Course "Applying the FDA Food Safety Modernization Act (FSMA) to Your Organization" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Course Description:

This seminar will highlight the basics of food safety and emphasize food safety and compliance responsibilities as well. It 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, this seminar will train participants on building a program that is resilient and agile in this fast paced environment. This program will include sessions that focus on how an organization can improve their documentation and ensure they are “audit ready” for third party certifiers or government regulators. A practical training segment will allow participants to learn how to identify and assess risks, calculate the applicable risk tolerances, and offer other tips and tools to apply risk management principles within an organization.

Learning Objectives:

Key goals of the seminar will include learning:

  • Overview of the Food Safety and Modernization Act (FSMA)
  • 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
  • Practical tips and tools for applying the training to your individual organization

Who Will Benefit:

The seminar will benefit Senior executives, directors, managers and those with the responsibility of implementing and managing compliance activities, as well as those that have key collateral roles:

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

Topic Background:

The FDA Food Safety Modernization Act (FSMA) grants sweeping new powers to the FDA that must be addressed in an organization’s compliance program. FDA now has a legislative mandate that requires comprehensive, science-based preventive controls across the food supply industry. The 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 has been established. Organizations must understand how these changes affect the way they need to address compliance requirements around food safety.

Course Outline:

Day One (8:30 AM – 4:30 PM) Day Two (8:30 AM – 4:30 PM)

Registration Process: 8:30 AM – 9:00 AM

Session Start Time: 9:00 AM

  1. Understanding the Basics
    • What is the Food Safety and Modernization Act (FSMA)
    • Business Context Leading to the Regulatory Change
    • FSMA Applicability
  2. A Framework to Address Compliance
    • What is OCEG?
    • GRC Capability Framework
    • Applying the GRC Capability Framework to an Organization’s Compliance Program
  3. Hazard Analysis and Critical Control Points
    • HACCP Basics
    • How Does HACCP Relate to FSMA?
    • A Proactive Approach

  1. Farm-to-Table Concept
  2. Assurance
    • Internal Assurance
    • Third Party Certifications
    • Documentation
    • Audit Readiness
  3. Applying Concepts to Your Organization. Monitoring Changes to the Business Context Tools on Implementation.

Meet Your Instructor

Karl M. Nobert
Food and Drug Regulatory Attorney, The Nobert Group LLC

Karl M. Nobert is a food and drug regulatory attorney with the Nobert Group LLC. Mr. Nobert provides regulatory advice and counseling to both large and small domestic and international pharmaceutical companies on regulatory issues related to the U.S. Food and Drug Administration’s review and approval of new drug products. This includes counseling clients on FDA’s regulation of prescription branded and generic drugs, and over-the-counter drug products. He also has considerable experience related to the regulation of biologics including cellular and genetic therapies, and veterinary drug products. He frequently presents and has published on such topics.

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Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund — less a $200 administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days before the start date of the event.

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