Quality Assurance And Quality Management In Pharmaceutical Industry

Quality Assurance And Quality Management In Pharmaceutical Industry

Author: Anjaneyulu Marayya

Publisher:

Published: 2018-06

Total Pages: 0

ISBN-13: 9788188449149

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QA is the most vital function of Total Quality Management (TQM) in pharmaceutical industry. This book presents the basic concepts on various topics like QMS, GLP, GMP, Quality Audit, Statistical Quality Control and analytica methods for QA. The elements, requirement and interpretation of ISO 9000 series of QMS are presented in detail.


Toward Quality Assurance and Excellence in Higher Education

Toward Quality Assurance and Excellence in Higher Education

Author: Al Jaber, Ahmed Odeh

Publisher: River Publishers

Published: 2018-08-15

Total Pages: 452

ISBN-13: 8793609558

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Quality Assurance is not a new concept in the education sector in general, and higher education in particular, though it is becoming increasingly more relevant and important. Higher education helps to improve an individual's quality of life by enabling them to inflate their knowledge and expertise, to grasp abstract concepts and theories, and to raise their awareness of the world and their community, and as such the assurance of quality is becoming more pivotal in the whole education process. There is no simple definition of the concept of quality in education, though numerous models and theories have been devised. Toward Quality Assurance and Excellence of Higher Education is a new episode of the Quality Assurance perception in higher education, which identifies the quality culture and orientation from the beginning, integrating crucial factors to build a “pyramid” of higher education excellence. The book compares concepts from the main theories of Quality Assurance, management and control when they are applied to educational systems in higher education. The book also presents a new model of excellence in higher education. Excellence is an architecture of building blocks that includes process performance, effectiveness, harmony and collaboration, and these bocks should be incorporated in a quality-oriented concept for sustainable excellence of higher education. The model integrates four main facets: the Educational System, Quality Assurance Managing and Control, Strategic Planning and Globalization. Also presented are international “best-practices” in quality assurance in higher education, from Japan and Finland.


Registries for Evaluating Patient Outcomes

Registries for Evaluating Patient Outcomes

Author: Agency for Healthcare Research and Quality/AHRQ

Publisher: Government Printing Office

Published: 2014-04-01

Total Pages: 385

ISBN-13: 1587634333

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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.


An Introduction to Quality Assurance in Health Care

An Introduction to Quality Assurance in Health Care

Author: Avedis Donabedian

Publisher: Oxford University Press

Published: 2002-12-26

Total Pages: 233

ISBN-13: 0199748020

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Avedis Donabedian's name is synonymous with quality of medical care. He unraveled the mystery behind the concept by defining it in clear operational terms and provided detailed blueprints for both its measurement(known as quality assessment) and its improvement(known as quality assurance). Many before him claimed that quality couldn't be defined in concrete objective terms. He demonstrated that quality is an attribte of a system which he called structure, a set of organized activities whihc he called process, and an outcome which results from both. In this book Donabedian tells the full story of quality assessment and assurance in simple, clear terms. He defines the meaning of quality, explicates its components, and provides clear and systematic guides to its assessment and enhancement. His style is lucid, succinct, systematic and yet personal, almost conversational.


Quality Assurance and Quality Management

Quality Assurance and Quality Management

Author: Y. Anjaneyulu

Publisher: Pharmamed Press

Published: 2018-12-07

Total Pages: 380

ISBN-13: 9789352300730

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Quality Assurance (QA) is a measure of the degree of sophistication of managerial, scientific and technical tools used in the design and implementation of product process of any industry. QA is the most vital function of Total Quality Management (TQM) in pharmaceutical industry. This book presents the basic concepts on various topics like QMS, GLP, GMP, Quality Audit, Statistical Quality Control and analytical methods for QA. The elements, requirement and interpretation of ISO 9000 series of QMS are presented in detail. The principles of GLP and GMP are discussed which are expected to guide the manufacturer and the regulator for maintaining high scientific and professional standards for ensuring only drugs of highest quality are produced and marketed. Each chapter is provided with a summary and typical questions and in Appendix, the latest information on the International Standards of QMS, GLP and GMP are included for ready reference. "As very few books are available on this important subject, this book will be very useful as text book for students of both graduate and post-graduate classes in Pharmacy, Analytical Chemistry and allied subjects. It shall serve as ready reference for scientific and management personnel working in various pharmaceutical industries for understanding the basic concep


Global Perspectives on Quality Assurance and Accreditation in Higher Education Institutions

