Presentations

Page revised: Monday, July 21, 2014

Sunday, June 22, 2014

8:00AM - Global Communication, Coordination, Collaboration, Education, & Training - William Krueger, President, CCCET Solutions

8:00AM - Proposed Rule to Protect Food Against Intentional Adulteration - LeeAnne Jackson, Health Science Policy Advisor, FDA

8:00AM - Combined Effect: Enhancing Food Defense Strategies through Integration of Food Safety Practices at the State and Local Level - Gary W. Elliott, MA, REHS, South Carolina Department of Health and Environmental Control

8:00AM - Food Protection and Defense Committee - Partners in Defending the Food Supply - Erika Nelson, COO/Managing Director, National Center for Food Protection and Defense

9:30AM - Trends in State Laws Related to Food - Doug Farquhar, Program Director for Environmental Health, National Conference of State Legislatures

1:00PM - Food Committee - FDA Preventive Control Regulation - Ernest Julian, Ph.D., Chief, Office of Food Protection, RI Department of Health

1:00PM - Food Committee - Retail Update - Alan Tart, Retail Food Program Specialist, FDA/ORA/OP

2:00PM - International & Government Relations Committee - Ricardo Cavazos Cepeda, Director General De Estudios Economicos, COFEPRIS

Monday, June 23, 2014

General Session

8:30AM - Insights and Global Trends Impacting Food and Medical Products - David Acheson, M.D., President and C.E.O., The Acheson Group LLC

Drugs and Medal Devices Session

10:45AM - UDI Implementation - Cornelia B. Rooks, Senior Compliance Specialist, Registrar Corp

11:15AM - Contract Manufacturing Arrangements for Drugs: Quality Agreements - Paula Katz, Acting Branch Chief, Regulatory Policy and Collaboration, Office of Manufacturing and Product Quality

2:15PM - Medical Devices: Reports of Corrections and Removals - Zena Kaufman, Senior Vice President, Global Quality, Hospira

3:30PM - Compounding Pharmacies - Erika Butler, Drug Specialist, U.S. Food and Drug Administration

3:30PM - Compounding Pharmacies - Susan Laska, Acting Deputy Director, Office of Medical Products and Tobacco Operations

3:30PM - Compounding Pharmacies - Shan Chikhale, Professor of Pharmaceutical Sciences, School of Pharmacy, South College

3:30PM - Getting Ready for the Drug Supply Chain Security Act - Ilisa Bernstein, Pharm.D., J.D., Office of Compliance, FDA/CDER

Food Session

10:30AM - Integrated Food Safety System and FDA's Office of Partnerships - Barbara Cassens, Senior Advisor/Acting Director, FDA/ORA/OP

11:00AM - The Emerging Risks of a Global Food System - Richard L. Shanks, ARM, National Managing Director, Aon Risk Solutions

1:30AM - Enhancing your Organizational Effectiveness – Change Management Principles & Practices - Richard A. Versen, Team Lead, Lean Program, Encana Oil & Gas

1:30PM - Role of Environmental Monitoring and Industry Data Review and Decision Making Criteria & Actions - Carrie Rigdon, Rapid Response Team Supervisor, Minnesota Department of Agriculture

1:30PM - Role of Environmental Monitoring and Industry Data Review and Decision Making Criteria & Actions - Nancy Schmidt, Compliance Officer, U.S. Food and Drug Administration

1:30PM - Role of Environmental Monitoring and Industry Data Review and Decision Making Criteria & Actions - Scott Hood, Director of Food Safety, General Mills

1:30PM - Role of Environmental Monitoring and Industry Data Review and Decision Making Criteria & Actions - Warren Stone, Sr. Director of Science Policy, Compliance & Inspection, Grocery Manufacturers Association

3:30PM - Consumer Expectations About FSMA Implementation and Impact - Sandra Eskin, Director, Food Safety, The Pew Charitable Trusts

3:30PM - Antibiotics in Agriculture and the Campaign on Human Health and Industrial Farming - Gail Hansen, Senior Officer, Human Health and Industrial Farming, The Pew Charitable Trusts

3:30PM - Food Allergen Policy Issues - Nicole Smith, Vice President of Government Relations, FAACT – Food Allergy and Anaphylaxis Connections Team

3:30PM - Understanding and Managing Mycotoxins in Food and Feed - Dr. Michael Henry, Animal Scientist, U.S. Food and Drug Administration Center for Veterinary Medicine (CVM), Division of Animal Feeds

