Program Recap: Turning Plans into Practice

On February 13, 2025, Gardner Law hosted the concluding session of its Healthcare and FDA Compliance in 2025 CLE program, titled "Turning Plans Into Practice." Moderated by Mark Gardner, founder and managing partner of Gardner Law, the distinguished panel featured industry leaders:

• Anne Miller, Senior Strategic Legal Counsel at Medtronic
  
• Stephen Froehle, VP & General Counsel at Coloplast
• Sarah Karlgaard, General Counsel & Secretary at FUJIFILM
• Alex Rosenstein, General Counsel and Compliance Officer at National Marrow Donor Program

The panel focused on critical insights into building effective compliance cultures, strategies for navigating regulatory ambiguity, and practical best practices for employee training and engagement.

For a deeper dive into the insights shared, we invite you to watch the full recording of "Turning Plans Into Practice" on our YouTube channel or visit our website to read more detailed recaps from past events, including this event's two other sessions, FDA War Stories from the Front Lines featuring David Graham and Practical Tips for Improving Your Compliance with Amanda Johnston.

Major Themes

One of the panel's key insights came from Sarah Karlgaard, General Counsel and Secretary at FUJIFILM, who underscored the importance of leveraging real-world challenges to strengthen compliance programs. She advised companies to view compliance crises as learning opportunities, explaining:

“Don’t ever let a crisis go to waste. If something goes wrong, don’t go too far after the case is resolved before you come back and do a retrospective, asking how we could have done it better or differently.”

Anne Miller, Principal Legal Counsel from Medtronic, highlighted the significance of integrating legal expertise closely with quality and regulatory teams, stating,

"It doesn't happen overnight; it's relationship-building and trust-building, learning to be collaborative partners with them."

The panelists also provided valuable advice on managing regulatory ambiguity. Stephen Froehle, Vice President and General Counsel at Coloplast, stressed the necessity of carefully assessing compliance risks and seeking external insights when needed. He suggested utilizing outside counsel to gain perspective on complex regulatory scenarios, helping clarify situations and making informed decisions when navigating "gray areas."

Another critical takeaway was the importance of proactively addressing compliance issues before they escalate. Alex Rosenstein, General Counsel and Chief Compliance Officer from NMDP shared insights into compliance culture, noting that,

"Tone at the top is crucial. As the General Counsel and Compliance Officer, you can't be the only one talking about compliance. It must resonate throughout the entire executive team."

Training effectiveness was another key topic, with Anne Miller pointing out the advantage of frequent, targeted sessions rather than lengthy, infrequent sessions. Alex Rosenstein reinforced this by recommending "smaller, targeted trainings" that resonate more strongly with employees. Gardner and the panelists also advocated for creative and interactive training approaches, including role-play exercises and scenario-based examples to increase retention and engagement.

Looking Ahead

Regulatory environments are expected to remain uncertain, especially with evolving FDA enforcement trends and heightened scrutiny in areas such as data privacy and cybersecurity. The panelists recommended proactive preparedness and vigilance to adapt quickly and effectively to any changes that may emerge from regulatory authorities.

As compliance expectations continue to evolve, Gardner Law remains committed to helping companies navigate these complexities proactively and strategically. Schedule a consult with Gardner Law so we can support your organization's compliance journey in 2025 and beyond.

Resources:

Watch the full recording here.
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