Data Integrity in Pharmaceutical and Medical Devices Regulation Operations

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Author :
Publisher : CRC Press
ISBN 13 : 1315349973
Total Pages : 268 pages
Book Rating : 4.3/5 (153 download)

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Book Synopsis Data Integrity in Pharmaceutical and Medical Devices Regulation Operations by : Orlando Lopez

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.

Looking Back to Change Track

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Author :
Publisher : The Energy and Resources Institute (TERI)
ISBN 13 : 9788179931042
Total Pages : 196 pages
Book Rating : 4.9/5 (31 download)

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Book Synopsis Looking Back to Change Track by :

Download or read book Looking Back to Change Track written by and published by The Energy and Resources Institute (TERI). This book was released on 2007-01-01 with total page 196 pages. Available in PDF, EPUB and Kindle. Book excerpt: Looking back to change track provides an answer to the questions that have marked the country's efforts to manage air pollution, water stress, waste disposal, forest wealth, and it's rich storehouses of biodiversity. In 1997, when India celebrated the 50th anniversary of its Independence, TERI's assessment of trends in the state of the environment in these 50 years sounded an alarm over the rapid deterioration of the nation's natural resources. 1997 was also a year when the fruits of economic liberalization were beginning to be realized, but what seemed to have slipped past policy-makers and the public alike was the pressure increased economic growth was exerting on India's natural resources. TERI estimated that the economic costs of environmental degradation in India already exceeded 10% of the country's gross domestic product. Released as GREEN India 2047, TERI's findings made it amply clear that neglecting the state of India's environment in the quest for development was an unsustainable proposition. The title explains that while in some cases, irreparable loss to the environment has occurred, in others, there still remains time to halt, reverse, and minimize the damage. As we step further into the 21st century, new approaches and strategies are required to tackle the onslaught faced by our vulnerable environment. This publication articulates some of these, which include progressive policy-making, sustained public'private partnerships, increased support for research and development of sustainable technologies, and last but definitely not the least, greater mobilization by civil society to protect India's natural resources. The message inherent in this book is that the stakeholders of India's natural resources include no one else but us Indians, and we need to partner each other to bring about a change in the way our environment is managed. For inspiration, we need to go no further than the Father of the Nation himself, whose advice ?Be the change you want to see in the world ? is as relevant to our relationship with our environment as in any other context.

Implantable Electronic Medical Devices

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Author :
Publisher : Elsevier
ISBN 13 : 012416577X
Total Pages : 194 pages
Book Rating : 4.1/5 (241 download)

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Book Synopsis Implantable Electronic Medical Devices by : Dennis Fitzpatrick

Download or read book Implantable Electronic Medical Devices written by Dennis Fitzpatrick and published by Elsevier. This book was released on 2014-11-05 with total page 194 pages. Available in PDF, EPUB and Kindle. Book excerpt: Implantable Electronic Medical Devices provides a thorough review of the application of implantable devices, illustrating the techniques currently being used together with overviews of the latest commercially available medical devices. This book provides an overview of the design of medical devices and is a reference on existing medical devices. The book groups devices with similar functionality into distinct chapters, looking at the latest design ideas and techniques in each area, including retinal implants, glucose biosensors, cochlear implants, pacemakers, electrical stimulation therapy devices, and much more. Implantable Electronic Medical Devices equips the reader with essential background knowledge on the application of existing medical devices as well as providing an introduction to the latest techniques being used. - A catalogue of existing implantable electronic medical devices - Up-to-date information on the design of implantable electronic medical devices - Background information and reviews on the application and design of up-to-date implantable electronic medical devices

Materials for Advanced Packaging

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Author :
Publisher : Springer
ISBN 13 : 3319450980
Total Pages : 974 pages
Book Rating : 4.3/5 (194 download)

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Book Synopsis Materials for Advanced Packaging by : Daniel Lu

Download or read book Materials for Advanced Packaging written by Daniel Lu and published by Springer. This book was released on 2016-11-18 with total page 974 pages. Available in PDF, EPUB and Kindle. Book excerpt: Significant progress has been made in advanced packaging in recent years. Several new packaging techniques have been developed and new packaging materials have been introduced. This book provides a comprehensive overview of the recent developments in this industry, particularly in the areas of microelectronics, optoelectronics, digital health, and bio-medical applications. The book discusses established techniques, as well as emerging technologies, in order to provide readers with the most up-to-date developments in advanced packaging.

