Are You Ready for FDA FSMA Preventive Controls Audit Post COVID?

Gina  Reo
Instructor: Gina  Reo
Date: Tuesday May 17, 2022

11:00 AM PDT | 02:00 PM EDT

Duration: 60 Minutes
Webinar Id: 20599

Price Details

Live Webinar
$150. One Attendee
$290. Unlimited Attendees
Recorded Webinar
$190. One Attendee
$390. Unlimited Attendees
Combo Offers   (Live + Recorded)
$289 $340   One Attendee
$599 $680   Unlimited Attendees

Unlimited Attendees: Any number of participants

Recorded Version: Unlimited viewing for 6 months (Access information will be emailed 24 hours after the completion of live webinar)


Food Manufacturing, processing, and distribution are considered a critical operation in a crisis, however current global pandemic has made it near impossible for food safety professionals and auditors to perform their normal routine inspections and checks. Many certification programs have granted extensions; however, these lapses have put more pressure on manufacturers to ramp back up quickly for FSMA PC audits by FDA inspectors, many of which are not prepared since COVID. We will cover all the minimum requirements along with best practices to successfully navigate this audit, avoiding a #483.

Why you should Attend:

FDA implemented the Food Safety Modernization Act (FSMA), including the hazard analysis and risk-based preventive in 2016 to help the industry manage potential hazards in producing safe food products. Since then, in midst of the rollout COVID Pandemic struck and placed audits in limbo. We will examine FSMA requirements, learnings coping with COVID, and go-forward plans, especially with the new administration.

FSMA places primary responsibility on the owners and operators of food facilities to identify and control hazard risks and intentionally grants facilities considerable flexibility in designing and implementing their food safety plans. In light of these new regulations, FDA introduced an enhanced audit approach to ensure food processors have adequately eliminated these potential risks in their food facilities. This course will examine new FDA authority, and introduces examples of Preventative Controls, leading to minimal recommended preparation steps for handling the new FDA FSMA requirements, including managing Form #483 for non-compliances.

Areas Covered in the Session:

  • Expectations covered for new requirements for FSMA Audit by Regulators
  • COVID landscape
  • New Hazard Analysis Risk Preventative Controls (HARPC) or Food Safety Plan basics introduced
  • Supply chain Preventative Controls outlined
  • Legal Authority of FDA detailed, including watch-outs
  • The importance of documentation requirements described
  • Employee preparation and training essentials explained
  • Closing a Successful Audit, including managing #483's and confidentiality

Who Will Benefit:

  • Quality and Food Safety Staff/Management
  • 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
  • Senior Leaders

Speaker Profile
Gina Reo 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 for fast-tracking compliance to FSMA (Food Safety Modernization Act), SFCA (Safe Foods for Canadian Act) and new NLEA (Nutrition Labeling Education Act) for US and Canada compliance.

Over 25+ years of food safety and quality experience, after holding successive senior positions with Colgate-Palmolive, Coca-Cola, Bestfoods NA, Unilever, YUM! Brands and Quiznos (Board). Prior to joining Weston Foods, held position of Quality Director with Mondelez International (formerly Kraft Foods) in Europe, (Zurich, Switzerland) and Cadbury as QA Chocolate Director (Quality, Environmental, and Health & Safety) for NA/Europe/Global.

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