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Author : United States. Food and Drug Administration
Publisher :
ISBN 13 :
Total Pages : 646 pages
Book Rating : 4.:/5 (269 download)
Download or read book FDA Investigations Operations Manual written by United States. Food and Drug Administration and published by . This book was released on 1992 with total page 646 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Food and Drug Administration
Publisher :
ISBN 13 : 9780865879737
Total Pages : 0 pages
Book Rating : 4.8/5 (797 download)
Download or read book FDA Investigations Operations Manual written by Food and Drug Administration and published by . This book was released on 2003 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Available now to FDA-regulated organizations, this manual allows facility managers to look at their operation's regulatory compliance through the eyes of the government. Because this is the primary reference manual used by FDA personnel to conduct field investigation activities, you can feel confident you are preparing appropriate planning or action. This manual includes revised instructions regarding the release of information and covers FDA's policies and expectations on a comprehensive range of topics: FDA's authority to enter and inspect, inspection notification, detailed inspection procedures, recall monitoring, inspecting import procedures, computerized data requests, federal/state inspection relationships, discussions with management regarding privileged information, seizure and prosecution, HACCP, bioengineered food, dietary supplements, cosmetics, bioterrorism, and product disposition. The manual also includes a directory of Office of Regulatory Affairs offices and divisions.
Author : United States Food and Drug Administration
Publisher :
ISBN 13 :
Total Pages : 592 pages
Book Rating : 4.:/5 (112 download)
Download or read book FDA Investigations Operations Manual 2000 written by United States Food and Drug Administration and published by . This book was released on 2000 with total page 592 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : United States. Food and Drug Administration. Division of Field Investigations
Publisher :
ISBN 13 : 9780914176602
Total Pages : 541 pages
Book Rating : 4.1/5 (766 download)
Download or read book FDA Investigations Operations Manual written by United States. Food and Drug Administration. Division of Field Investigations and published by . This book was released on 1994 with total page 541 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Mindy J. Allport-Settle
Publisher : Pharmalogika
ISBN 13 : 9780982147627
Total Pages : 800 pages
Book Rating : 4.1/5 (476 download)
Download or read book Investigations Operations Manual written by Mindy J. Allport-Settle and published by Pharmalogika. This book was released on 2010-01-15 with total page 800 pages. Available in PDF, EPUB and Kindle. Book excerpt: The IOM is the primary guidance document on FDA inspection policy and procedures for field investigators and inspectors. This extends to all individuals who perform field investigational activities in support of the Agency's public mission. Accordingly, it directs the conduct of all fundamental field investigational activities. Adherence to this manual is paramount to assure quality, consistency, and efficiency in field operations. The specific information in this manual is supplemented, not superseded, by other manuals and field guidance documents. The IOM is recommended reading for all operations regulated by the Food and Drug Administration.
Author :
Publisher : Washington Business Information Incorporated
ISBN 13 : 9780914176503
Total Pages : 192 pages
Book Rating : 4.1/5 (765 download)
Download or read book FDA Investigations Operations Manual for Drugs, Devices, Biologics & Cosmetics written by and published by Washington Business Information Incorporated. This book was released on 1993-01-01 with total page 192 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Mindy J. Allport-Settle
Publisher : Pharmalogika
ISBN 13 : 9780982147665
Total Pages : 358 pages
Book Rating : 4.1/5 (476 download)
Download or read book FDA Establishment Inspections written by Mindy J. Allport-Settle and published by Pharmalogika. This book was released on 2010-06-30 with total page 358 pages. Available in PDF, EPUB and Kindle. Book excerpt: Establishment Inspections, Chapter 5 of the FDA's Investigations Operations Manual, details every step FDA inspectors are required to follow when conducting a facility inspection. This text is a comprehensive reference for regulatory inspections and is useful as an introduction to the practical components of the FDA-regulated industries or as a refresher. While the specific regulations and requirements may differ widely between pharmaceutical, biotechnology, medical device, and food manufacturers, the inspection processes and procedures do not.
