Dr. Shanthi Sethuraman has over 15 years of experience in the Pharmaceutical Industry in fields of statistical thinking and applications, Quality By Design, Chemical Product R&D, Operational Excellence and Process Improvements. She has responsible globally for statistical thinking across small and large molecules, API and Drug Product on appropriate use of statistical methodologies, process improvements, establishing best practices in process monitoring, Designed Experimentation, variability reduction and use of sound statistical applications in Quality systems. Areas of impact include R&D (Product, Process and Analytical Sciences), Manufacturing and Quality. She continues to be involved internally and externally in QbD and Process Verification related initiatives through chairing sessions and publications. Currently she chairs for AAPS Statistics Expert Focus Group and is the Director of Regulatory Center of Excellence at Eli Lilly and Company.