Registration and Continental Breakfast
Amy Comstock Rick, President & CEO, FDLI
Stephen M. Ostroff, Deputy Commissioner for Foods and Veterinary Medicine, Office of the Commissioner, FDA
Introduced by Sarah Roller, Partner, Kelley Drye & Warren LLP and Chair, FDLI Food Enforcement and Compliance Conference
Coffee and Networking Break
Part I: Food Safety Enforcement and Compliance
Inspections in the FSMA Environment
How are FDA policies concerning facility inspections evolving with the implementation of the Food Safety Modernization Act (FSMA)? How are inspectors adjusting their practices and procedures in light of the evolution from GMP inspections to full preventive control inspections? What can industry expect with regard to agency requests for records and other procedures during routine inspections versus investigations involving potential food safety risks? How have inspections of foreign facilities changed? What can importers expect with respect to inspections?
Elizabeth Fawell, Partner, Hogan Lovells US LLP
Anthony T. Pavel, Senior Food Lawyer, Cargill, Inc.
Priya Rathnam, Acting Director, Compliance Policy Staff, CFSAN, FDA
Moderated by Mark C. Levy, Member, Eckert Seamans Cherin & Mellott, LLC
11:00 AM–12:00 PM
Investigations of Foodborne Illness Outbreaks: The Growing Role of Environmental Monitoring and Whole Genome Sequencing
This session will examine recent developments in whole genome sequencing technology, how FDA is using this technology and their future plans for its use, and considerations for food companies in developing environmental monitoring programs and using whole genome sequencing.
Karen Blickenstaff, Acting Response Manager, Coordinated Outbreak Response and Evaluation (CORE) Network, FDA
Leslie Hintz, Consumer Safety Officer, Office of Compliance, CFSAN, FDA
Smitha Stansbury, Partner, FDA & Life Sciences Practice, King & Spalding LLP
Moderated by Daniel Dwyer, Partner, Kleinfeld, Kaplan & Becker LLP
Luncheon with Guest Speaker
Eric Brown, Director, Division of Microbiology, Office of Regulatory Science, CFSAN, FDA
Introduced by Laura Brown, Director, Educational Programs, FDLI
Enforcement and Compliance Issues Presented by Dietary Ingredients
In this session, panelists will discuss issues related to dietary ingredients, including new dietary ingredients and FDA’s progress on developing a list of grandfathered ingredients. Panelists will also discuss FDA’s progress on a revised draft guidance for new dietary ingredients, as well as FDA enforcement activity.
Rend Al-Mondhiry, Senior Counsel, Amin Talati Upadhye, LLP
Robert J. Durkin, Deputy Director, Office of Dietary Supplement Programs, CFSAN, FDA
Megan Olsen, Assistant General Counsel, Council for Responsible Nutrition