eMDR Business Case Model

How to determine the business case options for eMDR

Webcast Summary:

The FDA will no longer accept paper 3500A MedWatch forms when eMDR becomes law. To comply with the new law, companies will be forced to either manually enter MDRs in the FDA's Webtrader system or use an electronic system such as TrackWise to automatically generate eMDR records.

In addition, the FDA will begin to send 3 acknowledgements to indicate that the file was received; the eMDR is not considered received until all 3 ACKS are successfully received.  Companies that manually file will be required to check FDA's database for the 3 acknowledgements while automated solutions require no additional resources for this task. Although eMDR has been touted as a way to increase efficiencies and decrease risk, that’s really only the case when companies invest in electronic systems to automate the additional steps required to comply with eMDR.

This webcast provides a step-by-step approach to help quantify the benefits, or return of investment of deploying TrackWise to generate eMDR records.  Rather than telling you what your ROI will be, this tool is designed to walk you through the steps - with your own unique scenario and assumptions - to determine the expected benefits for your organization.

Tim Mohn is an Industry Principal in Sparta Systems’ Product Management group.  In this role, Tim is responsible for monitoring changes in the regulatory environment and trends in the life sciences industry.

Tim previously served as Worldwide Quality Systems Manager at Ortho-Clinical Diagnostics, a division of Johnson & Johnson.  At OCD he was part of the TrackWise team for 7 years, and he championed eMDR and SAP integration activities. In addition Tim was the CAPA process owner, and he directly supported multiple FDA inspections at OCD's different locations.  Prior to J&J Tim worked at Pfizer Consumer Healthcare and Wyeth Pharmaceuticals.  Tim has a BS in Biology and a Masters in Manufacturing Management from Penn State.