Technological Change and Manpower Trends in Six Industries ..

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Publisher :
ISBN 13 :
Total Pages : 488 pages
Book Rating : 4.3/5 (243 download)

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Book Synopsis Technological Change and Manpower Trends in Six Industries .. by : United States. Bureau of Labor Statistics

Download or read book Technological Change and Manpower Trends in Six Industries .. written by United States. Bureau of Labor Statistics and published by . This book was released on 1974 with total page 488 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Public Health Reports

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Publisher :
ISBN 13 :
Total Pages : 752 pages
Book Rating : 4.3/5 (555 download)

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Book Synopsis Public Health Reports by :

Download or read book Public Health Reports written by and published by . This book was released on 2005 with total page 752 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Health Services Reports

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Author :
Publisher :
ISBN 13 :
Total Pages : 864 pages
Book Rating : 4.:/5 (31 download)

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Book Synopsis Health Services Reports by :

Download or read book Health Services Reports written by and published by . This book was released on 2005 with total page 864 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Engineering News

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Author :
Publisher :
ISBN 13 :
Total Pages : 758 pages
Book Rating : 4.:/5 ( download)

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Book Synopsis Engineering News by :

Download or read book Engineering News written by and published by . This book was released on 1906 with total page 758 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Registries for Evaluating Patient Outcomes

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Author :
Publisher : Government Printing Office
ISBN 13 : 1587634333
Total Pages : 385 pages
Book Rating : 4.5/5 (876 download)

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Book Synopsis Registries for Evaluating Patient Outcomes by : Agency for Healthcare Research and Quality/AHRQ

Download or read book Registries for Evaluating Patient Outcomes written by Agency for Healthcare Research and Quality/AHRQ and published by Government Printing Office. This book was released on 2014-04-01 with total page 385 pages. Available in PDF, EPUB and Kindle. Book excerpt: This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.

Mandatory Health and Safety Standards

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Publisher :
ISBN 13 :
Total Pages : 160 pages
Book Rating : 4.:/5 (3 download)

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Book Synopsis Mandatory Health and Safety Standards by : United States. Mining Enforcement and Safety Administration

Download or read book Mandatory Health and Safety Standards written by United States. Mining Enforcement and Safety Administration and published by . This book was released on 1973 with total page 160 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Oxford Desk Reference: Critical Care

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Author :
Publisher : OUP Oxford
ISBN 13 : 0191551996
Total Pages : 632 pages
Book Rating : 4.1/5 (915 download)

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Book Synopsis Oxford Desk Reference: Critical Care by : Carl Waldmann

Download or read book Oxford Desk Reference: Critical Care written by Carl Waldmann and published by OUP Oxford. This book was released on 2008-11-27 with total page 632 pages. Available in PDF, EPUB and Kindle. Book excerpt: Critical care medicine is an evolving speciality in which the amount of available information is growing daily and spread across a myriad of books, journals and websites. This essential guide brings together this information in an easy-to-use format. Up-to-date, relevant, and evidence-based information on the management of the critically ill is combined in one resource, ideal for the use of Intensive Care Units, High Dependency Units, acute medical or surgical wards, Accident and Emergency departments and operating theatres. The book is designed such that each subject will form a self-contained topic in its own right, laid out across two or four pages to facilitate the key aim of rapid and easy access to information. This makes the information included simple to find, read and absorb, so that the book can be consulted in the clinic or ward setting for information on the optimum management of a particular condition. With chapters written by internationally renowned critical care specialists and edited by the three of the leading figures in UK Critical Care, this book should be an essential resource for all critical care physicians.

