FDA Inspection Operations Manual
Author :
Publisher :
Page : 26 pages
File Size : 45,87 MB
Release : 1990
Category : Drugs
ISBN :
Author :
Publisher :
Page : 26 pages
File Size : 45,87 MB
Release : 1990
Category : Drugs
ISBN :
Author : Food and Drug Administration
Publisher :
Page : 0 pages
File Size : 49,20 MB
Release : 2003
Category : Drugs
ISBN : 9780865879737
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 :
Publisher :
Page : 0 pages
File Size : 37,93 MB
Release : 1987
Category : Drugs
ISBN :
Author : United States. Food and Drug Administration
Publisher :
Page : 62 pages
File Size : 21,63 MB
Release : 1991
Category : Biotechnology
ISBN :
Author :
Publisher :
Page : pages
File Size : 13,85 MB
Release : 1990
Category : Drugs
ISBN :
Author : United States. Department of Health and Human Services
Publisher :
Page : 172 pages
File Size : 17,18 MB
Release : 1983
Category : Health & Fitness
ISBN :
Author : National Research Council
Publisher : National Academies Press
Page : 589 pages
File Size : 37,79 MB
Release : 2010-11-04
Category : Medical
ISBN : 0309163587
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 :
Page : 74 pages
File Size : 42,51 MB
Release : 1997
Category : Meat
ISBN :
Author : Institute of Medicine
Publisher : National Academies Press
Page : 88 pages
File Size : 10,83 MB
Release : 1999-07-27
Category : Medical
ISBN : 0309172802
In an effort to increase knowledge and understanding of the process of assuring data quality and validity in clinical trials, the IOM hosted a workshop to open a dialogue on the process to identify and discuss issues of mutual concern among industry, regulators, payers, and consumers. The presenters and panelists together developed strategies that could be used to address the issues that were identified. This IOM report of the workshop summarizes the present status and highlights possible strategies for making improvements to the education of interested and affected parties as well as facilitating future planning.
Author : United States. Food Safety and Inspection Service. Microbiology Division
Publisher :
Page : 634 pages
File Size : 42,87 MB
Release : 1998
Category : Agricultural microbiology
ISBN :