FDA Proposed Rule for Additional Traceability

Learn about the FDA’s Proposed Rule for Additional Traceability

This webinar recording gives you an overview of the proposed rule for the food manufacturing supply chain, and how it would impact your company

With the proposed rule, companies will have just 24 hours to provide new traceability records to the FDA when asked, and the records must be in an electronic sortable spreadsheet. This proposed rule is expected to be finalized and go into effect soon (the extended comment period ended in February, 2021), and may be expanded to cover more companies later.

Get a clear understanding of the proposed rule and how it will apply to you with this webinar overview, so that your company can begin planning changes to your processes and recordkeeping.

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    In this webinar, you’ll learn from traceability experts:

    1. The FDA’s goals for the proposed rule and why they’re adding new traceability requirements.
    2. The proposed Food Traceability List of harvested and processed foods covered by the new requirements.
    3. The five supply chain roles that the new requirements apply to (Growers, First Receivers, Transformers, Creators, Shippers) and the impacts to each—and which small companies would be exempt from the rule.
    4. Which Critical Tracking Events trigger new requirements for reference documents.
    5. Which Key Data Elements must be recorded and maintained for each Critical Tracking Event for each role. (These extend beyond “one forward and one back” traceability.)
    6. Special records requirements if you have a kill step.
    7. The proposed requirement that records be available to the FDA as soon as possible when requested, and not later than 24 hours, in an electronic, sortable spreadsheet.
    8. How the proposed rule can greatly reduce the costs you bear for recalls.
    9. How software solutions can make traceability and compliance much easier.

    Tamlin provides expert consulting to small and mid-sized food manufacturers on quality initiatives, governmental compliance, reduction of operational costs, and managing the plant floor. Our Food Manufacturing Conductor software exceeds the US Government traceability requirements, while producing tracking reports that used to take hours or days in just minutes and with great accuracy.

    If you have a traceability question or problem on your mind, don’t hesitate to reach out to us. We’re easy to talk to.