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), the importance of the Preventative Control Quality Individual (PCQI), with documentation requirements. The 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.

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

Why should you attend?

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.

Who Will Benefit:-

Processors or manufacturers registered with FDA and those that typically have an annual audit by federal investigators or state inspectors on behalf of the FDA would benefit from these learnings 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