Jason J. Orloff, ChE PharmStat

Jason J. Orloff, Chemical Eng & M.S. Applied Statistics, has worked in the pharmaceutical industry since 1999. He is the Principal Statistician at PharmStat, which he started in 2010. Most recently he consulted with the World Health Organization on implementing QbD in vaccine manufacturing development.  He specializies in CMC statistics and the design of experiments for 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. Areas of expertise include Sampling, 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  parenterals, solid oral dose, capsues, biotechnology, fine chemicals, medical devices, food, and nanotechnology.