Global Perspectives on Quality Assurance and Accreditation in Higher Education Institutions

Author: Magd, Hesham

Publisher: IGI Global

Published: 2021-09-17

Total Pages: 378

ISBN-13: 1799880877

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Quality accreditation in higher education institutions (HEIs) is currently a buzzword. The need to maintain high-quality education standards is a critical requirement for HEIs to remain competitive in the market and for government and regulatory bodies to ensure the quality standards of programs offered. From being an implicit requirement that is internally addressed, quality assurance activities become an explicit requirement that is regularly audited and appraised by national and international accreditation agencies. HEIs are voluntarily integrating quality management systems (QMS), institutional and program-specific, in response to the political and competitive environment in which it exists. Through its higher education department or by creating non-profitable accreditation bodies, many governments have implemented a quality framework for licensing HEIs and invigilates its adherence based on which accreditation statuses are granted for HEIs. Global Perspectives on Quality Assurance and Accreditation in Higher Education Institutions provides a comprehensive framework for HEIs to address quality assurance and quality accreditation requirements and serves as a practical tool to develop and deploy well-defined quality management systems in higher education. The book focuses on the critical aspects of quality assurance; the need to develop a concise and agile vision, mission, values, and graduate attributes; and to develop a system that effectively aligns the various activities of the HEI to the attainment of the strategic priorities listed in the institutional plans. The chapters each cover the various facets of the quality assurance framework and accreditation agencies' requirements with practical examples of each. This book is useful for HEI administrators, quality assurance specialists in HEIs, heads of academic departments, internal auditors, external auditors, and other practitioners of quality, along with stakeholders, researchers, academicians, and students interested in quality assurance and accreditation in higher education.


Encyclopedia of Information Communication Technology

Encyclopedia of Information Communication Technology

Author: Cartelli, Antonio

Publisher: IGI Global

Published: 2008-07-31

Total Pages: 888

ISBN-13: 1599048469

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NetLibrary named the Encyclopedia of Information Communication Technology as their September 2008 e-book of the month! CLICK HERE to view the announcement. The Encyclopedia of Information Communication Technology (ICT) is a comprehensive resource describing the influence of information communication technology in scientific knowledge construction, with emphasis on the roles of product technologies, process technologies, and context technologies. Through 111 authoritative contributions by 93 of the world's leading experts this reference covers the materials and instruments of information technology: from ICT in education to software engineering; the influence of ICT on different environments, including e-commerce, decision support systems, knowledge management, and more; and the most pervasive presence of information technology, including studies and research on knowledge management, the human side of ICT, ICT in healthcare, and virtual organizations, among many others. Addressing many of the fundamental issues of information communication technology, the Encyclopedia of Information Communication Technology will be a top-shelf resource for any reference library.


Quality Control with R

Quality Control with R

Author: Emilio L. Cano

Publisher: Springer

Published: 2015-11-20

Total Pages: 373

ISBN-13: 3319240463

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Presenting a practitioner's guide to capabilities and best practices of quality control systems using the R programming language, this volume emphasizes accessibility and ease-of-use through detailed explanations of R code as well as standard statistical methodologies. In the interest of reaching the widest possible audience of quality-control professionals and statisticians, examples throughout are structured to simplify complex equations and data structures, and to demonstrate their applications to quality control processes, such as ISO standards. The volume balances its treatment of key aspects of quality control, statistics, and programming in R, making the text accessible to beginners and expert quality control professionals alike. Several appendices serve as useful references for ISO standards and common tasks performed while applying quality control with R.


Quality Management Implementation in Higher Education: Practices, Models, and Case Studies

Quality Management Implementation in Higher Education: Practices, Models, and Case Studies

Author: Sony, Michael

Publisher: IGI Global

Published: 2019-08-02

Total Pages: 483

ISBN-13: 1522598316

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Although initially utilized in business and industrial environments, quality management systems can be adapted into higher education to assess and improve an institution’s standards. These strategies are now playing a vital role in educational areas such as teaching, learning, and institutional-level practices. However, quality management tools and models must be adapted to fit with the culture of higher education. Quality Management Implementation in Higher Education: Practices, Models, and Case Studies is a pivotal reference source that explores the challenges and solutions of designing quality management models in the current educational culture. Featuring research on topics such as Lean Six Sigma, distance education, and student supervision, this book is ideally designed for school board members, administrators, deans, policymakers, stakeholders, professors, graduate students, education professionals, and researchers seeking current research on the applications and success factors of quality management systems in various facets of higher education.