Engineering News and American Contract Journal

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Author :
Publisher :
ISBN 13 :
Total Pages : 1010 pages
Book Rating : 4.:/5 (31 download)

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Book Synopsis Engineering News and American Contract Journal by :

Download or read book Engineering News and American Contract Journal written by and published by . This book was released on 1906 with total page 1010 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Facilities Manager's Desk Reference

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Publisher : John Wiley & Sons
ISBN 13 : 1119633591
Total Pages : 708 pages
Book Rating : 4.1/5 (196 download)

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Book Synopsis Facilities Manager's Desk Reference by : Jane M. Wiggins

Download or read book Facilities Manager's Desk Reference written by Jane M. Wiggins and published by John Wiley & Sons. This book was released on 2020-12-14 with total page 708 pages. Available in PDF, EPUB and Kindle. Book excerpt: A practical guide to the principle services of facilities management, revised and updated The updated third edition of Facilities Manager's Desk Reference is an invaluable resource covering all the principal facility management (FM) services. The author—a noted facilities management expert—provides the information needed to ensure compliance to current laws, to deliver opportunities to adopt new ways of using built environments, and to identify creative ways to reduce operational occupancy costs, while maintaining appropriate and productive working environment standards. The third edition is fully updated and written in an approachable and concise format. It is comprehensive in scope, the author covering both hard and soft facilities management issues. Since the first edition was published it has become a first point of reference for busy facilities managers, saving them time by providing access to the information needed to ensure the safe, effective and efficient running of any facilities function. This important book: Has been fully updated, reviewing the essential data covering the principal FM services Is highly practical, ideal for the busy FM practitioner Presents information on legal compliance issues, the development of strategic policies, tactical best practices, and much more Is a time-saving resource that brings together essential, useful, and practical FM information in one handy volume; Written for students and professional facilities managers, Facilities Manager's Desk Reference is designed as a practical resource that offers FMs assistance in finding solutions to the myriad demands of the job.

ICT Futures

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Publisher : John Wiley & Sons
ISBN 13 : 9780470758663
Total Pages : 268 pages
Book Rating : 4.7/5 (586 download)

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Book Synopsis ICT Futures by : Paul Warren

Download or read book ICT Futures written by Paul Warren and published by John Wiley & Sons. This book was released on 2008-04-30 with total page 268 pages. Available in PDF, EPUB and Kindle. Book excerpt: Learn all about the major trends and future advancements in ICT! ICT Futures provides an insightful introduction to the major technology trends in Information and Communication Technologies (ICT), and to the economic, commercial and societal environment which is shaping them. The experienced author-team, consisting of experts from both industry and academia, addresses: The interaction between people and technology - how ICT affects every day social practices; the rise of social computing; how the way we interact with information and the devices we use are changing; and how trust can be assured over the Internet. The underlying ICT infrastructure - the semantic web and the semantic intranet; the real-time service-oriented infrastructure; the future optical network; self-managing networks and agents; P2P technologies; pervasiveness; mobility and wireless technology; and how all this infrastructure can be made secure. ICT technology and how it is affecting industries as diverse as health, finance, retail and law. The book covers a vast wealth of material, with a strong focus upon the impending changes to the way ICT operates.This reference is a valuable tool for people in managerial roles, CIOs, CTOs, business and technology strategists, and students undertaking technology MBAs, or technology modules in general MBAs. Professionals working in ICT will also find this book valuable.

Medical Affairs

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Publisher : CRC Press
ISBN 13 : 1003834019
Total Pages : 267 pages
Book Rating : 4.0/5 (38 download)

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Book Synopsis Medical Affairs by : Kirk V. Shepard

