Download or read book Part 11 and Computer Validation Manual and CD written by Daniel Farb and published by University of Health Care. This book was released on 2003-12 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is a package of Agent GXP FDA Part 11 and Pharmaceutica Computer Validation Introduction. These two related courses will give the learner an excellent introduction to computer isues in the pharmaceutical industry. This course will teach you the history, applications, regulations, implementation, ideas and how to prepare Part 11.
Download or read book Part 11 and Computer Validation written by Daniel Farb, M. D. and published by Universityofhealthcare. This book was released on 2004-06-01 with total page 224 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is a package of Agent GXP FDA Part 11 and Pharmaceutical Computer Validation Introduction. These two related courses will give the learner an excellent introduction to computer issues in the pharmaceutical industry. Agent GXP FDA Part 11 teaches the FDA regulations on electronic signatures and records in the context of a spoof on a hostage rescue supervised by Pharm Mission Control. It is taught mostly through interactive questions and interviews with Agent GXP. The many difficult regulations of Part 11 are broken down into episodes that make the learning more memorable. This thorough course will teach you the history of Part 11, the regulations of Part 11, the implementation of Part 11, the applications of Part 11, the ideas behind Part 11 in order to apply them to new situations, and how to prepare for enforcement of Part 11. This is particularly important for both pharmaceutical/medical device manufacturing and clinical research personnel in FDA-regulated industries, and provides an excellent glimpse of the issues that are likely to face HIPAA implementation of electronic records security measures. This course has been used by thousands of people in the pharmaceutical industry. When you successfully complete the exam, you will receive a certificate of completion that will demonstrate your mastery of this topic and provide documentation of GMP training. Estimated time: 3-6 hours. Pharmaceutical Computer Validation Introduction gives you a comprehensive introduction to computer systems validation as the computers come to life while the head of computer systems at a pharmaceutical company has to prepare for an FDA inspection. You will learn about regulations, the personnel responsible for computer validation, how to accomplish validation, examples of regulatory problems, and so on. It is also relevant for the medical device, food, and cosmetic industries. When you successfully complete the exam, you will receive a certificate of completion to document your training for the FDA or for employers. Estimated time: 2-3 hours. Both courses are 402 pages on CD. 224 pages in the manual include handy printouts of many relevant FDA regulations. The manual accompanying the CD provides a summary of the major points of the CD in a handy format. You must have Internet Explorer 4.0 or higher running on your computer. Supported operating systems are Windows 95, 98, 98 SE, ME, 2000, or XP. The CD is licensed to play once on any Windows computer; the borrower may purchase the program after that. One library reference activation is included in the price.
Download or read book Part 11 and Computer Validation Guidebook written by Daniel Farb and published by UniversityOfHealthCare. This book was released on 2005 with total page 329 pages. Available in PDF, EPUB and Kindle. Book excerpt: Gives an introduction to computer issues in the pharmaceutical industry, as well as to computer systems validation. This work helps you learn about regulations, the personnel responsible for computer validation, how to accomplish validation, examples of regulatory problems, and more. It is useful for research personnel in FDA-regulated industries.
Download or read book Pharmaceutical Computer Validation Introduction written by Daniel Farb and published by Universityofhealthcare. This book was released on 2003-12-01 with total page 86 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceutical Computer Validation Introduction gives you a comprehensive introduction to computer systems validation as the computers come to life while the head of computer systems at a pharmaceutical company has to prepare for an FDA inspection. You will learn about regulations, the personnel responsible for computer validation, how to accomplish validation, and so on.
Download or read book Validation of Chromatography Data Systems written by Robert McDowall and published by Royal Society of Chemistry. This book was released on 2007-10-31 with total page 289 pages. Available in PDF, EPUB and Kindle. 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.