Author : United States. Food and Drug Administration
Publisher :
ISBN 13 :
Total Pages : 62 pages
Book Rating : 4.3/5 (91 download)
Download or read book FDA Biotechnology Inspection Guide written by United States. Food and Drug Administration and published by . This book was released on 1991 with total page 62 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : National Research Council
Publisher : National Academies Press
ISBN 13 : 0309163587
Total Pages : 589 pages
Book Rating : 4.3/5 (91 download)
Download or read book Enhancing Food Safety written by National Research Council and published by National Academies Press. This book was released on 2010-11-04 with total page 589 pages. Available in PDF, EPUB and Kindle. Book excerpt: Recent outbreaks of illnesses traced to contaminated sprouts and lettuce illustrate the holes that exist in the system for monitoring problems and preventing foodborne diseases. Although it is not solely responsible for ensuring the safety of the nation's food supply, the U.S. Food and Drug Administration (FDA) oversees monitoring and intervention for 80 percent of the food supply. The U.S. Food and Drug Administration's abilities to discover potential threats to food safety and prevent outbreaks of foodborne illness are hampered by impediments to efficient use of its limited resources and a piecemeal approach to gathering and using information on risks. Enhancing Food Safety: The Role of the Food and Drug Administration, a new book from the Institute of Medicine and the National Research Council, responds to a congressional request for recommendations on how to close gaps in FDA's food safety systems. Enhancing Food Safety begins with a brief review of the Food Protection Plan (FPP), FDA's food safety philosophy developed in 2007. The lack of sufficient detail and specific strategies in the FPP renders it ineffectual. The book stresses the need for FPP to evolve and be supported by the type of strategic planning described in these pages. It also explores the development and implementation of a stronger, more effective food safety system built on a risk-based approach to food safety management. Conclusions and recommendations include adopting a risk-based decision-making approach to food safety; creating a data surveillance and research infrastructure; integrating federal, state, and local government food safety programs; enhancing efficiency of inspections; and more. Although food safety is the responsibility of everyone, from producers to consumers, the FDA and other regulatory agencies have an essential role. In many instances, the FDA must carry out this responsibility against a backdrop of multiple stakeholder interests, inadequate resources, and competing priorities. Of interest to the food production industry, consumer advocacy groups, health care professionals, and others, Enhancing Food Safety provides the FDA and Congress with a course of action that will enable the agency to become more efficient and effective in carrying out its food safety mission in a rapidly changing world.
Author :
Publisher :
ISBN 13 : 9789994057146
Total Pages : pages
Book Rating : 4.0/5 (571 download)
Download or read book Investigations Operations Manual written by and published by . This book was released on with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309212456
Total Pages : 318 pages
Book Rating : 4.3/5 (92 download)
Download or read book Medical Devices and the Public's Health written by Institute of Medicine and published by National Academies Press. This book was released on 2011-10-25 with total page 318 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the FDA 510(k) process. In recent years, individuals and organizations have expressed concern that the 510(k) process is neither making safe and effective devices available to patients nor promoting innovation in the medical-device industry. Several high-profile mass-media reports and consumer-protection groups have profiled recognized or potential problems with medical devices cleared through the 510(k) clearance process. The medical-device industry and some patients have asserted that the process has become too burdensome and is delaying or stalling the entry of important new medical devices to the market. At the request of the FDA, the Institute of Medicine (IOM) examined the 510(k) process. Medical Devices and the Public's Health examines the current 510(k) clearance process and whether it optimally protects patients and promotes innovation in support of public health. It also identifies legislative, regulatory, or administrative changes that will achieve the goals of the 510(k) clearance process. Medical Devices and the Public's Health recommends that the U.S. Food and Drug Administration gather the information needed to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices. According to the report, the FDA's finite resources are best invested in developing an integrated premarket and postmarket regulatory framework.