3:30PM - Understanding and Managing Mycotoxins in Food and Feed - Dr. Tim Herrman, State Chemist and Director of the Office of the Texas State Chemist, Texas A & M University System 

Tuesday, June 24, 2014

Drug and Medical Device Session

10:30AM - Comparing the U.S. and European System for Regulating Medical Devices - Paul Brooks, Senior Vice President, Healthcare Solutions, BSI Americas

11:15AM - Case for Quality Initiative Update - Ricky Rodriguez, Dallas District Director, FDA and Steve Silverman, Director, Office of Compliance, FDA

1:30PM - "Establishing Retail Food Safety Policy" - The Federal, State, and Local perspective, including the outcomes from the 2014 Conference for Food Protection (CFP) - Kevin Smith, FDA; Therese Pilonetti, CO Dept of Public Health; Monique Mull, Mesa County Health Dept

2:15PM - Metric, Data and Analysis, and Biometrics - Ricki Chase, Director of Investigations, FDA

3:30PM - Pharmaceutical Inspection Co-Operation Scheme - Susan Laska, Acting Deputy Director, Office of Medical Products and Tobacco Operations

3:30PM - Data and Decisions/Actions Based on Common Deficiencies from State Agencies - Natalie Adan, GA Dept of Agriculture

Food Sessions

8:30AM - FDA – Progress, Trends, and Compliance - Ellen Morrison, Assistant Commissioner for Operations, U.S. Food and Drug Administration/Office of Regulatory Affairs 

11:00AM - USDA – Progress, Trends and Compliance - Jerry L. Elliott DVM, Director – Compliance and Investigations Division, USDA

11:30AM - Funding Opportunities for State, Local, Tribal, and Territorial Retail Food Regulatory Programs - Cathy Hosman, Grant Project Office, Office of Partnerships,  U.S. Food and Drug Administration - Pete Salsbury, Project Manager, U.S. Food and Drug Administration

1:30PM - “Improving Behaviors on the Front Line”  - FDA’s Partnership with Google to Test the Effectiveness of Oral Culture Learner Project Materials - Chuck Catlin, Global Food Program Quality Assurance and Risk Manager, Google -Alan Tart, Retail Food Program Specialist, U.S. Food and Drug Administration 

1:30PM - “Are things getting better?” Overview of FDA’s  Retail Risk Factor Study and  the Promotion of Active Managerial Control - Mario Seminara, R.S., Regional Retail Food Specialist, U.S. Food and Drug Administration/Office of Regulatory Affairs 

1:30PM - “Are things getting better?” Overview of FDA’s  Retail Risk Factor Study and  the Promotion of Active Managerial Control - Lane Drager, Consumer Protection Coordinator, Boulder County Public Health, Environmental Health Division

1:30PM - Quality Laboratory Results, Kristen Durie, Chemistry Quality Assurance Officer, NY State Department of Agriculture and Markets

1:30PM - Methods Development - Robert Sheridan, Chemistry Program Manager, NY State Department of Agriculture and Markets

1:30PM - Update on Sampling Agreements - Michelle Motsinger, Consumer Safety Officer, FDA

3:30PM - Customs and Border Protection – Objective and interfaces with other agencies to prevent the illegal entry of agricultural and food products while facilitating trade - Brenda Smith, Executive Director, Office of International Trade, US Customs and Border Protection

3:30PM - FDA International Programs – Objectives, areas of focus, key organizations and outcomes - Cathleen McInerney Barnes, International Policy Analyst, U.S. Food and Drug Administration 

3:30PM - Industry Examples of Common Challenges & Deficiencies - Karl Thorson, Manager, Sanitation Center of Excellence, General Mills

3:30PM - Wet & Dry Principles & Practices - Warren Stone, Sr. Director of Science Policy, Compliance & Inspection, Grocery Manufacturers Association

3:30PM - Global Regulatory Competencies, Curricula, and Capacity Building - Jerry Wojtala, Executive Director, International Food Protection Training Institute

Wednesday, June 25, 2014

Food Session

8:30AM - Charles Ramsey - Defensible Food Safety Decisions in an Uncertain World: The Role of Sampling in Food Safety Decision-Making

8:30AM - Training and Assessment in the 21st Century Workplace: Demonstrating the Ability to Do - Dr. Will Dardick, GWU; Dr. Bateson, FDA; Dr. Craig Kaml, IFPTI

8:30AM - Mentoring Training - Cathy Johnson, APHL