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Quality Assurance Compliance
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Book Synopsis Medical Device Quality Assurance and Regulatory Compliance by : Richard C. Fries
Download or read book Medical Device Quality Assurance and Regulatory Compliance written by Richard C. Fries and published by CRC Press. This book was released on 1998-08-11 with total page 497 pages. Available in PDF, EPUB and Kindle. Book excerpt: "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."
Book Synopsis Pharmaceutical Computer Systems Validation by : Guy Wingate
Download or read book Pharmaceutical Computer Systems Validation written by Guy Wingate and published by CRC Press. This book was released on 2016-04-19 with total page 773 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Handbook of Software Quality Assurance by : G. Gordon Schulmeyer
Download or read book Handbook of Software Quality Assurance written by G. Gordon Schulmeyer and published by Artech House Publishers. This book was released on 2008 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Provides the latest details on current best practices and explains how SQA can be implemented in organizations large and small. Also helps readers understand the requirements of the ASQ's CSQE examination.
Author :Agency for Healthcare Research and Quality/AHRQ Publisher :Government Printing Office ISBN 13 :1587634333 Total Pages :385 pages Book Rating :4.5/5 (876 download)
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.
Book Synopsis Quality Assurance Project Plan for the Compliance Monitoring Program for Use and Operation of the Grassland Bypass Project by :
Download or read book Quality Assurance Project Plan for the Compliance Monitoring Program for Use and Operation of the Grassland Bypass Project written by and published by . This book was released on 2002 with total page 328 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Medical Device Quality Assurance and Regulatory Compliance by : Richard C. Fries
Download or read book Medical Device Quality Assurance and Regulatory Compliance written by Richard C. Fries and published by CRC Press. This book was released on 1998-08-11 with total page 504 pages. Available in PDF, EPUB and Kindle. Book excerpt: "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."
Book Synopsis Software Quality Assurance by : Ivan Mistrik
Download or read book Software Quality Assurance written by Ivan Mistrik and published by Morgan Kaufmann. This book was released on 2015-10-12 with total page 417 pages. Available in PDF, EPUB and Kindle. Book excerpt: Software Quality Assurance in Large Scale and Complex Software-intensive Systems presents novel and high-quality research related approaches that relate the quality of software architecture to system requirements, system architecture and enterprise-architecture, or software testing. Modern software has become complex and adaptable due to the emergence of globalization and new software technologies, devices and networks. These changes challenge both traditional software quality assurance techniques and software engineers to ensure software quality when building today (and tomorrow's) adaptive, context-sensitive, and highly diverse applications. This edited volume presents state of the art techniques, methodologies, tools, best practices and guidelines for software quality assurance and offers guidance for future software engineering research and practice. Each contributed chapter considers the practical application of the topic through case studies, experiments, empirical validation, or systematic comparisons with other approaches already in practice. Topics of interest include, but are not limited, to: quality attributes of system/software architectures; aligning enterprise, system, and software architecture from the point of view of total quality; design decisions and their influence on the quality of system/software architecture; methods and processes for evaluating architecture quality; quality assessment of legacy systems and third party applications; lessons learned and empirical validation of theories and frameworks on architectural quality; empirical validation and testing for assessing architecture quality. - Focused on quality assurance at all levels of software design and development - Covers domain-specific software quality assurance issues e.g. for cloud, mobile, security, context-sensitive, mash-up and autonomic systems - Explains likely trade-offs from design decisions in the context of complex software system engineering and quality assurance - Includes practical case studies of software quality assurance for complex, adaptive and context-critical systems
Book Synopsis Education Department General Administrative Regulations by : United States. Department of Education
Download or read book Education Department General Administrative Regulations written by United States. Department of Education and published by . This book was released on 1996 with total page 244 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Handbook of Quality Assurance in Mental Health by : Alex R. Rodriguez
Download or read book Handbook of Quality Assurance in Mental Health written by Alex R. Rodriguez and published by Springer Science & Business Media. This book was released on 2013-11-09 with total page 503 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Improving the Quality of Care in Nursing Homes by : Institute of Medicine
Download or read book Improving the Quality of Care in Nursing Homes written by Institute of Medicine and published by National Academies Press. This book was released on 1986-02-01 with total page 432 pages. Available in PDF, EPUB and Kindle. Book excerpt: As more people live longer, the need for quality long-term care for the elderly will increase dramatically. This volume examines the current system of nursing home regulations, and proposes an overhaul to better provide for those confined to such facilities. It determines the need for regulations, and concludes that the present regulatory system is inadequate, stating that what is needed is not more regulation, but better regulation. This long-anticipated study provides a wealth of useful background information, in-depth study, and discussion for nursing home administrators, students, and teachers in the health care field; professionals involved in caring for the elderly; and geriatric specialists.
