FSMA PC Rule Readiness | Systems Thinking: What is it? May 25, 2015

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PC Readiness Training

May 25, 2015

Event Title
Systems Thinking: What is it?

Systems thinking is an approach to problem solving, by viewing "problems" as parts of an overall system, rather than reacting to specific parts, outcomes or events, and thereby potentially contributing to further development of unintended consequences. Systems thinking is not one thing but a set of habits or practices within a framework that is based on the belief that the component parts of a system can best be understood in the context of relationships with each other and with other systems, rather than in isolation. Systems thinking focuses on cyclical rather than linear cause and effect.

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Speaker Information

Ryan Brown, Global Supplier Quality Assurance Leader, Cargill Animal Nutrition

Ryan Brown

Ryan Brown is the Global Supplier Quality Assurance Lead for Cargill Animal Nutrition responsible for its global supplier and external manufacturer food safety, quality and regulatory evaluation and qualification program.  In this role, he oversees a team of professionals worldwide responsible for over 10,000 suppliers and over 300 external manufacturers in 66 countries.  He is part of the Cargill Animal Nutrition food safety, quality and regulatory leadership team.  Ryan is the lead trainer for the internal auditor program, mentor new auditors and train and coach employees on the internal policy manual.  He is also part of the FSMA implementation team for Cargill.   

Ryan has been with Cargill for 12 years working in Ohio, Kansas, California and Minnesota.  His work takes him to Cargill locations globally working with internal and external stakeholders.  He has a B.S. in Business from Iowa State University and a M.B.A. from the University of Phoenix.  Ryan is currently working on a M.S. in Food Safety from Michigan State University. 


Joe Levitt, Partner, Hogan Lovells US LLP & Former CFSAN Center Director

Joe Levitt

Joe Levitt is a 25-year veteran of the FDA with six years as Director of the Center for Food Safety and Applied Nutrition (CFSAN). Joe currently counsels numerous food companies and trade associations in food safety, labeling and compliance matters, and how to work effectively with the FDA, as well as on regulatory aspects of Federal, state and private litigation. He is particularly accomplished in helping companies that face significant compliance challenges with the FDA.

Joe has received numerous honors and awards in both the public and private sectors: Top Tier ranking from Chambers USA for Food and Beverage lawyer, BTI All-Star for excellence in client service, three Presidential Executive Rank Awards, the HHS Distinguished Service Award, and more.

He received his B.A .from Cornell University and J.D. degree from Boston University School of Law. Joe also has superb knowledge of the FDA Food Safety Modernization Act, including all phases of its development and implementation.


Dave Cook, Director of Global Auditing, Corrective & Preventive Action, Kraft Foods Group

Dave Cook

Dave Cook is the Global Audit and Corrective and Preventive Action Lead for Kraft Foods responsible for its global supplier, internal and external manufacturing network.  In this role, he oversees a team of internal professionals responsible for identifying opportunities for improvement and ensuring visibility and accountability for corrective action.  He is engaged in third party auditing of its plants and supply base through Global Food Safety Initiative (GFSI). He is part of the food safety, quality and regulatory leadership team in Glenview, IL. 

Dave has been with Kraft Foods for 26 years and has been in food safety and quality leadership roles in each division.  He has worked in Regulatory Compliance, Sanitation, Policy, and Special Situations Management.   Dave has a B.S. in Food Science from Cornell University and an MBA from Lake Forest Graduate School of Management.


Roberta Wagner, Co-chair, FSMA Phase 2 Steering Committee

Roberta Wagner

Roberta Wagner has been with the FDA for more than 28 years, 22 years in the Office of Regulatory Affairs (ORA) and almost seven years in CFSAN. Before re-joining CFSAN as Director, Office of Compliance (OC), she was Assistant Commissioner for Operations in ORA. Prior to assuming leadership positions in the Center's OC, she was the Director of the Division of Communication and Education.

Roberta earned her B.S. in Biological Science with a minor in Environmental Science from Hiram College and an M.S. in Biochemistry from Bowling Green State University. Following graduate school, she was employed briefly at Johns Hopkins Hospital as a Research Assistant in the Oncology Department.


Ernest Julian, Chief, Office of Food Protection, Rhode Island Department of Health

Ernest Julian

Ernest Julian, Ph.D. has served as Chief of the Office of Food Protection for the Rhode Island Department of Health for the last 25 years.  Prior to this, he was with the Connecticut Department of Health for 14 years.  He serves on the FDA Preventive Control Workgroup developing the implementation plan for this new regulation. Ernest has served as Chair of the Council of Public Health Consultants for NSF International, President of the Northeast Food and Drug Officials Association, and he serves on the Council to Improve Foodborne Outbreak Response (CIFOR).  He also serves as lead instructor for Louisiana State University’s “A Coordinated Response to Food Emergencies” course dealing with foodborne outbreak investigations.  His Masters and Ph.D. work in Adult Education focused on obtaining behavioral and system changes to improve food safety.

Ernest is a recipient of the FDA Commissioner’s Special Citation, the CDC & ATSDR Honor Award, the Northeast Association of Food and Drug Officials Eaton Smith Award, the AFDO President’s Award, and the Wiley Award.







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