Download or read book Practical Guide to Clinical Data Management Third Edition written by Susanne Prokscha and published by CRC Press. This book was released on 2011-10-26 with total page 298 pages. Available in PDF, EPUB and Kindle. Book excerpt: The management of clinical data, from its collection during a trial to its extraction for analysis, has become a critical element in the steps to prepare a regulatory submission and to obtain approval to market a treatment. Groundbreaking on its initial publication nearly fourteen years ago, and evolving with the field in each iteration since then, the third edition of Practical Guide to Clinical Data Management includes important updates to all chapters to reflect the current industry approach to using electronic data capture (EDC) for most studies. See what’s new in the Third Edition: A chapter on the clinical trial process that explains the high level flow of a clinical trial from creation of the protocol through the study lock and provides the context for the clinical data management activities that follow Reorganized content reflects an industry trend that divides training and standard operating procedures for clinical data management into the categories of study startup, study conduct, and study closeout Coverage of current industry and Food and Drug Administration (FDA) approaches and concerns The book provides a comprehensive overview of the tasks involved in clinical data management and the computer systems used to perform those tasks. It also details the context of regulations that guide how those systems are used and how those regulations are applied to their installation and maintenance. Keeping the coverage practical rather than academic, the author hones in on the most critical information that impacts clinical trial conduct, providing a full end-to-end overview or introduction for clinical data managers.
Download or read book Validation of Chromatography Data Systems written by Robert D. McDowall and published by Royal Society of Chemistry. This book was released on 2016-11-25 with total page 778 pages. Available in PDF, EPUB and Kindle. 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.
Download or read book GMP Training Package Manual and CD written by Daniel Farb, M.D. and published by Universityofhealthcare. This book was released on 2003-12-01 with total page 258 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Data Integrity in Pharmaceutical and Medical Devices Regulation Operations written by Orlando Lopez and published by CRC Press. This book was released on 2016-11-03 with total page 268 pages. Available in PDF, EPUB and Kindle. Book excerpt: Data integrity is fundamental in a pharmaceutical and medical devices quality system. This book provides practical information to enable compliance with data integrity, while highlighting and efficiently integrating worldwide regulation into the subject. The ideas presented in this book are based on many years’ experience in regulated industries in various computer systems development, maintenance, and quality functions. In addition to case studies, a practical approach will be presented to increase efficiency and to ensure that the design and testing of the data integrity controls are correctly achieved.
Download or read book Concurrent Design of Products Manufacturing Processes and Systems written by Ben Wang and published by CRC Press. This book was released on 1999-01-27 with total page 390 pages. Available in PDF, EPUB and Kindle. Book excerpt: Methods presented involve the use of simulation and modeling tools and virtual workstations in conjunction with a design environment. This allows a diverse group of researchers, manufacturers, and suppliers to work within a comprehensive network of shared knowledge. The design environment consists of engineering workstations and servers and a suite of simulation, quantitative, computational, analytical, qualitative and experimental tools. Such a design environment will allow the effective and efficient integration of complete product design, manufacturing process design, and customer satisfaction predictions. This volume enables the reader to create an integrated concurrent engineering design and analysis infrastructure through the use of virtual workstations and servers; provide remote, instant sharing of engineering data and resources for the development of a product, system, mechanism, part, business and/or process, and develop applications fully compatible with international CAD/CAM/CAE standards for product representation and modeling.
Download or read book Validation of Pharmaceutical Processes written by James P. Agalloco and published by CRC Press. This book was released on 2007-09-25 with total page 762 pages. Available in PDF, EPUB and Kindle. Book excerpt: Completely revised and updated to reflect the significant advances in pharmaceutical production and regulatory expectations, this third edition of Validation of Pharmaceutical Processes examines and blueprints every step of the validation process needed to remain compliant and competitive. The many chapters added to the prior compilation examine va
Download or read book Leveraging Applications of Formal Methods Verification and Validation Software Engineering written by Tiziana Margaria and published by Springer Nature. This book was released on 2022-10-19 with total page 437 pages. Available in PDF, EPUB and Kindle. Book excerpt: This four-volume set LNCS 13701-13704 constitutes contributions of the associated events held at the 11th International Symposium on Leveraging Applications of Formal Methods, ISoLA 2022, which took place in Rhodes, Greece, in October/November 2022. The contributions in the four-volume set are organized according to the following topical sections: specify this - bridging gaps between program specification paradigms; x-by-construction meets runtime verification; verification and validation of concurrent and distributed heterogeneous systems; programming - what is next: the role of documentation; automated software re-engineering; DIME day; rigorous engineering of collective adaptive systems; formal methods meet machine learning; digital twin engineering; digital thread in smart manufacturing; formal methods for distributed computing in future railway systems; industrial day.
