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Medical Device Quality Assurance and Regulatory Compliance by Richard C. Fries Pdf
"Acquaints developers of medical devices with the basic concepts and major issues of medical quality assurance and regulatory documents, describes the requirements listed in these documents, and provides strategies for compliance with these requirements."
Medical Device Quality Assurance and Regulatory Compliance by Richard C. Fries Pdf
"Acquaints developers of medical devices with the basic concepts and major issues of medical quality assurance and regulatory documents, describes the requirements listed in these documents, and provides strategies for compliance with these requirements."
This essential guide has now been fully revised and expanded to take into account the revision of ISO 9001 in 1994. The second edition also addresses the increasing demands, requirements and controls of information transfer, an activity which today is having a great impact on the success of engineering projects. The ISO 9000 series of standards is a formalized quality assurance management system designed to ensure that quality is built into every stage of the activity in hand. Wider application of the same principles across every aspect of a company's activities leads to Total Quality Management. The guidance given is intended to help contracting and operating companies in the chemical process industries, as well as those in the food, drink, pharmaceutical and building industries, as they strive for greater quality and to comply with ever-stricter legislation on safety and the environment.
Pharmaceutical Computer Systems Validation by Guy Wingate Pdf
Thoroughly revised to include the latest industry developments, the Second Edition presents a comprehensive overview of computer validation and verification principles and how to put them into practice. To provide the current best practice and guidance on identifying and implementing improvements for computer systems, the text extensively reviews regulations of pharmaceuticals, healthcare products, blood processing, medical devices, clinical systems, and biotechnology. Ensuring that organizations transition smoothly to the new system, this guide explains how to implement the new GMP paradigm while maintaining continuity with current practices. In addition, all 24 case studies from the previous edition have been revised to reflect the new system.
ISO 9000 and Beyond by H. James Harringon,Dwayne D. Mathers Pdf
CD-ROM includes: Multimedia overview of book, including case studies -- High tech enablers examples -- Sample forms that support the quality management system -- Free workdraw process mapping software -- Web support database.
MDD Compliance Using Quality Management Techniques by Ray Tricker Pdf
The Medical Devices Directive (MDD) is an all-encompassing document legislating for the manufacture of any medical device or material used either temporarily or permanently on or in the human body. To achieve its main objectives the MDD requires the manufacturer of all products covered by the Directive to possess a fully auditable Quality Management System consisting of Quality Policies, Quality Procedures and Work Instructions, based on the ISO 9000 standard. The book is based on the sound principles of ISO 9000 and will guide to the reader, if required, to eventually set up an ISO 9000 fully compliant system. MDD-Compliance using Quality Management Techniques consists of the following: * A brief guide to the Medical Devices Directive - explaining the main requirements of the directive, translating legal "Eurospeak" into everyday language * An overview of ISO 9000 and how the MDD links in with these international requirements. * A Quality Manual - will provide a template for a complete Quality Management System that can be used by any product being produced under the requirements of the MDD * CD ROM containing a software copy of the Quality Manual * A User manual consisting of clear instructions and flow charts on how to set up and use the Quality Management System described in the Quality Manual
Both pervasive and ubiquitous, computerized systems are now an integral component of every corporate strategy in pharmaceutical and healthcare companies. However, when technology is combined with high-risk public safety projects or the production and control of life-saving medicines or devices, it is necessary to ensure that it is reliable, quality assured, and validated. The most comprehensive guide on computer validation currently available, containing more than 200 illustrations and more than 100 tables, Computer Systems Validation helps you see the big picture. The author reviews regulations and their development, organization responsibilities, validation life cycle based on GAMP4 Guide, strategic approaches to validation, electronic records and signatures, handling regulatory inspections, metrics, and opportunities for performance improvement. He presents practical examples and checklists throughout the book and explores the role of quality assurance and risk management as key components of pragmatic regulatory compliance. Covering methods that help you avoid duplicating effort among departments and business functions, the book demonstrates how you can use your investment in technology to improve business efficiency and gain the competitive edge.
Computer System Validation and GAMP 5 by Vonlynx Solutions LLC Pdf
The purpose of this book is to help you understand how computerized systems are validated using the GAMP5framework. The information will be presented in a project life cycle format. This will give you a solid idea howComputerized System Validation projects are conducted. This book is suited for anyone new to Computer SystemsValidation. It is written in a simple manner and can serve as starter guide which includes many high-level sample templates and illustration.
Handbook of Quality Assurance in Mental Health by Alex R. Rodriguez,Sharon A. Shueman Pdf
professional-standards-review organizations (PSRO) in defining quality of care for the Medicare program; it is a "shared responsibility of health professionals and government to provide a reasonable basis for confidence that action will be taken, both to assess whether services meet professionally recognized standards and to correct any deficiencies that may be found" (p. 14). Similar pronouncements have been made for the quality assurance activities of the Department of Defense's CHAMPUS program and of the 1980s successor to the PSROs, the federally designated peer-review organizations (PROs), established to ensure quality and utilization-efficient care for Medicare. Links between the federal and state gov ernments and between professional associations and private review entities have been developed to make this "shared responsibility" manifest in the delivery and reimbursement of health services. This responsibility is seen in light of both pro fessional and legal accountability, a view noted by Gibson and Singhas (1978) and Alger (1980). Accountability, then, becomes a concentric concept that elaborates on the pure view of quality and reflects the federal government's consumer protection activities during the 1970s. The Joint Commission on Accreditation of Hospitals (JCAH), which has pro vided another primary historical leadership role in defining quality assurance, has promoted the evolution of the concept of resource limitations as a part of the defini tion of quality assurance.
