FDA Investigations Operations Manual
FDA Investigations Operations Manual

Author: Food and Drug Administration

Publisher:

Published: 2003

Total Pages: 0

ISBN-13: 9780865879737

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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.

Fish and Fishery Products
Fish and Fishery Products

Author: Barry Leonard

Publisher: DIANE Publishing

Published: 2011-08

Total Pages: 476

ISBN-13: 143798746X

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This guidance will assist processors of fish and fishery products in the development of their Hazard Analysis Critical Control Point (HACCP) plans. Processors of fish and fishery products will find info. that will help them identify hazards that are associated with their products, and help them formulate control strategies. It will help consumers understand commercial seafood safety in terms of hazards and their controls. It does not specifically address safe handling practices by consumers or by retail estab., although the concepts contained in this guidance are applicable to both. This guidance will serve as a tool to be used by fed. and state regulatory officials in the evaluation of HACCP plans for fish and fishery products. Illustrations. This is a print on demand report.

Model Rules of Professional Conduct
Model Rules of Professional Conduct

Author: American Bar Association. House of Delegates

Publisher: American Bar Association

Published: 2007

Total Pages: 216

ISBN-13: 9781590318737

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The Model Rules of Professional Conduct provides an up-to-date resource for information on legal ethics. Federal, state and local courts in all jurisdictions look to the Rules for guidance in solving lawyer malpractice cases, disciplinary actions, disqualification issues, sanctions questions and much more. In this volume, black-letter Rules of Professional Conduct are followed by numbered Comments that explain each Rule's purpose and provide suggestions for its practical application. The Rules will help you identify proper conduct in a variety of given situations, review those instances where discretionary action is possible, and define the nature of the relationship between you and your clients, colleagues and the courts.

HIV and the Blood Supply
HIV and the Blood Supply

Author: Institute of Medicine

Publisher: National Academies Press

Published: 1995-10-05

Total Pages: 349

ISBN-13: 0309053293

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During the early years of the AIDS epidemic, thousands of Americans became infected with HIV through the nation's blood supply. Because little reliable information existed at the time AIDS first began showing up in hemophiliacs and in others who had received transfusions, experts disagreed about whether blood and blood products could transmit the disease. During this period of great uncertainty, decision-making regarding the blood supply became increasingly difficult and fraught with risk. This volume provides a balanced inquiry into the blood safety controversy, which involves private sexual practices, personal tragedy for the victims of HIV/AIDS, and public confidence in America's blood services system. The book focuses on critical decisions as information about the danger to the blood supply emerged. The committee draws conclusions about what was doneâ€"and recommends what should be done to produce better outcomes in the face of future threats to blood safety. The committee frames its analysis around four critical area: Product treatmentâ€"Could effective methods for inactivating HIV in blood have been introduced sooner? Donor screening and referralâ€"including a review of screening to exlude high-risk individuals. Regulations and recall of contaminated bloodâ€"analyzing decisions by federal agencies and the private sector. Risk communicationâ€"examining whether infections could have been averted by better communication of the risks.