Are You Ready for FDA FSMA Preventive Controls Audit?

Gina Reo, is a Keynote Speaker at Compliance Key. She is the President, QAS, (Quality Assurance Strategies, LLC), private consultation for the Food and Beverage Industry specializing in Global Food Safety and Quality with expertise in Regulatory Compliance, Prop 65, Crisis Management, Business Integration, and Due Diligence M & A Compliance Risk Assessments.  Formerly, Vice President, Food Safety, Weston Foods (WF), a GWL Canadian company and North American leader in bakery products. Transformed organization toward World Class Excellence for Food Safety by framing Food Safety Roadmap Strategy ........


Detail overview of FDA FSMA rule, leading into recommended preparation steps for handling the new FDA FSMA audit when investigators come to your door. Drilling down, will focus on Food Safety Plan hazards or Hazard Analysis Risk Preventative Controls (HARPC), importance of the Preventative Control Quality Individual (PCQI), with documentation requirements. Webinar will also cover how to handle a "Swabathon", where FDA's new RTE (Ready To Eat) Listeria Monocytogenes Guidance may come into play, and expectations for FDA FSMA audits.

Why should you attend this webinar?

FDA expectations on the new Preventative Controls audits are daunting, if one is not prepared it could result in non-compliances or #483, or worse for an organization. This webinar will detail the watch-outs and best approaches to manage FSMA.

Areas Covered in the Session:

  • New World Post FSMA, what to expect
  • What to do when FDA shows up at the door 
  • Audit Readiness, what/who you need to have on hand
  • FDA FSMA Inspection authority
  • How to be Inspection and Swab Ready at All Times
  • Robust Food Safety Plan, Know Your Site and Programs
  • Critical Detailed Documentation
  • Sanitation Program must mitigate risks
  • Critical Environmental Monitoring Programs 
  • Other Risk Mitigation Programs (High Risk Ingredients, Foreign Material Removal Systems, Supplier Programs, Allergen Program, Zoning and Traffic Control, Proof of Mock Recall, etc.)
  • Employee Sanitation, Environmental Monitoring and Training Programs 
  • Importance
  • Corrective and Preventative Action (CAPA) must be effective
  • FDA Wrap Up and Actions, including managing potential #483 Observations FSMA Overview and Audit stats
  • FDA Wrap Up Meeting Expectations/Closing Audit
  • How to handle a #483 Warning
  • Takeaways

Who can Benefit:

Processors or manufacturers registered with FDA and those that typically have annual audit by federal investigators or state inspectors on behalf of FDA would benefit from these learning's and can utilize this information to better prepare for new FSMA targeted assessments?

  • All Food processors
  • packagers and handlers under FDA registration
  • Quality and Food Safety staff/mgt.
  • PCQI members
  • Operations leads/supervisors
  • Sanitation leads/supervisors
  • plant management, warehousing managers/leads
  • maintenance and engineering leads/supervisors
  • procurement team leads
  • crisis coordinators
  • company leadership
  • risk managers

Webinar Id: LSHCGR0010

Training Options:

Duration: 60 mins

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 Recorded: [Six month unlimited access]

 $231 (Single Attendee)  $699 (Unlimited Attendee)

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