Food Regulation

Food Regulation

Author: Neal D. Fortin

Publisher: John Wiley & Sons

Published: 2016-11-02

Total Pages: 547

ISBN-13: 1118964489

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Featuring case studies and discussion questions, this textbook – with revisions addressing significant changes to US food law – offers accessible coverage appropriate to a wide audience of students and professionals. Overviews the federal statutes, regulations, and regulatory agencies concerned with food regulation and introduces students to the case law and statutory scheme of food regulation Focuses updated content on the 2011 FDA Food Safety Modernization Act (FSMA), the biggest change to US food law since the 1930s Contains over 20% new material, particularly a rewritten import law chapter and revisions related to food safety regulation, health claims, and food defense Features case studies and discussion questions about application of law, policy questions, and emerging issues


Process Validation in Manufacturing of Biopharmaceuticals, Third Edition

Process Validation in Manufacturing of Biopharmaceuticals, Third Edition

Author: Anurag S. Rathore

Publisher: CRC Press

Published: 2012-05-09

Total Pages: 535

ISBN-13: 1439850933

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Process Validation in Manufacturing of Biopharmaceuticals, Third Edition delves into the key aspects and current practices of process validation. It includes discussion on the final version of the FDA 2011 Guidance for Industry on Process Validation Principles and Practices, commonly referred to as the Process Validation Guidance or PVG, issued in final form on January 24, 2011. The book also provides guidelines and current practices, as well as industrial case studies illustrating the different approaches that can be taken for successful validation of biopharmaceutical processes. Case studies include Process validation for membrane chromatography Leveraging multivariate analysis tools to qualify scale-down models A matrix approach for process validation of a multivalent bacterial vaccine Purification validation for a therapeutic monoclonal antibody expressed and secreted by Chinese Hamster Ovary (CHO) cells Viral clearance validation studies for a product produced in a human cell line A much-needed resource, this book presents process characterization techniques for scaling down unit operations in biopharmaceutical manufacturing, including chromatography, chemical modification reactions, ultrafiltration, and microfiltration. It also provides practical methods to test raw materials and in-process samples. Stressing the importance of taking a risk-based approach towards computerized system compliance, this book will help you and your team ascertain process validation is carried out and exceeds expectations.


Enhancing Food Safety

Enhancing Food Safety

Author: National Research Council

Publisher: National Academies Press

Published: 2010-11-04

Total Pages: 589

ISBN-13: 0309163587

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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.


The United States Government Internet Directory 2016

The United States Government Internet Directory 2016

Author: Adam Jacobs

Publisher: Bernan Press

Published: 2016-07-26

Total Pages: 705

ISBN-13: 159888834X

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Discover the depth of government information and services available online. The United States Government Internet Directory serves as a guide to the changing landscape of government information online. The Directory is an indispensable guidebook for anyone who is looking for official U.S. government resources on the Web. The U.S. government's online information is massive and can be difficult to locate. Many government sites are part of the "Deep Web" with content that does not surface or surface easily with even the most popular search engines. It is more important than ever to have a source that serves as an authoritative guide to the federal Web. The United States Government Internet Directory navigates the maze of data and locates the materials that you seek. The subject-based approach of this book allows you to browse for relevant sites in your field of interest rather than sift through hundreds of search results or try to guess which federal agency to consult. Researchers, business people, teachers, students, and citizens in the United States and around the world can navigate the labyrinthine federal Web with The United States Government Internet Directory. The Directory: contains more than 1,800 Web site records, organized into 21 subject themed chapters includes topics on a wide-range of subjects including employment, energy, defense and intelligence, culture and recreation, and much more provides descriptions and URLs for each site describes sites to help you choose the proper resource notes the useful or unique aspects of the site lists some of the major government publications hosted on the site provides a roster of congressional members with member's Web sites lists House and Senate Committees with committee URLs contains useful, up-to-date organizational charts for the major federal government agencies includes a one-page Quick Guide to the major federal agencies and the leading online library, data source, and finding aid sites identifies the major government Web sites related to the global recession and new government economic recovery programs