A Complimentary CLE event from Gardner Law 

Gardner Law invites you to join us on May 22nd from 12:00-3:00pm at landmark beer hall and pizza restaurant Surly Brewing Co. in the heart of the Twin Cities for an in-person or live-streamed webinar. Over the course of five sessions, Gardner's attorneys will present updates and practical insights surrounding emerging enforcement trends, compliance best practices, and recent regulatory challenges impacting FDA-regulated companies. 

Program Schedule:

12pm - 12:30pm - Amanda Johnston will hop to it with What’s Brewing in Compliance? Hot Topics and Enforcement Trends. This session will cover recent Anti-Kickback Statute (AKS) and False Claims Act (FCA) cases and settlements, along with key compliance trends affecting FDA-regulated companies. Attendees will also gain insights into the latest OIG Work Plan priorities and emerging healthcare compliance risks.

12:30pm - 1pm -Next on tap is Nathan Downing's Tapping into FDA: Regulatory Hot Topics. This session will provide updates on the latest with the FDA. Following an engaging presentation and discussion between Nate, Rebecca Zadaka and Brynn Stanley, attendees will gain insight into being proactive in crafting their regulatory approach based on an evolving regulatory landscape.

1pm - 1:30pm - David Graham presents Pour Decisions: Lessons from Health Care Fraud & Liability Cases. This session will discuss important health care fraud and product liability cases and decisions from the last year and outline the DOJ’s and OIG’s enforcement priorities going forward. Attendees should expect to gain insights into enforcement trends and priorities, risk mitigation and compliance strategies to help navigate potential legal pitfalls—all from real life cases.

1:30pm - 1:45pm - Break

1:45pm - 2:15pm - Paul Rothermel will crack open this session with Hot or Cold? A Privacy Enforcement Update. Much like Minnesota temperatures in May, privacy enforcement trends are challenging to plan for. Join us for this information-filled session breaking down key privacy enforcement trends in the U.S. and abroad, including examples and relevant compliance tips. Attendees will leave this session with a stout awareness of enforcement priorities and how to better comply in these critical areas.

2:15 - 3pm - Mark Gardner will serve up last call with a Panel Discussion where attorneys and industry leaders, including Bryan Phillips, Sr. Vice President, General Counsel and Secretary, and Chief Compliance Officer at Inspire Medical Systems, Frank Piskolich, Division General Counsel at ZOLL Medical Corporation, Wendy Cusick, former General Counsel and Compliance Officer at Spineology, and Jonelle Burnham, VP, General Counsel and Compliance Officer at CVRx | Barostim will discuss all the latest topics of the day.

3:00- 4pm - We will close out the afternoon with a networking reception for those attending in person.