Senior Director, MedTech Quality Strategy Veeva Systems
Historically, quality has been treated as a cost center - a function meant to monitor adherence to minimum requirements without which a product will not (or should not) make it to market. Quality has become synonymous with compliance - maintaining compliance to regulations to pass inspections, nothing more. However, regulatory trends, public expectations, and visionary thinkers are coming together to cause a shift from a compliance culture (reactive) to a true quality culture (proactive). And those who can successfully transition to a proactive quality strategy are rewarded with a leveling up of quality from a cost center to a value-generating function.
The key element of a successful proactive approach is the detailed identification, assessment, and mitigation of risks - thereby eliminating potential quality issues before they occur. Interconnecting risk management with quality management processes provides a holistic view of quality for faster and more effective allocation of resources and improved efficiencies across products and processes.
Join us to discuss use cases and opportunities to embrace a proactive quality strategy through the unification of quality and risk management.
Learning Objectives:
Upon completion, participant will learn how to drive business value from unified quality and risk management
Upon completion, participant will be able to pursue a holistic approach to QRM through a single unified platform for quality management processes
Upon completion, participant can contribute to the collaboration between industry and tech to drive the improvement and standardization of risk management concepts and methodologies