Rapti Madurawe is a Division Director in the Office of Process and Facilities, Office of Pharmaceutical Quality, FDA. She has extensive regulatory experience in the CMC assessment of new, investigational drug and generic drug applications. She is FDA’s topic lead for the ICH Q13 guidance on Continuous Manufacturing. Prior to joining the FDA, Rapti worked in biotech and biopharmaceutical companies and has industry experience in process development, process scale up and manufacturing tech support. Rapti has a Ph.D. in Chemical Engineering from Virginia Tech, USA and a Master’s degree in Biochemistry from the University of Kentucky, USA.