Date: May 21, 2018
Daniel Rubenstein will host an encore presentation of "Good Manufacturing Practice in FDA Regulated Facilities" at the Institute of Industrial Engineers' Annual Conference and Expo in Orlando, Florida on May 21, 2018. The presentation will explore the relationship between Industrial Engineering and the Food and Drug Administration’s (FDA) Good Manufacturing Practice (GMP) requirement, as it relates to Food and Drug Law.
Mr. Rubenstein’s article on this same topic, Getting to Good: Good Manufacturing Practice in FDA-Regulated Facilities, was recently featured in the January 2018 edition of Industrial and Systems Engineering (ISE) Magazine. For additional information and a full copy of the article, click here.
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. This presentation will include an overview of the principles of industrial engineering that are used to demonstrate that a food-contact material is manufactured in accordance with GMP, including a discussion of facility design, process control, recordkeeping, and the continuing evolution of best practices.
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