Daniel Rubenstein to Host "Technical Talk: Good Manufacturing Practice in FDA Regulated Facilities"

Date: Sep 27, 2017

Daniel Rubenstein will host “Technical Talk: Good Manufacturing Practice in FDA Regulated Facilities“ at Keller and Heckman’s Washington, D.C. Office on September 27, 2017 from 6-8 PM. This presentation will include an overview of how FDA-regulated materials are manufactured in accordance with Good Manufacturing Practice (GMP), including a discussion of relevant Industrial Engineering concepts that play a crucial part in the continuing evolution of best practices across the industry, such as facility design, process control, and recordkeeping. The event is open to members of the Institute for Industrial and Systems Engineers (IISE), The Institute for Operations Research and the Management Sciences (INFORMS), The International Council on Systems Engineering (INCOSE) and The American Society for Quality (ASQ).
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Join the National Capital Chapter of IISE as we host an encore performance of one of the most popular talks at the recent IISE Annual Conference in Pittsburgh. Nat Cap Member and IE-turned-Attorney Danny Rubenstein will welcome us to the downtown offices of his firm, Keller and Heckman, for this engaging presentation. The evening will begin with networking, followed by the technical presentation. Admission is free and includes appetizers and soft drinks, but you must register on Eventbrite by September 22nd. The venue is Metro accessible from all lines. 


Abstract:

Food packaging materials that are sold or marketed in the United States are subject to various regulatory and legal requirements – many of which are set forth by the U.S. Food and Drug Administration (FDA). In addition to meeting various compositional and purity requirements, FDA also requires that appropriate measures be taken to ensure that these materials are “safe and suitable” for their intended use. FDA’s Good Manufacturing Practice (GMP) requirement is both broad-reaching and essential, but largely silent on specific requirements. Therefore, material manufacturers, converters, and customers must determine how best to ensure that the GMP requirement is satisfied. Principles of Industrial Engineering play a critical role in accomplishing this objective.