Author : National Academies of Sciences, Engineering, and Medicine
Publisher : National Academies Press
ISBN 13 : 0309377722
Total Pages : 473 pages
Book Rating : 4.3/5 (93 download)
Download or read book Improving Diagnosis in Health Care written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2015-12-29 with total page 473 pages. Available in PDF, EPUB and Kindle. Book excerpt: Getting the right diagnosis is a key aspect of health care - it provides an explanation of a patient's health problem and informs subsequent health care decisions. The diagnostic process is a complex, collaborative activity that involves clinical reasoning and information gathering to determine a patient's health problem. According to Improving Diagnosis in Health Care, diagnostic errors-inaccurate or delayed diagnoses-persist throughout all settings of care and continue to harm an unacceptable number of patients. It is likely that most people will experience at least one diagnostic error in their lifetime, sometimes with devastating consequences. Diagnostic errors may cause harm to patients by preventing or delaying appropriate treatment, providing unnecessary or harmful treatment, or resulting in psychological or financial repercussions. The committee concluded that improving the diagnostic process is not only possible, but also represents a moral, professional, and public health imperative. Improving Diagnosis in Health Care, a continuation of the landmark Institute of Medicine reports To Err Is Human (2000) and Crossing the Quality Chasm (2001), finds that diagnosis-and, in particular, the occurrence of diagnostic errorsâ€"has been largely unappreciated in efforts to improve the quality and safety of health care. Without a dedicated focus on improving diagnosis, diagnostic errors will likely worsen as the delivery of health care and the diagnostic process continue to increase in complexity. Just as the diagnostic process is a collaborative activity, improving diagnosis will require collaboration and a widespread commitment to change among health care professionals, health care organizations, patients and their families, researchers, and policy makers. The recommendations of Improving Diagnosis in Health Care contribute to the growing momentum for change in this crucial area of health care quality and safety.
Author : Agency for Healthcare Research and Quality/AHRQ
Publisher : Government Printing Office
ISBN 13 : 1587634333
Total Pages : 396 pages
Book Rating : 4.5/5 (876 download)
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 396 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.
Author : Richard A. Goodman
Publisher : Oxford University Press
ISBN 13 : 9780199748280
Total Pages : 608 pages
Book Rating : 4.7/5 (482 download)
Download or read book Law in Public Health Practice written by Richard A. Goodman and published by Oxford University Press. This book was released on 2006-11-23 with total page 608 pages. Available in PDF, EPUB and Kindle. Book excerpt: Continually changing health threats, technologies, science, and demographics require that public health professionals have an understanding of law sufficient to address complex new public health challenges as they come into being. Law in Public Health Practice, Second Edition provides a thorough review of the legal basis and authorities for the core elements of public health practice and solid discussions of existing and emerging high-priority areas where law and public health intersect. As in the previous edition, each chapter is authored jointly by experts in law and public health. This new edition features three completely new chapters, with several others thoroughly revised and updated. New chapters address such topics as the structure of law in US public health systems and practice, the role of the judiciary in public health, and law in chronic disease prevention and control. The chapter on public health emergencies has also been fully revised to take into account both the SARS epidemic of 2003 and the events of the Fall of 2001. The chapter now discusses topics such as the legal basis for declaring emergencies, the legal structure of mutual aid agreements, and the role of the military in emergencies. Other fully revised chapters include those on genomics, injury prevention, identifiable health information, and ethics in the practice of public health. The book begins with a section on the legal basis for public health practice, including foundations and structure of the law, discussions of the judiciary, ethics and practice of public health, and criminal law and international considerations. The second section focuses on core public health applications and the law, and includes chapters on legal counsel for public health practitioners, legal authorities for interventions in public health emergencies, and considerations for special populations. The third section discusses the law in controlling and preventing diseases, injuries, and disabilities. This section includes chapters on genomics, vaccinations, foodborne illness, STDs, reproductive health, chronic disease control, tobacco use, and occupational and environmental health. All chapters take a practical approach and are written in an accessible, user-friendly fashion. This is an excellent resource for a wide readership of public health practitioners, lawyers, and healthcare providers, as well as for educators and students of law and public health.
Author : United States. Food and Drug Administration. Medical Library
Publisher :
ISBN 13 :
Total Pages : 136 pages
Book Rating : 4.3/5 (91 download)
Download or read book FDA Medical Library Serials Holdings List written by United States. Food and Drug Administration. Medical Library and published by . This book was released on 1995 with total page 136 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Sylvia A. Bullock
Publisher :
ISBN 13 :
Total Pages : 136 pages
Book Rating : 4.3/5 (121 download)
Download or read book FDA Medical Library Serials Holdings List written by Sylvia A. Bullock and published by . This book was released on 1995 with total page 136 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : United States. Food Safety and Inspection Service. Microbiology Division
Publisher :
ISBN 13 :
Total Pages : 556 pages
Book Rating : 4.:/5 (319 download)
Download or read book Microbiology Laboratory Guidebook written by United States. Food Safety and Inspection Service. Microbiology Division and published by . This book was released on 1998 with total page 556 pages. Available in PDF, EPUB and Kindle. Book excerpt:
