Preventive Controls

FEMA, in collaboration with the American Spice Trade Association (ASTA), presented Preventive Controls, a FSMA webinar on February 1, 2013.  Click here to access the order form.

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FEMA Member Price:  $155.00
Non-Member Price:  $355.00

 

This proposal, which is a key component of the Food Safety Modernization Act (FSMA), is the most significant food safety development in over 70 years.  All facilities registered with FDA will be required to implement these preventive controls.  That includes facilities located outside the U.S.

Join food safety experts Joe Levitt and Maile Gradison Hermida of Hogan Lovells as they break down the 680 pages of the proposed rule on topics such as:

• Hazard analysis
• Risk based preventive controls
• Monitoring procedures
• Corrective actions
• Verification
• Recordkeeping

They’ll review what you need to know about what the rule says, how it impacts your company, and where to focus attention during the public comment period.  This proposal affects virtually all packaged foods regulated by FDA, so it’s important that all ASTA and FEMA members start getting acquainted with these proposed requirements right away.

Speaker Information

Joseph A.  Levitt, Hogan Lovells

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 indepth 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 Gradison Hermida, Hogan Lovells

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.