OPS AC mtg October 5.ppt

Quality Systems and Risk Management (Q9 Q10) Advisory Committee of the Office of Pharmaceutical Science, Center for Drug Evaluation and Research, USFDA October 5, 2006 Frederick Razzaghi CHPA Agenda Introduction Quality Risk Management Q9 Relation of Q9 to Q10 The guidance Next step Doing what is important(Risk based) Non-science and precedence based Requirements have an accumulative effect. Overwhelm organizations. Organizations can not answer the value question! Highlighted in part by the current period of dwindling resources and demand for faster and better outcomes. Risk based Qual