Regulatory Concepts of Pharma, Medical Device and Biotech

Manufacturing and selling products intended for human use requires a basic set of regulatory concepts to be followed. This session will explore the similarities in the basic U.S. regulatory concepts across three regulated product lines: pharmaceuticals, medical devices, and biologics through design, development, and production. Understand the basic regulatory concepts that apply to pharmaceutical, medical device, and biological products in the U.S. Understand the basic elements of GMPs in the U.S.