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Author : United States. Food and Drug Administration
Publisher :
ISBN 13 :
Total Pages : 646 pages
Book Rating : 4.92/5 ( 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 : 4.37/5 ( 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 : 4.87/5 ( 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 : 4.09/5 ( 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 : 4.27/5 ( 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 : 4.01/5 ( 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 : 4.6X/5 ( 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 : 4.78/5 ( 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 : 4.83/5 ( 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 : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309212456
Total Pages : 318 pages
Book Rating : 4.58/5 ( 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.
