By now it is clear to most people working in regulated industries that risk-based decision making is an FDA requirement. It is necessary to incorporate risk management into daily company activities in pursuit of developing a true Quality Risk Management system.  This holistic system is responsible for the identification, analysis, and evaluation of individual risks as well as control and communication of these risks throughout the organization.

By now it is also clear to most people involved in regulated industries that there is a tool called the Failure Mode and Effects Analysis, or FMEA. Use of the FMEA tool helps organizations identify what could go wrong with their processes, the resulting effects, the potential causes, and what controls are in place to prevent or detect them. After this, the organization can identify actions to mitigate the most significant risks. This webinar will demonstrate for participants the development of each of the items listed above and provide real-world examples to show the power of this important tool used as an approach to risk assessment and mitigation.