Metrics: the Balance of Performance & Compliance
Regis Technologies invites you for a seminar on "Metrics: the Balance of Performance & Compliance" delivered by guest speaker Jason J. Orloff, a chemical engineer and international consultant with over 15 years in the industry. Read the abstract below for more details. A light breakfast will be served.
Join us for coffee and chemistry on Thursday, November 12th, 8-9:30AM.
Coffee served at 8:00am; presentation begins at 8:30am; Q&A at 9:30am.
Metrics: the Balance of Performance & Compliance
Jason J. Orloff
Wave after wave of quality initiatives have come from other industries and failed to take root. This could be because Pharmaceutical Quality Culture is unlike any other industrial culture. Certainly our risk profile of medium volumes, high costs, and high risks are radically different from the high volumes, low risk, low costs of cell phones, cars, and computer chips. Pharmaceutical Quality Culture is a dynamic, self-correcting system that represents both compliance and performance. A maximally efficient, agile, flexible, pharmaceutical manufacturing sector could be achieved with minimal regulatory oversight by formalizing the systems of performance and ensuring that the balance of compliance and performance is maintained. Process capability measured in %OOS is one such metric where compliance with specifications is weighed against the performance of the process. But where does process capability itself belong: As a compliance reportable? Or as a self-audit of performance done by manufacturing for senior management to prioritize continuous improvement?
Jason J. Orloff
Jason J. Orloff, Ch.E. & M.S. Applied Statistics is a Principal Statistical Consultant at PharmStat and a proud colleague of Lynn Torbeck. 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,” DoE trainer at CBER, and publications in the Journal of Pharmaceutical Technology. Mr. Orloff brings over fifteen 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.