Jason J. Orloff, Ch.E. & M.S. Applied Statistics is a Principal Statistical Consultant at PharmStat and a proud colleague of Lynn Torbeck of Torbeck and Associates, both located in Evanston, IL. He is an international consultant specializing in applied statistics and experimental design for pharmaceutical and biopharmaceutical development, quality assurance, quality control, validation, and production under the cGXP's. Current activities include an author of ISPE’s Baseline Guide for Q10 chapter “Process Performance and Product Quality Monitoring”, contributing authorship of the PDA’s Technical Report 59 on “Utilization of Statistical Methods for Production and Business Processes”, and publications in the Journal of Pharmaceutical Technology. Mr. Orloff brings over ten years of experience in manufacturing, quality, and regulatory affairs in the pharmaceutical industry. Areas of expertise include PAT, OOS, SQC, SPC, assay validation and setting specification criteria. A Chemical Engineer with real-life expertise at applying statistics in a highly regulated environment, Mr. Orloff is able to work effectively across all levels of an organization as well as make high level concepts accessible to a variety of audiences. Mr. Orloff has worked with a wide variety of companies including pharmaceuticals, parenterals, biotechnology, fine chemicals, medical devices, food, and nanotechnology. He holds a BS in Chemical Engineering from UW-Madison and an MS degree in Applied Statistics from DePaul University.