FDA's Changing Culture: What It Means for Your Next FDA Inspection

Guest Speaker: Joe Levitt, Partner, Hogan Lovells is a 25-year veteran of the U.S. Food and Drug Administration (FDA); he served as Director of FDA’s Center for Food Safety and Applied Nutrition (CFSAN) for six years, from February 1998 through December 2003. Joe counsels numerous food companies and trade associations in food safety, labeling and compliance matters and how to work effectively with the FDA. He is a recognized expert in the Food Safety Modernization Act (FSMA), including all phases of its development and implementation.

While serving as FDA/CFSAN Director, Joe 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 earlier FDA tenure, while in the Office of the Commissioner, Joe 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.

Joe has been consistently ranked in Chamber
s most recently being ranked in the Top Tier of food and beverage lawyers since joining Hogan Lovells. While at FDA, he received numerous honors and awards, including three Presidential Executive Rank Awards. More recently, Joe received the FDA Distinguished Alumni Award. Joe received his bachelor’s degree, magna cum laude, from Cornell University in 1975 and his J.D. degree, cum laude, from Boston University School of Law in 1978.

Shannon Cole, Senior Director, Science Program Management, GMA 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, Ms. Cole oversees all scientific program management activities, including managing implementation of the Food Safety Modernization Act (FSMA).  In addition, she is also an active project leader for the APEC-PTIN work, staff lead for two Codex Committees, the Allergen Committee, the Food Industry Analytical Chemists Committee and the 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.  

Ms. Cole 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).

Glenn Black, Director, Science Operations, Food Protection, GMA provides leadership and direction for research and member services related to food processing and microbiological safety. He co-manages over 20 scientists and professional technical staff in the disciplines of chemistry, biochemistry, microbiology, processing technologies, packaging and product forensics.

Prior to joining GMA, Dr. Black held positions with the Pepsi-Cola Company, the Facility Group (food plant construction), Stork Food & Dairy Systems and Unilever (Slim Fast Foods division). He has published a number of articles in recognized food journals dealing with microbial modeling and inactivation.

Dr. Black earned his B.S. and M.S. in Agricultural Engineering at Clemson University and his Ph.D. in food science from the University of Tennessee.