Excipient World Conferene and Expo 2019-Gaylord Hotel and Conference Center
Inactive ingredients are commonly used in various U.S. Food and Drug Administration (FDA) regulated products such as: cosmetics, food, dietary supplements, nutraceuticals, veterinary products. Pharmaceuticals and combination products. This workshop will provide an overview of differences in regulatory requirements for inactive ingredients used in various regulated products and will discuss strategies for establishing a baseline regulatory dossier that can be used in the above areas. Differences in good manufacturing practice (GMP) expectations will also be discussed and will lead participants in the development of a single flexible GMP quality management system that is appropriate for inactive ingredients intended for multiple regulated markets.