Book Synopsis Pharmaceutical Microbiological Quality Assurance and Control by : David Roesti
Download or read book Pharmaceutical Microbiological Quality Assurance and Control written by David Roesti and published by John Wiley & Sons. This book was released on 2020-01-02 with total page 594 pages. Available in PDF, EPUB and Kindle. Book excerpt: Relying on practical examples from the authors’ experience, this book provides a thorough and modern approach to controlling and monitoring microbial contaminations during the manufacturing of non-sterile pharmaceuticals. Offers a comprehensive guidance for non-sterile pharmaceuticals microbiological QA/QC Presents the latest developments in both regulatory expectations and technical advancements Provides guidance on statistical tools for risk assessment and trending of microbiological data Describes strategy and practical examples from the authors’ experience in globalized pharmaceutical companies and expert networks Offers a comprehensive guidance for non-sterile pharmaceuticals microbiological QA/QC Presents the latest developments in both regulatory expectations and technical advancements Provides guidance on statistical tools for risk assessment and trending of microbiological data Describes strategy and practical examples from the authors’ experience in globalized pharmaceutical companies and expert networks
Author :Prof. Kakasaheb. J. Kore , Mr. P.S Minhas , Dr. Sudhahar Dharmalingam , Dr. Panikumar Durga Anumolu , Dr. Kella Alekhya Publisher :Shashwat Publication ISBN 13 :8119908562 Total Pages :257 pages Book Rating :4.1/5 (199 download)
Book Synopsis Quality Assurance: A Textbook by : Prof. Kakasaheb. J. Kore , Mr. P.S Minhas , Dr. Sudhahar Dharmalingam , Dr. Panikumar Durga Anumolu , Dr. Kella Alekhya
Download or read book Quality Assurance: A Textbook written by Prof. Kakasaheb. J. Kore , Mr. P.S Minhas , Dr. Sudhahar Dharmalingam , Dr. Panikumar Durga Anumolu , Dr. Kella Alekhya and published by Shashwat Publication. This book was released on 2024-05-16 with total page 257 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Pharmacy Council of India's (PCI) revised B. Pharmacy syllabus is followed in this state-of-the-art book. The broader topics of pharmaceutical quality assurance that undergrads, postgrads, industry professionals, researchers, and students getting ready for different competitive tests need to be covered in this book's encompassing content. The writing style of this book is clear, straightforward, and uncomplicated, which sets it apart from others. For the self-evlution of learning, the book is complemented by questions in the formats of multiple choice, fill in the blank, true-false, short answer, and long answer. Additionally included are the solutions to the True-False, Fill in the Blank, and Multiple Choice problems. Links to websites and recommended reading are provided to assist readers in staying up to date on the most recent advancements in the field of pharmaceutical quality assurance. The book can be used as the main source of instruction or as supplementary material by academicians and teachers at universities and colleges for undergraduate and graduate pharmacy courses.
Book Synopsis Quality Control and Quality Assurance by :
Download or read book Quality Control and Quality Assurance written by and published by BoD – Books on Demand. This book was released on 2024-05-29 with total page 312 pages. Available in PDF, EPUB and Kindle. Book excerpt: In any engineering field (including manufacturing, construction, transportation, aerospace, food and agriculture, oil and gas, etc.), ensuring product quality is fundamental to achieving success. Quality assurance (QA) and quality control (QC) are integral components of managing quality. According to the American Society for Quality (ASQ), QA is defined as the part of quality management that focuses on instilling confidence in meeting quality requirements, while QC is concerned with fulfilling those requirements. QA instills confidence internally within the engineering organization’s management and externally with customers, government agencies, regulators, certifiers, and other stakeholders. QA primarily examines how processes are carried out or how products are made, while QC concentrates on product inspection. When QA and QC collaborate effectively, organizational efficiency is enhanced, resulting in superior products. Quality Control and Quality Assurance - Techniques and Applications explores various aspects of quality, including quality planning, QC, QA, and quality enhancement. It covers topics related to QA such as total quality management (TQM), failure testing, process and product quality assurance (PPQA), and statistical process control (SPC). QC includes chapters describing process control, control charts, acceptance sampling, and product quality assessment. For meaningful and easy traceability, the chapters are divided into four sections: “Basics of QA/QC”; “Applications of QA/QC in Industry”; “Applications of QA/QC in Healthcare”; and “Applications of QA/QC in Education”. Covering the latest practices, techniques, and applications in QC and QA, this book is a valuable resource for engineering and business students, practicing engineers, engineering managers, and third-party agencies.
