General Session | Drugs and Medical Devices Sessions | Food Sessions
General Session
8:30AM
Insights and Global Trends Impacting Food and Medical Products
Presenters
- David Acheson, M.D., President and C.E.O., The Acheson Group LLC – download presentation
Drugs and Medical Devices Session
10:45AM
UDI Implementation
Presenter
- Cornelia B. Rooks, Senior Compliance Specialist, Registrar Corp – download presentation
11:15AM
Contract Manufacturing Arrangements for Drugs: Quality Agreements
Presenter
- Paula Katz, Acting Branch Chief, Regulatory Policy and Collaboration, Office of Manufacturing and Product Quality – download presentation
2:15PM
Medical Devices: Reports of Corrections and Removals
Presenter
- Zena Kaufman, Senior Vice President, Global Quality, Hospira – download presentation
3:30PM
Compounding Pharmacies
Presenters
- Erika Butler, Drug Specialist, U.S. Food and Drug Administration – download presentation
- Susan Laska, Acting Deputy Director, Office of Medical Products and Tobacco Operations – download presentation
- Shan Chikhale, Professor of Pharmaceutical Sciences, School of Pharmacy, South College – download presentation
3:30PM
Getting Ready for the Drug Supply Chain Security Act
Presenter
- Ilisa Bernstein, Pharm.D., J.D., Office of Compliance, FDA/CDER – download presentation
Food Session
10:30AM
Integrated Food Safety System and FDA’s Office of Partnerships
Presenter
- Barbara Cassens, Senior Advisor/Acting Director, FDA/ORA/OP – download presentation
11:00AM
The Emerging Risks of a Global Food System
Presenter
- Richard L. Shanks, ARM, National Managing Director, Aon Risk Solutions – download presentation
1:30AM
Enhancing your Organizational Effectiveness – Change Management Principles & Practices
Presenter
- Richard A. Versen, Team Lead, Lean Program, Encana Oil & Gas – download presentation
1:30PM
Role of Environmental Monitoring and Industry Data Review and Decision Making Criteria & Actions
Presenters
- Carrie Rigdon, Rapid Response Team Supervisor, Minnesota Department of Agriculture – download presentation
- Nancy Schmidt, Compliance Officer, U.S. Food and Drug Administration – download presentation
- Scott Hood, Director of Food Safety, General Mills – download presentation
- Warren Stone, Sr. Director of Science Policy, Compliance & Inspection, Grocery Manufacturers Association – download presentation
3:30PM
Consumer Expectations About FSMA Implementation and Impact
Presenter
- Sandra Eskin, Director, Food Safety, The Pew Charitable Trusts – download presentation
3:30PM
Antibiotics in Agriculture and the Campaign on Human Health and Industrial Farming
Presenter
- Gail Hansen, Senior Officer, Human Health and Industrial Farming, The Pew Charitable Trusts – download presentation
3:30PM
Food Allergen Policy Issues
Presenter
- Nicole Smith, Vice President of Government Relations, FAACT – Food Allergy and Anaphylaxis Connections Team – download presentation
3:30PM
Understanding and Managing Mycotoxins in Food and Feed
Presenters
