Steven Hertz MBA, PE

Mr. Hertz is an officer in FDA’s Center for Drug Evaluation and Research, Office of Pharmaceutical Quality. He has been with FDA since 2008 and his work is focused on pre-approval manufacturing assessment for CDER-led and CDRH-led submissions. He has participated on both domestic and international drug product and combination product pre-approval inspections. He is an office subject matter expert for issues regarding computer validation, combination products, control systems, electronic records, bio-pharmaceutical engineering, QbD, PAT, and process validation. Mr. Hertz also has 5+ years’ experience working in the biotechnology industry. His previous projects focused on process control, system administration, equipment automation, engineering, risk management, computer system validation, and process validation. He earned his B.S. in chemical engineering from the University of Virginia, his M.S. in biotechnology and his M.B.A. from Johns Hopkins University, and is a licensed Professional Engineer in the state of Maryland.