Designing Training for an Evolving Regulatory Environment

Description: Often, when regulations are revised, those revisions can be communicated out and processes can be updated easily. However, when regulations go through major changes, such as EU MDR, a simple communication isn’t enough, and it can be difficult to navigate all the moving parts of the resulting learning curve. This session will explore a case study of our team’s evaluation of the MDD to EU MDR change, including a walk through of our communication and training strategy and implementation and a review of submission deficiency metrics for continuous improvement. Attendees will learn how our team countered assumptions about regulation changes in order to design effective training and looked beyond the delta to evaluate the impact to the entire product lifecycle. Our team’s strategy for building a foundation-up training program for both regulatory and cross-functional team members will provide a framework that can be applied to any similar training topic, resulting in smoother change implementation and execution.