Understanding GRAS Submissions and Avoiding Data Pitfalls- Meet FDA Requirements
An EAS Premium Webinar
Presented by Robin Guy and Robert Kapp, Ph.D.
Before a substance can be legally added to food in the U.S., with rare exceptions, it must be either an approved food additive or determined to be generally recognized as safe (GRAS) for use in food.
Developing a food ingredient so that it is ready for GRAS submission can be a time consuming and costly process. Understanding the major components of a GRAS submission, the details of the required sections, and factors FDA considers when reviewing GRAS submissions are imperative to a successful submission and the receipt of subsequent “No Questions” response from FDA.
Join EAS Consulting Group, leaders in FDA regulatory consulting services for a review of GRAS notification requirements, strategies to strengthen preparations and communications with FDA and avoiding GRAS dossier compilation and submission pitfalls. EAS has prepared numerous GRAS notifications, helping clients to gain a new foothold in the marketplace.
This webinar could be one of the most valuable hours of time invested all year.
About the Presenters
Robin Guy is a board certified toxicologist and quality assurance consultant with more than thirty-five years of experience including nineteen years in industry (pharmaceutical toxicology & food ingredient safety assessment) and over nineteen years as an independent consultant. She is an expert in nonclinical toxicology, regulatory and Good Laboratory Practices (GLPs), designing/coordinating toxicology studies and programs, monitoring toxicology studies at CROs, preparing regulatory submissions, including GRAS Notices, upgrading labs to GLP quality and conducting GLP audits, and developing and presenting professional training courses worldwide. Prior to becoming a consultant, she served for eleven years as a toxicologist with The NutraSweet Company/Monsanto, and for eight years with G.D. Searle & Co.
Robert Kapp, Ph.D.
Robert Kapp, Ph.D. has over 30 years’ experience as a toxicologist involved with the management, development, and safety of new and existing products in a broad spectrum of industries including preclinical program study design, study reports, occupational and industrial toxicology and evaluating clinical and product safety data. Dr. Kapp assists EAS clients with writing critical position papers, GRAS notifications, 510(k) submissions, US EPA Premarketing Notifications, toxicology profiles, Safety Data Sheets and labels in the US and in global markets. Prior to consulting Dr. Kapp worked as Director, Toxicology Laboratory at Exxon Biomedical Sciences, Inc. He has a Ph.D. in toxicology from George Washington University.