Introduction to Quality Risk Management (QRM) for Medicinal Products Location: Online Meeting Time: 6.30pm - 8.00pm (EST) PDU's: 1 Technical Join Jon Williams for a basic primer on the fundamentals of QRM in the pharmaceutical industry. The objective is to provide the audience with an understanding of the critical elements of a QRM Program and how it fits into a pharmaceutical quality organization focusing on the following areas: Risk as defined by ICH Q9 (Quality Risk Management) QRM Lifecycle Management Requirements of a QRM programs at a Pharmaceutical manufacturing site Commonly used Risk Tools The Presenter Jon Williams has worked in Quality Risk Management (QRM) for the Sanofi Biologics organization for the past 7 years where he supported manufacturing sites in the implementation and integration of QRM principles throughout the site quality organization including training on formal risk tools (FMEA, HACCP, etc.) and the development of custom risk tools. Jon’s current role is with the Sanofi Global Proactive QRM Program tasked with implementing a proactive QRM Program across the entire Sanofi organization by providing harmonized practices targeted at anticipating and avoiding unacceptable risks based on ICHQ9 (Risk Management) guidelines.