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The FDA Final Food Defense Rules Under the Food Safety Modernization Act (FSMA) (TNS674Y)

Presented by: Dr. John M. Ryan
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Pre Recorded Webinar
60 minutes
  •  Tue, June 27, 2017

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Event Description
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Create a Food Defense Plan in Compliance with the FDA FSMA’s New Final Rules

The final rules entitled “Focused Mitigation Strategies to Protect Food Against Intentional Adulteration” under FDA FSMA, mean that companies must implement plans to prevent food under their control from intentional adulteration by performing vulnerability assessments, establishing mitigation strategies and procedures for monitoring, correcting and verifying a food defense plan. Implementation of food defense plans will most likely require capital asset planning.

These rules were finalized in September 2016 and companies have only between 3 and 5 years for full compliance. The newly finalized FDA FSMA rules will require that all registered food supply entities follow all applicable FSMA rules. All proposed rules are now law and provide the FDA with full enforcement powers. All companies are now open to new FDA and Department of Justice (DOJ) enforcement activities if there is evidence that the food operation does not comply with FSMA rules. The FDA fully intends to prosecute in the event of illness or death caused to humans.

The rules are applicable to all foreign and domestic companies required to be registered with the FDA except farms, very small businesses, animal foods, alcoholic beverages and operations where the container that directly contacts the food remains intact (unopened).

Under the final FSMA rules, a food company executive, manager or employee can now be charged with a crime even if they did not know they were selling a product that was contaminated or making people sick. The FDA and the DOJ are currently working together to diligently drive implementation of these new legal food safety requirements through the prosecution of company personnel who do not comply with preventive control rules. Their current prosecution efforts are focused on companies not in compliance if the company has caused a recall, illness or death whether or not the company has intentionally avoided compliance. In this session, Dr. John M. Ryan will discuss the FDA’s final food defense rules in detail and help you create an effective food defense plan to ensure compliance with the new rules under FSMA.

Session Highlights

  • The Final Rules on Focused Mitigation Strategies to Protect Food Against Intentional Adulteration
  • Exemptions and compliance dates
  • Assessing company needs (vulnerability)
  • Mitigation strategies
  • Plan basics
  • Preventive concepts
  • Verifying and validating food defense plan implementation
  • Test and correction

Session Benefits

  • Build your team
  • Review vulnerabilities
  • Incorporate the company defense plan into your overall food safety plan
  • Establish preventive controls
  • Verify implementation of defense strategies (assure your plan is in place)
  • Establish a preventive validation approach (prove your plan works)
  • Develop procedures
  • Document the process
  • Protect your company and personnel from lawsuits

Who should attend?

  • Upper and Mid-level personnel from all registered food operations
  • Food safety team members
  • Food quality personnel
  • Managers and supervisors in food operations
  • Sanitation specialists and teams
  • Food packing, processing, distribution and handling personnel
  • Food ingredient suppliers
  • Legal team members focused on food safety
  • Food safety leads and implementation team members
  • Maintenance operations personnel
  • Food facility personnel
  • Food importers whose food will be consumed in the U.S.
  • Food security personnel
  • Recall specialists
  • US Food Importers and Exporters to the US
  • Food Safety internal and external auditors and audit team members
  • Shipper Supervisor and Managers
  • Drivers
  • Distribution center operations personnel
  • Carrier and food transportation management
  • Food Buyers and Supply Chain Qualifiers
About Our Speaker(s)

Dr. John M. Ryan | Food Safety Process SpeakerDr. John M. Ryan
Dr. John M. Ryan is a certified Preventive Controls Qualified Individual (PQCI) specializing in food safety process control and food safety plan validation. He holds a Ph.D. in research and statistical methods and has extensive international manufacturing quality and operations experience in large and small manufacturi... More info

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    Event Title: The FDA Final Food Defense Rules Under the Food Safety Modernization Act (FSMA)
    Presenter(s): Dr. John M. Ryan

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