Author :United States Government Accountability Office Publisher :Lulu.com ISBN 13 :0359536395 Total Pages :234 pages Book Rating :4.3/5 (595 download)
Book Synopsis Government Auditing Standards - 2018 Revision by : United States Government Accountability Office
Download or read book Government Auditing Standards - 2018 Revision written by United States Government Accountability Office and published by Lulu.com. This book was released on 2019-03-24 with total page 234 pages. Available in PDF, EPUB and Kindle. Book excerpt: Audits provide essential accountability and transparency over government programs. Given the current challenges facing governments and their programs, the oversight provided through auditing is more critical than ever. Government auditing provides the objective analysis and information needed to make the decisions necessary to help create a better future. The professional standards presented in this 2018 revision of Government Auditing Standards (known as the Yellow Book) provide a framework for performing high-quality audit work with competence, integrity, objectivity, and independence to provide accountability and to help improve government operations and services. These standards, commonly referred to as generally accepted government auditing standards (GAGAS), provide the foundation for government auditors to lead by example in the areas of independence, transparency, accountability, and quality through the audit process. This revision contains major changes from, and supersedes, the 2011 revision.
Book Synopsis The ASQ Certified Quality Auditor Handbook by : Lance B. Coleman
Download or read book The ASQ Certified Quality Auditor Handbook written by Lance B. Coleman and published by Quality Press. This book was released on 2020-02-01 with total page 324 pages. Available in PDF, EPUB and Kindle. Book excerpt: The value of the ASQ Certified Quality Auditor Handbook, Fifth Edition, is clear. It is designed to help new auditors gain an understanding of the field and prepare for the ASQ CQA exam. In addition, experienced auditors can refer to it as a helpful reference; audit managers and quality managers can rely on it for guiding their auditing programs; and trainers and educators can use it for teaching fundamentals. This in-depth overview of quality auditing represents auditing practices for internal and external applications. It provides practical guidance for both system and process auditors as well. Many current topics have been expanded to reflect changes in auditing practices since 2012, with guidance from the recent 2017 update of ISO 19011. In addition, readers will find example audit situations, stories, and review comments to enhance their understanding of the field. Topics covered include the common elements of all types of system and process audits (quality, environmental, safety, and health): Auditing fundamentals, including types of quality audits, purpose and scope of auditing, terms and definitions, roles and responsibilities of participants, and professional conduct The audit process, from preparation and planning, to performance and reporting, to follow-up and closure Auditor competencies, including resource management, conflict resolution, communication, interviewing, and team dynamics Audit program management and business applications, including staffing, training and development, program evaluation, organizational risk management, and best practices Quality tools and techniques, including problem-solving tools, process improvement techniques, basic statistics, verification, and validation "This book is an encyclopedia of all major bodies of information a new or experienced quality auditor would need. It covers both the qualitative and the quantitative, which is a strength. I can't think of a quality auditor that would not find this work helpful." Kim H. Pries, CRE, CQE, CSQE, CSSBB, CMQ/OE, CQA "This handbook will be helpful to those who are new to auditing or require more in-depth knowledge of the implementation of an audit program. Boxed examples or scenarios provide some of the practical challenges encountered during auditing." Govind Ramu, ASQ Fellow, Co-Author ASQ SSGB Handbook, Author ASQ CSSYB Handbook Lance B. Coleman, Sr. has over 25 years of leadership experience in the areas of quality engineering, Lean implementation, quality, and risk management in the Medical Device, Aerospace, and other regulated industries. He has presented, trained, and consulted throughout the United States and abroad. Lance is currently a Director of Quality for IDEX Health and Science, LLC, in Oak Harbor, Washington.
Book Synopsis Standards for Internal Control in the Federal Government by : United States Government Accountability Office
Download or read book Standards for Internal Control in the Federal Government written by United States Government Accountability Office and published by Lulu.com. This book was released on 2019-03-24 with total page 88 pages. Available in PDF, EPUB and Kindle. Book excerpt: Policymakers and program managers are continually seeking ways to improve accountability in achieving an entity's mission. A key factor in improving accountability in achieving an entity's mission is to implement an effective internal control system. An effective internal control system helps an entity adapt to shifting environments, evolving demands, changing risks, and new priorities. As programs change and entities strive to improve operational processes and implement new technology, management continually evaluates its internal control system so that it is effective and updated when necessary. Section 3512 (c) and (d) of Title 31 of the United States Code (commonly known as the Federal Managers' Financial Integrity Act (FMFIA)) requires the Comptroller General to issue standards for internal control in the federal government.
Book Synopsis From Pedagogy to Quality Assurance in Education by : Heidi Flavian
Download or read book From Pedagogy to Quality Assurance in Education written by Heidi Flavian and published by Emerald Group Publishing. This book was released on 2020-09-28 with total page 203 pages. Available in PDF, EPUB and Kindle. Book excerpt: In an increasingly global world, it is more important than ever that educators are equipped to respond to the needs of international student cohorts. This book is a fruitful resource for researchers, educators, and others, who wish to develop new approaches and educational models to contribute to the efficient process of learning.