Download or read book Medical Affairs written by Kirk V. Shepard and published by CRC Press. This book was released on 2024-01-30 with total page 267 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical Affairs is one of the three strategic pillars of the pharmaceutical and MedTech industries, but while clear career paths exist for Commercial and Research and Development, there is no formal training structure for Medical Affairs professionals. Medical and scientific expertise is a prerequisite for entry into the function, and many people transitioning into Medical Affairs have advanced degrees such as PhD, MD, or PharmD. However, these clinical/scientific experts may not be especially well-versed in aspects of industry such as the drug development lifecycle, crossfunctional collaborations within industry, and digital tools that are transforming the ways Medical Affairs generates and disseminates knowledge. This primer for aspiring and early-career Medical Affairs professionals equips readers with the baseline skills and understanding to excel across roles. Features: Defines the purpose and value of Medical Affairs and provides clear career paths for scientific experts seeking their place within the pharmaceutical and MedTech industries. Provides guidance and baseline competencies for roles within Medical Affairs including Medical Communications, Evidence Generation, Field Medical, Compliance, and many others. Specifies the "true north" of the Medical Affairs profession as ensuring patients receive maximum benefit from industry innovations including drugs, diagnostics and devices. Presents the purpose and specific roles of Medical Affairs roles across organization types including biotechs, small/medium/large pharma and device/diagnostic companies, taking into account adjustments in the practice of Medical Affairs to meet the needs of developing fields such as rare disease and gene therapy. Leverages the expertise of over 60 Medical Affairs leaders across companies, representing the first unified, global understanding of the Medical Affairs profession.

Ensuring the Integrity of Electronic Health Records

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Author :
Publisher : CRC Press
ISBN 13 : 1000223035
Total Pages : 203 pages
Book Rating : 4.0/5 (2 download)

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Book Synopsis Ensuring the Integrity of Electronic Health Records by : Orlando López

Download or read book Ensuring the Integrity of Electronic Health Records written by Orlando López and published by CRC Press. This book was released on 2020-12-21 with total page 203 pages. Available in PDF, EPUB and Kindle. Book excerpt: Data integrity is a critical aspect to the design, implementation, and usage of any system which stores, processes, or retrieves data. The overall intent of any data integrity technique is the same: ensure data is recorded exactly as intended and, upon later retrieval, ensure the data is the same as it was when originally recorded. Any alternation to the data is then traced to the person who made the modification. The integrity of data in a patient’s electronic health record is critical to ensuring the safety of the patient. This book is relevant to production systems and quality control systems associated with the manufacture of pharmaceuticals and medical device products and updates the practical information to enable better understanding of the controls applicable to e-records. The book highlights the e-records suitability implementation and associated risk-assessed controls, and e-records handling. The book also provides updated regulatory standards from global regulatory organizations such as MHRA, Medicines and Healthcare Products Regulatory Agency (UK); FDA, Food and Drug Administration (US); National Medical Products Association (China); TGA, Therapeutic Goods Administration (Australia); SIMGP, Russia State Institute of Medicines and Good Practices; and the World Health Organization, to name a few.

Human-Machine Interface

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Author :
Publisher : John Wiley & Sons
ISBN 13 : 1394199910
Total Pages : 532 pages
Book Rating : 4.3/5 (941 download)

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Book Synopsis Human-Machine Interface by : Rishabha Malviya

Download or read book Human-Machine Interface written by Rishabha Malviya and published by John Wiley & Sons. This book was released on 2023-11-21 with total page 532 pages. Available in PDF, EPUB and Kindle. Book excerpt: HUMAN-MACHINE INTERFACE The book contains the latest advances in healthcare and presents them in the frame of the Human-Machine Interface (HMI). The Human-Machine Interface (HMI) industry has witnessed the evolution from a simple push button to a modern touch-screen display. HMI is a user interface that allows humans to operate controllers for machines, systems, or instruments. Most medical procedures are improved by HMI systems, from calling an ambulance to ensuring that a patient receives adequate treatment on time. This book describes the scenario of biomedical technologies in the context of the advanced HMI, with a focus on direct brain-computer connection. The book describes several HMI tools and related techniques for analyzing, creating, controlling, and upgrading healthcare delivery systems, and provides details regarding how advancements in technology, particularly HMI, ensure ethical and fair use in patient care. Audience The target audience for this book is medical personnel and policymakers in healthcare and pharmaceutical professionals, as well as engineers and researchers in computer science and artificial intelligence.