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.
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.
Download or read book FDA Inspection Operations Manual written by United States. Department of Health and Human Services and published by . This book was released on 1983 with total page 172 pages. Available in PDF, EPUB and Kindle. Book excerpt:
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:
Download or read book Drug Safety written by Marcia Crosse and published by DIANE Publishing. This book was released on 2009-05 with total page 58 pages. Available in PDF, EPUB and Kindle. Book excerpt: The FDA oversees the safety and effectiveness of human drugs marketed in the U.S., including those manufactured in foreign establishments. FDA inspects foreign establishments in order to ensure that the quality of drugs is not jeopardized by poor manufacturing processes. This report examines: (1) the extent to which FDA has accurate data on the number of foreign establishments subject to inspection; (2) the frequency of foreign inspections; and (3) oversight by FDA to ensure that foreign establishments correct serious problems identified during inspections. The author analyzed info. from FDA databases, reviewed inspection reports which identified serious deficiencies, and interviewed FDA officials. Includes recommendations. Illus.
Download or read book Guide to Handling FDA Food Inspections written by Richard Laurence Frank and published by . This book was released on 2002 with total page 124 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Medical Devices FDA Faces Challenges in Conducting Inspections of Foreign Manufacturing Establishments written by Marcia Crosse and published by DIANE Publishing. This book was released on 2008-12 with total page 26 pages. Available in PDF, EPUB and Kindle. Book excerpt: As part of the FDA oversight of the safety and effectiveness of medical devices marketed in the U.S., it inspects certain foreign and domestic establishments where these devices are manufactured. To help FDA address shortcomings in its inspection program, the Medical Device User Fee and Modernization Act of 2002 required FDA to accredit third parties to inspect certain establishments. In response, FDA has implemented two voluntary programs for that purpose. This statement assesses: (1) FDA¿s program for inspecting foreign establishments that manufacture medical devices for the U.S. market; and (2) FDA¿s programs for third-party inspections of those establishments.
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.
Download or read book FDA Inspection Operations Manual written by and published by . This book was released on 1989 with total page 40 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Dictionary of Pharmaceutical Medicine written by Gerhard Nahler and published by Springer Science & Business Media. This book was released on 2013-06-29 with total page 186 pages. Available in PDF, EPUB and Kindle. Book excerpt: This dictionary is aimed primarily at the beginners entering the new discipline of Pharmaceutical Medicine, an area comprising aspects of toxicology, pharmacology, pharmaceutics, epidemiology, statistics, drug regulatory and legal affairs, medicine and marketing. But also more experienced colleagues in departments engaged in clinical development as well as researchers and marketing experts in the pharmaceutical industry will find concise and up-to-date information. The book is completed by a list of a about 1000 abbreviations encountered in pharmaceutical medicine and a compilation of important addresses of national and international health authorities.
Download or read book Drug Safety FDA has Conducted More Foreign Inspections and Begun to Improve Its Information on Foreign Establishments but More Progress Is Needed written by and published by DIANE Publishing. This book was released on with total page 43 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Retail Food Safety written by Jeffrey Farber and published by Springer. This book was released on 2014-10-07 with total page 195 pages. Available in PDF, EPUB and Kindle. Book excerpt: Currently, there is no one book or textbook that covers all aspects of retail food safety. It is becoming apparent that a number of issues relating to retail food safety have come to the forefront in some jurisdictions of late. For example, a recent USDA risk assessment has pointed out that issues occurring at USA retail appear to be critical in terms of contamination of deli-meat. As well, a large listeriosis outbreak in Quebec pointed to retail cross-contamination as a key issue. In terms of sanitation, a number of advances have been made, but these have not all been synthesized together in one chapter, with a focus on retail. In addition, the whole area of private standards and the Global Food Safety Initiative (GFSI) have come to the forefront of late and these as well will be explored in great detail. Other aspects related to the safety of important food commodities such as seafood, meat, produce and dairy will also be discussed and salient areas addressed.
Download or read book Ensuring Safe Food written by Committee to Ensure Safe Food from Production to Consumption and published by National Academies Press. This book was released on 1998-09-02 with total page 209 pages. Available in PDF, EPUB and Kindle. Book excerpt: How safe is our food supply? Each year the media report what appears to be growing concern related to illness caused by the food consumed by Americans. These food borne illnesses are caused by pathogenic microorganisms, pesticide residues, and food additives. Recent actions taken at the federal, state, and local levels in response to the increase in reported incidences of food borne illnesses point to the need to evaluate the food safety system in the United States. This book assesses the effectiveness of the current food safety system and provides recommendations on changes needed to ensure an effective science-based food safety system. Ensuring Safe Food discusses such important issues as: What are the primary hazards associated with the food supply? What gaps exist in the current system for ensuring a safe food supply? What effects do trends in food consumption have on food safety? What is the impact of food preparation and handling practices in the home, in food services, or in production operations on the risk of food borne illnesses? What organizational changes in responsibility or oversight could be made to increase the effectiveness of the food safety system in the United States? Current concerns associated with microbiological, chemical, and physical hazards in the food supply are discussed. The book also considers how changes in technology and food processing might introduce new risks. Recommendations are made on steps for developing a coordinated, unified system for food safety. The book also highlights areas that need additional study. Ensuring Safe Food will be important for policymakers, food trade professionals, food producers, food processors, food researchers, public health professionals, and consumers.
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.
Download or read book Medical Devices Status of FDA s Program for Inspection by Accredited Organizations written by and published by DIANE Publishing. This book was released on with total page 28 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book FDA Inspections of Domestic Food Facilities written by United States. Department of Health and Human Services. Office of Inspector General and published by . This book was released on 2010 with total page 31 pages. Available in PDF, EPUB and Kindle. Book excerpt: Each year, more than 300,000 Americans are hospitalized and 5,000 die after consuming contaminated foods and beverages. Recent high-profile outbreaks of foodborne illness have raised serious questions about FDA's inspections process and its ability to protect the Nation's food supply. The Senate Committee on Agriculture, Nutrition, and Forestry requested that the Office of Inspector General (OIG) review the extent to which FDA conducts food facility inspections and identifies violations. FDA inspects food facilities to ensure food safety and compliance with regulations. During an inspection, FDA inspectors may identify potential violations of the Food, Drug, and Cosmetic Act as well as other applicable laws and regulations. Based on the outcome of the inspection, FDA assigns a facility one of three classifications: official action indicated (OAI), voluntary action indicated (VAI), or no action indicated (NAI). In addition, FDA may choose to change a facility's initial classification to another classification under certain circumstances.
Download or read book FDA Inspection Operations Manual written by and published by . This book was released on 1987 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:
