General Sessions | Food Breakouts | Retail Breakouts | Drug & Medical Device
General Sessions
8:15 am – 8:45 am
Public Health Crisis of Opioid Addiction
Presenters
- Mark Levine, MD, Commissioner, Vermont Department of Health
8:45 am – 9:15 am
Children with Intractable Seizures: The History of Cannabidiol and GW Pharmaceuticals
Presenters
- Alice Mead, Vice President of US Public Policy and Public Affairs for GW Pharma, Greenwich Biosciences
9:15 am – 10:15 am
Data Integrity
Presenters
- Mike Chappell, Principal, Regulatory Compliance, Greenleaf Health LLC
- Download presentation by Mike Chappell
11:00 am – 12:00 pm
Why??
Presenters
- Erik W. Coleman, MPH, Health Scientist (Informatics), National Center for Environmental Health, Centers for Disease Control and Prevention, U.S. Department of Health and Human Services
- Carol Conroy, Associate, Safe Food Project, The Pew Charitable Trusts
- Carla Tuite, MS, LCDR, US Public Health Service, Human and Animal Food Policy Branch, Office of Strategic Planning and Operational Policy, ORA, U.S. Food and Drug Administration
Food Breakouts
1:30 pm – 2:00 pm
Moving Towards a Public Health Systems Approach
Presenters
- Joann Givens, Director, Office of Human and Animal Food Operations, U.S. Food and Drug Administration
- Download presentation by Joann Givens
2:00 pm – 3:00 pm
A Conversation with the Experts on Produce Safety
Presenters
- Samir Assar, Ph.D., Director of the Office of Produce Safety, CFSAN, U.S. Food and Drug Administration
- Elizabeth Bihn, Ph.D., Director, Produce Safety Alliance, Cornell University
- Kristin Esch, Produce Specialist, Michigan Dept. of Agriculture and Rural Development
- Joseph Reardon, Assistant Commissioner of Consumer Protection, North Carolina Depart of Agriculture and Consumer Services
3:30 pm – 4:15 pm
FSMA Imports and Systems Recognition
Presenters
- Sharon Mayl, Senior Advisor for Policy, U.S. Food and Drug Administration
4:15 pm – 5:30 pm
Preventive Controls: Moving Food Safety into the 21st Century
Presenters
- Matthew Coleman, Environmental Administrator, Florida Department of Agriculture and Consumer Services
- Joann Givens, Director, Office of Human and Animal Food Operations, U.S. Food and Drug Administration
- Jan Kelly, Manufactured Food Program Manager, Minnesota Department of Agriculture
- Kristen Spotz, Senior Manager, Food Safety and QY Manager, Grocery Manufacturers Association
Retail Breakouts
1:30 pm – 3:30 pm
The Culture of Change….How to get better at getting better.
Presenters
- Benjamin Chapman, Ph.D., Associate Professor, Food Safety Specialist, Department of Agricultural and Human Sciences, North Carolina State University
3:30 pm – 5:30 pm
Alexa, Bring Me Dinner
Presenters
- Dr. John M. Ryan, Ph.D. PCQI, Ryan Systems, Inc
- Christina Bongo-Box, Little Caesars Enterprises, Inc, Co-Chair of the Conference for Food Protection Mail Order Food Safety Committee
- Valerie Madamba, Food Regulatory Counsel, Blue Apron, LLC
- Cory Hedman, VP, Food Safety & Quality Assurance, Meijer, Inc.
Drug & Medical Device
10:30 am – 11:00 am
Health Canada’s Role in the Management of Drug Shortages
Presenters
- Linsey Hollett, Director, Health Product Compliance and Risk Management, Health Canada
- Download presentation by Linsey Hollett
11:00 am – 12:00 pm
ISO 13485:2016 – Starting The Final Countdown
Presenters
- Akie Yamashita, Director, Lead auditor, NSF Medical Devices
- Download presentation by Akie Yamashita
12:00 pm – 1:30 pm
Working Lunch : Handling Regulatory Challenges with Grace Under Pressure
Presenters
- Nancy Singer, President, Compliance-Alliance
- Courtland Imel, CEO, Ceutical Labs
- Daniela Drago, PhD, George Washington School of Medicine and Health Sciences
- Julie Larsen, Senior Partner, BioTekenica
- Diane Amador-Toro, New Jersey District Director, Pharma Program Division I Director, Office of Regulatory Affairs, U.S. Food & Drug Administration
- Adam E. Saltman, M.D., Ph.D. Medical Officer, Center for Devices and Radiological Health, Office of Compliance, U.S. Food and Drug Administration
1:30 pm – 2:15 pm
Aligning Hygienic Design Requirements with Inspections
Presenters
- Angela Anandappa Ph.D., Director, Alliance for Advanced Sanitation, University of Nebraska-Lincoln
2:15 pm – 3:30 pm
Quality System and Design Controls for Combination Products
Presenters
- M. Isabel Tejero del Rio, MD PhD, Center for Devices and Radiological Health, Office of Compliance, U.S. Food and Drug Administration
- Download presentation by M. Isabel Tejero del Rio
3:30 pm – 4:15 pm
Using Benefit Risk in Making Post Market Decisions
Presenters
- Adam E. Saltman, M.D., Ph.D. Medical Officer, Office of Compliance, Center for Devices and Radiological Health, U.S. Food and Drug Administration
- Download presentation by Adam E. Saltman
4:15 pm – 5:00 pm
Compliance Questions Panel
Presenters
- Diane Amador-Toro, New Jersey District Director, Pharma Program Division I Director, Office of Regulatory Affairs, U.S. Food & Drug Administration
- Mark Bailey, Supervisor, Medical Devices Inspection Program, Health Canada
- M. Isabel Tejero del Rio, MD PhD, Center for Devices and Radiological Health, Office of Compliance, U.S. Food and Drug Administration
