FSMA Update Webinar--Focused Mitigation Strategies to Protect Food Against Intentional Adulteration

Presenters


Joseph A. Levitt
Partner
Hogan Lovells US LLP
Washington, DC



Joseph Levitt is a 25-year veteran of the U.S. Food and Drug Administration (FDA). He focuses on the development and implementation of legislative and regulatory policy regarding the manufacture and marketing of food, drugs and medical devices and how to work effectively with the FDA and related agencies. Joe also brings in-depth knowledge to a wide range of matters, including food and drug safety, biotechnology, labeling, advertising, and bioterrorism.

For six years, from February 1998 through December 2003, Joe served as Director of the FDA's Center for Food Safety and Applied Nutrition (CFSAN), where he led successful efforts to modernize food safety regulation and enhance the security of the U.S. food supply. He also initiated a revitalization of FDA's nutrition program. During his FDA tenure, Joe also helped streamline the new drug review process and launch the agency's food labeling initiative. Additionally, he served as Deputy Director for Regulations and Policy at the FDA's Center for Devices and Radiological Health. He began his FDA career in the Office of Chief Counsel.

Since joining Hogan & Hartson in January 2004, Joe counsels numerous food, drug and device companies and trade associations regarding compliance with federal laws and regulations. Joe has been directly engaged in all phases of the Food Safety Modernization Act, from development through implementation.

 

Elizabeth B. Fawell
Associate
Hogan Lovells US LLP
Washington, DC


Elizabeth Fawell practices in the area of food and agriculture law with specific focus on the regulation of foods, dietary supplements and consumer products, as well as advertising and promotion issues. She represents clients regulated by the Food and Drug Administration, Department of Agriculture, Federal Trade Commission, Consumer Product Safety Commission and other health and safety regulatory agencies at both the federal and state levels.

Prior to joining Hogan & Hartson, Elizabeth was a legislative assistant with the Office of Congresswoman Anne M. Northup. Previously, she was an English teacher with Foshan Yi Zhong Xue.

 

Warren Stone
Senior Director of Science Policy, Compliance and Inspection
Grocery Manufacturers Association
Washington, DC


Warren Stone works with a broad audience including member and potential member companies, GMA scientific and technical staff, regulatory agents and universities and provides GMA members with training, technical guidance, advice and assistance in areas of food safety, food microbiology, HACCP, allergen control, regulatory compliance, food defense, GMPs, quality programs and sanitation systems. Mr. Stone is an instructor for GMA’s various HACCP course offerings and Better Process Control School and serves as staff liaison for GMA’s Food Defense Committee and Sanitary Design Working Group. He currently serves as acting staff liaison for the Microbiological Safety Committee. Mr. Stone also speaks Spanish.

Mr. Stone has 30 years of in-plant experience in both manufacturing and quality assurance in a variety of operations, including low-acid canned foods, frozen foods, meat and poultry, seafood, juice, dairy items, fresh produce, salsas, dips and spreads. He has written numerous HACCP, quality system, sanitation and microbiological control programs for various food companies. Prior to joining GMA, he headed his own consulting firm to provide technical expertise in manufacturing and quality systems, GMPs, sanitary design and HACCP to food industry clients. He holds both a Master's degree from Canisius College of Buffalo, NY and a Bachelor of Science from the University of California at Davis.
 

  Shannon Cooksey
  Senior Director, Science Program Management
  Grocery Manufacturers Association
  Washington, DC

 

 

Shannon (Shana) Cooksey is the Senior Director of Science Program Management at the Grocery Manufacturers Association (GMA), Washington, D.C., representing the world’s leading food, beverage, and consumer products companies.  Shana is a globally recognized project manager, matching cutting edge science to food policy issues, and delivering expert scientific and technical assistance to the food and consumer product goods industry.  At GMA, Mrs. Cooksey oversees all scientific program management activities, including managing all aspects of implementation of the Food Safety Modernization Act (FSMA).  In addition, she has also served as an active project leader for the APEC-PTIN work, staff lead for two Codex Committees, and staff liaison for the Allergen Committee, Economic Adulterations Working Group, Food Industry Analytical Chemists Committee and Beverages Committee.   Prior to her role as Senior Director, she supervised all laboratory operations and co-managed over 20 scientists and professional technical staff in the disciplines of chemistry, biochemistry, microbiology, processing technologies, and packaging and product forensics.  

Mrs. Cooksey holds Master of Science degree in Bio-Inorganic Chemistry from the University of New Mexico and a Bachelor of Arts in Chemistry and Biology from the University of Northern Colorado.  She is a certified Project Management Professional (PMP), holds top certification in Microsoft Project, and is a professional Lean Six Sigma leader (green belt).


Ryan Newkirk, Ph.D., MPH
Policy Analyst
Food Defense and Emergency Coordination Staff
Center for Food Safety and Applied Nutrition
Food and Drug Administration


Ryan Newkirk, PhD, MPH, is a member the Food Defense and Emergency Coordination Staff at the Center for Food Safety and Applied Nutrition(CFSAN) of the US Food and Drug Administration (FDA).  In this position, Dr. Newkirk serves as a member of the Food Safety Modernization Act (FSMA) intentional adulteration working group and played a key role in the development of the IA proposed rule.  In addition, Dr. Newkirk has provided significant contributions to efforts related to economically motivated adulteration, and planned and conducted several food defense awareness workshops. 

Prior to joining FDA, Dr. Newkirk held a post-doctoral position with United States Department of Agriculture, Food Safety and Inspection Service, Food Defense Assessment Staff where he focused on food defense vulnerability assessments and education and outreach.  Dr. Newkirk completed his doctorate in epidemiology and food defense research at the National Center for Food Protection and Defense and the University of Minnesota School of Public Health.  Dr. Newkirk has also completed an MPH degree at Saint Louis University.