Derek Smith

Deputy Director, Office of Pharmaceutical Manufacturing Assessment (OPMA)

Derek Smith is Deputy Director of the Office of Pharmaceutical Manufacturing Assessment in the Office of Pharmaceutical Quality providing leadership of the assessment of the manufacturing process and facilities for biologics and small molecule drug applications with a focus on the integration of application assessment and inspection findings and data reliability assessments. He also serves as the co-chair for FDA's New Inspection Protocol Project (NIPP) initiative for pre-approval inspections and remote assessments. During the COVID-19 pandemic, he has led CDER's efforts on inspection and a key contributor to the utilization of alternatives to inspections. He holds a PhD in Chemical and Biochemical Engineering from University of Maryland, Baltimore County.

Talks About
#pharmaceuticalmanufacturing

Preferred Locations
#NorthAmerica