Join regulatory colleagues from across the Wisconsin area for a briefing by senior officials of the US Food and Drug Administration’s (FDA) Office of Regulatory Affairs (ORA, FDA’s field organization) about the latest agency initiatives and the most effective strategies for working with the Minneapolis District Office (MIN-DO). This premier event is sponsored by the RAPS Wisconsin Chapter and is intended to facilitate the exchange of ideas among local regulatory professionals.

This event will provide an opportunity for local regulatory professionals to interact directly with senior FDA regulators. The program will include a presentation from Melinda K. Plaisier, regional food and drug director, Central Region, of ORA about the latest FDA initiatives. Additionally, participants will hear from FDA’s Minneapolis District experts, Rhonda Mecl and Timothy Philips, about the most effective strategies for working with the MIN-DO. The following topics will be covered, followed by open discussion and a questions and answer period.ORA

Overview

Roles and responsibilities of ORA Headquarters, Regions, Districts, Resident PostsMIN-DO operationsCurrent FDA/ORA initiatives/prioritiesOverview of FDA inspections and compliance programsCommunicating with the MIN-DO and resident posts: how/when to communicate and with whomBest practices for working with the MIN-DO on product recallsMost common triggers for medical device and drug observations and Warning Letters

• Melinda K. Plaisier, regional food and drug director, central region, Food and Drug Administration, Office of Regulatory Affairs
• Rhonda L. Merl, supervisory consumer safety officer, FDA Minneapolis District Office
• Timothy Philips, consumer safety officer, FDA Minneapolis District Office

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