FDA Enforcement and Your Compliance Program

Why Should You Attend:

The FDA Food Safety Modernization Act (FSMA) grants sweeping new powers to the FDA that must be addressed in your company’s compliance program. FDA now has a legislative mandate to require comprehensive, science-based preventive controls across the food supply. You must understand how these changes affect the way your company needs to address compliance requirements around food safety.

This training will provide the basic building blocks you will need to adjust your company’s governance, risk management and compliance program related to new FDA requirements. With new rule making eminent, we will discuss how your company can build a program that is resilient and agile in this fast paced environment. We will discuss a framework companies can use to stay resilient and agile, how they can improve their documentation and ensure they are “audit ready” for third party certifiers, or government regulators. The session will also highlight some of the recent rule making and enforcement actions by the FDA.

All functional groups who have food safety and compliance responsibility or need to understand the basics of food safety and must be informed about its compliance will benefit from the information shared in this webinar.

Areas Covered in this Webinar:

• Overview of the Food Safety and Modernization Act.
• A Framework to Address Compliance.
• Hazard Analysis and Critical Control Points (HACCP).
• The Farm-to-Table Chain.
• Accredited Third Party Certification.
• Documentation and Audit Readiness.
• Monitoring Changes to the Business Context.

Who Will Benefit:

• Internal Auditors
• Quality Assurance Managers
• Regulatory Affairs
• Operations Managers
• Compliance Professionals
• Risk Management
• Attorneys and Legal Staff

Instructor Profile:

Jason Mefford, is a sought after adviser and speaker on ethics, corporate governance, GRC, and internal audit topics. He is currently the President of Mefford Associates, a professional training, coaching and boutique advisory firm. He has been the chief audit executive at two different multibillion dollar manufacturing companies. Prior to that, he was a manager at two different large public accounting firms, performing internal and external audits and advisory services for clients in various industries. He is also a Fellow with the Open Compliance and Ethics Group (OCEG) a non-profit think tank that uniquely helps organizations drive Principled Performance® by enhancing corporate culture and integrating governance, risk management, and compliance processes.

Topic Background:

The FDA Food Safety Modernization Act (FSMA) mandates that all processing facilities implement preventive controls that are appropriate for their operations. FDA has previously required HACCP (Hazard Analysis and Critical Control Points) for seafood and juice processors, as has USDA for meat and poultry, but FSMA makes HACCP-type preventive controls the norm in all food processing facilities. This new law is historic, because for the first time more than 70 years, a significant overhaul of the statutory tool kit for combating food-borne illness. This act provides the most dramatic changes to food safety regulations affecting food producers and manufacturer in over 70 years.

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