Preparing for FSMA Compliance: Are You Ready?

Overview

Detailed 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

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