Crisis Averted! Preventing and Managing Disruptive Compliance Challenges
Medical device and diagnostic organizations are often faced with disruptive events that take dedicated leadership to achieve successful outcomes. Warning letters, consent decrees, product recalls, regulatory inspections, and supply chain disruptions require immediate attention, and delays can be costly. In medical technology, these crises have the potential to upend operations, financial metrics, and reputations. Your response can be the difference between mitigation and disaster.
We will talk through best practices to handle disruptive events that may distract your organization from its day-to-day business. The conversation will provide real-world experiences, advice, and strategies to help guide you on the path to minimizing the impact of crises that are inevitable in these industries.
Join us as we explore how to prevent the disruptive events you can and quickly and effectively respond to the ones you can’t.
- Minimizing compliance risks through enhanced organizational approaches (culture, processes, systems)
- Managing compliance issues to prevent business crises
- Managing crisis events when they occur
- Leading remediation programs
- Learning from non-compliance experiences to drive continuous improvement
7:00-7:15 PM | Introductions and announcements
7:15-8:15 PM | Presentation
8:15-8:30 PM | Q&A and sign-off
Date & Time: Monday, November 14 @ 7:00 pm
PDUs: 1.00 - Ways of Working (Technical)
Tim Ehr, Director, IPM
Tim Ehr is a Director in IPM’s Minneapolis office. He brings more than 20 years of experience in the medical device space, including six years as an independent consultant. He has substantial experience with product development, quality, and project management. In his role at IPM, he manages accounts in Minnesota and works with medical device companies across the country, supporting them on a range of quality initiatives from continuous improvement to remediation.
Tim holds a double bachelor’s degree from the University of Wisconsin in Biochemistry and Pre-Med and a bachelor’s degree from the University of Minnesota in Engineering. He also holds a master’s degree from the University of Minnesota in Agriculture. He has a Project Management Professional (PMP) designation from the Project Management Institute (PMI) and is a certified Six Sigma Black Belt.
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