Please find the session links next to their corresponding agenda item.

Thursday, October 12


11:00 AM 

FDLI Welcome and Announcements
Khara L. Minter, Assistant Director, Training Programs, FDLI

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11:05 AM–12:20 PM 



Post Marketing Issues
Lauren Farruggia, Associate, Goodwin Procter LLP

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12:20–12:30 PM 




12:30–1:30 PM 



Manufacturing and Quality System (QS) Regulation
Janet Book, Principal Program Lead Medical Devices, NSF International

Watch this session here.


1:30–1:40 PM



1:40–2:40 PM

Enforcement and Compliance
Brandon J. Moss, Partner, Wiley LLP

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2:40–2:50 PM



2:50–3:50 PM


Promotion and Advertising
Carolina M. Wirth, Of Counsel, Hall, Render, Killian, Health & Lyman P.C.

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3:50–4:00 PM



4:00–5:00 PM


International Issues
Sarah H. Stec, Senior Counsel, Medical Device Regulatory Law, Johnson & Johnson

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CLE Information


This event is pending approval in Ohio. To obtain credit, please email [email protected] at the end of the conference and include your state bar number along with how many credits you wish to obtain. FDLI will certify your attendance for you. An evaluation is required to obtain credit.


This event is pending approval in Virginia. Please email [email protected] to request a Virginia form. You will need to certify your attendance online at Retain the Certificate of Attendance for two years.

Other States

These CLE approvals may also be honored by other states; please check with your bar association for guidance. At the end of the conference, please email [email protected] to receive a certificate of attendance.