Daniel Peng, Ph.D. is currently a Quality Assessment Lead in the Office of Process and Facility (OPF), within the Office of Pharmaceutical Quality (OPQ)/CDER/FDA. The main responsibilities for OPF are to ensure quality is built into the manufacturing processes for new drugs, generic drugs and biotech products by providing oversight of process review, microbiological review and pre-approval inspections. Daniel has been involved in numerous OGD, OPQ, and CDER committees and working groups regarding Quality by Design (QbD). Previously, Dr. Peng served as a Senior Formulation Scientist/Project Lead in Product Development at AstraZeneca (Wilmington, DE) for five years and an Instructor (faculty) at College of Pharmacy, University of Tennessee Health Science Center (Memphis, TN) for 6 years. Dr. Peng obtained his Ph.D. in Pharmaceutics from West China University of Medical Sciences (Chengdu, China). He has published 3 book chapters, 16 peer reviewed papers and 4 US patents. Dr. Peng has extensive experience in formulation and process development for solid oral dosage forms and novel drug delivery systems. He is also skilled in applying Design of Experiments (DOE), Multivariate analysis (MVA), Statistical Process Control (SPC), and Artificial Neural Network (ANN) software for pharmaceutical product development.