针对高风险产品理解并应用QRM徐影.ppt

* Just based on EU and FDA text, we immediately see some areas where we can use a RM approach to determine amount of activity required. * * Summarize today’s key points” ” and orally quiz trainees to make sure they are clear. 1 simplified formula risk=P*S (concepts of quality risk management, risk, hazard) 2 principles 3Tools ( Ishkawa, FMEA, and PHA) 4 main elements in process ( assessment, control, communication, review,) * Summarize today’s key points” ” and orally quiz trainees to make sure they are clear. 1 simplified formula risk=P*S (concepts of quality risk management, risk, h