Download or read book GAMP Good Practice Guide written by and published by Ispe Headquarters. This book was released on 2005-01-01 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Technical Information Indexes written by and published by . This book was released on 1975 with total page 126 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book System Level Hardware Software Co Design written by Joris van den Hurk and published by Springer Science & Business Media. This book was released on 1997-12-31 with total page 252 pages. Available in PDF, EPUB and Kindle. Book excerpt: Hierarchical design methods were originally introduced for the design of digital ICs, and they appeared to provide for significant advances in design productivity, Time-to-Market, and first-time right design. These concepts have gained increasing importance in the semiconductor industry in recent years. In the course of time, the supportive quality of hierarchical methods and their advantages were confirmed. System Level Hardware/Software Co-design: An Industrial Approach demonstrates the applicability of hierarchical methods to hardware / software codesign, and mixed analogue / digital design following a similar approach. Hierarchical design methods provide for high levels of design support, both in a qualitative and a quantitative sense. In the qualitative sense, the presented methods support all phases in the product life cycle of electronic products, ranging from requirements analysis to application support. Hierarchical methods furthermore allow for efficient digital hardware design, hardware / software codesign, and mixed analogue / digital design, on the basis of commercially available formalisms and design tools. In the quantitative sense, hierarchical methods have prompted a substantial increase in design productivity. System Level Hardware/Software Co-design: An Industrial Approach reports on a six year study during which time the number of square millimeters of normalized complexity an individual designer contributed every week rose by more than a factor of five. Hierarchical methods therefore enabled designers to keep track of the ever increasing design complexity, while effectively reducing the number of design iterations in the form of redesigns. System Level Hardware/Software Co-design: An Industrial Approach is the first book to provide a comprehensive, coherent system design methodology that has been proven to increase productivity in industrial practice. The book will be of interest to all managers, designers and researchers working in the semiconductor industry.
Download or read book Fundamentals of Clinical Data Science written by Pieter Kubben and published by Springer. This book was released on 2018-12-21 with total page 219 pages. Available in PDF, EPUB and Kindle. Book excerpt: This open access book comprehensively covers the fundamentals of clinical data science, focusing on data collection, modelling and clinical applications. Topics covered in the first section on data collection include: data sources, data at scale (big data), data stewardship (FAIR data) and related privacy concerns. Aspects of predictive modelling using techniques such as classification, regression or clustering, and prediction model validation will be covered in the second section. The third section covers aspects of (mobile) clinical decision support systems, operational excellence and value-based healthcare. Fundamentals of Clinical Data Science is an essential resource for healthcare professionals and IT consultants intending to develop and refine their skills in personalized medicine, using solutions based on large datasets from electronic health records or telemonitoring programmes. The book’s promise is “no math, no code”and will explain the topics in a style that is optimized for a healthcare audience.
Download or read book Electrical Power Systems and Computers written by Xiaofeng Wan and published by Springer Science & Business Media. This book was released on 2011-06-21 with total page 1005 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume includes extended and revised versions of a set of selected papers from the International Conference on Electric and Electronics (EEIC 2011) , held on June 20-22 , 2011, which is jointly organized by Nanchang University, Springer, and IEEE IAS Nanchang Chapter. The objective of EEIC 2011 Volume 3 is to provide a major interdisciplinary forum for the presentation of new approaches from Electrical Power Systems and Computers, to foster integration of the latest developments in scientific research. 133 related topic papers were selected into this volume. All the papers were reviewed by 2 program committee members and selected by the volume editor Prof. Xiaofeng Wan. We hope every participant can have a good opportunity to exchange their research ideas and results and to discuss the state of the art in the areas of the Electrical Power Systems and Computers.
