply-chain practitioners and other relevant parties to help secure responsive, cost effective and risk mitigated supply chains to compete on a world stage. This should not wait until a drug has been registered, but should start as early as possible in the development process and before registration or clinical trials. The author suggests that CMC (chemistry manufacturing controls) drug development must reset the line of sight – from supply of drug to the clinic and gaining a registration, to the building of a patient value stream. Capable processes and suppliers, streamlined logistics, flexible plant and equipment, shorter cycle times, effective flow of information and reduced waste. All these factors can and should be addressed at the CMC development stage.

The Readings of Mr Charles Dickens as Condensed by Himself

The Readings of Mr  Charles Dickens  as Condensed by Himself
Author: Charles Dickens
Publsiher: Unknown
Total Pages: 410
Release: 1868
ISBN: 1928374650XXX
Category: Electronic Book
Language: EN, FR, DE, ES & NL

The Readings of Mr Charles Dickens as Condensed by Himself Book Excerpt:

The Readings of Charles Dickens

The Readings of Charles Dickens
Author: Charles Dickens
Publsiher: Unknown
Total Pages: 135
Release: 1867
ISBN: 1928374650XXX
Category: Electronic Book
Language: EN, FR, DE, ES & NL

The Readings of Charles Dickens Book Excerpt: