FSMA Update Webinar--Know Your Supplier: Foreign Supplier Verification and Third-Party Accreditation

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.


Maile Hermida
Associate
Hogan Lovells US LLP
Washington, DC

 

 

Maile Gradison Hermida practices with Hogan Lovells in the area of food and agriculture law. She represents food companies, including manufacturers, distributors, retailers, and their trade associations. Her clients are regulated by the Food and Drug Administration, Department of Agriculture, Federal Trade Commission, and other health and safety regulatory agencies at both the federal and state levels.


Maile advises clients on the development of label claims, website and promotional campaigns for products, as well as the various requirements applicable to the labeling of foods. She also provides assistance to trade associations and food companies with fashioning comments and developing strategies in response to agency rulemaking and other public policy issues. Her practice is increasingly focused on counseling companies and trade associations as to the implementation of the FDA Food Safety Modernization Act. Maile also assists clients with responses to Federal Trade Commission, Congressional, and state Attorney General investigations and counsels clients on the development, interpretation, and enforcement of laws and regulations governing food production, processing, and distribution.


Prior to joining Hogan & Hartson, she served as a judicial clerk to the Honorable Charles F. Lettow of the U.S. Court of Federal Claims. Maile graduated with high honors from The George Washington University Law School, where she served as executive editor of The George Washington Law Review.


Brian Pendleton, JD
Senior Policy Advisor
Office of the Commissioner, Office of Policy

Food and Drug Administration
Washington, DC

Brian Pendleton is a Senior Policy Advisor in the Office of Policy in FDA’s Office of the Commissioner.  Mr. Pendleton received a B.A. and M.A. in political science from Kent State University and a J.D. from the University of Michigan.  He is a member of the District of Columbia Bar.  Before joining FDA, Mr. Pendleton was an associate at Hyman, Phelps & McNamara, P.C., in Washington, D.C., from 1991-1996.  Mr. Pendleton began his FDA career in November 1996 as a regulatory counsel on the Regulatory Policy Staff in the Center for Drug Evaluation and Research (CDER).  In CDER, Mr. Pendleton worked on numerous drug regulatory matters, including citizen petition responses, guidance documents, and regulations on NDA and ANDA review and approval procedures, current good manufacturing practices, and foreign clinical studies.  In 2009, Mr. Pendleton joined the Office of Policy, where he works primarily on multi-Center rulemakings and guidances.  He currently leads the working groups developing FDA’s regulations on foreign supplier verification programs for food importers and good importing practices for drug importers. 


Charlotte A. Christin, JD, LLM
Senior Policy Advisor
Office of the Commissioner, Office of Policy

Food and Drug Administration
Washington, DC

Ms. Christin is a Senior Policy Advisor in the Office of the Commissioner, Office of Policy, where she focuses on food issues.  Ms. Christin led the team that developed the proposed rule on Accreditation of Third-Party Auditors and is continuing to work on policy and operational issues associated with that new program.  Before coming to the Office of the Commissioner, she served as the Director of Executive Operations in FDA’s Office of Regulatory Affairs and Senior Regulatory Counsel in FDA’s Office of Counterterrorism and Emerging Threats.  She is licensed to practice law in California and Virginia.
 

  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).