How to Survive an FDA Food Faculty Inspection – Virtual Bootcamp
How to Survive an FDA Food Facility Inspection Virtual Boot Camp
Presented By: Angela Bazigos
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According to the FDA, establishment inspections are one of the primary enforcement tools to ensure that food firms are in compliance with FDA regulations. Many regulatory actions of the FDA against food firms are based on the agency’s findings during inspections.
Overview:
About 48 million people (1 in 6 Americans) get sick, 128,000 are hospitalized, and 3,000 die each year from foodborne diseases, according to recent data from the Centers for Disease Control and Prevention. This is a significant public health burden that is largely preventable.

The Food Safety Modernization Act (FSMA) enables the FDA to better protect public health by strengthening the food safety system. It recognizes that preventive control standards improve food safety only to the extent that producers and processors comply with them. Therefore, it is necessary for the FDA to provide oversight, ensure compliance with requirements and respond effectively when problems emerge, according to the agency. The FDA conducts food safety inspections for a variety of reasons, such as during routinely scheduled investigations and surveys, or to respond to a reported problem.

This Virtual Boot Camp with food safety expert Angela Bazigos will provide an overview of the FDA inspection program, how to prepare for an inspection of your facility and the FDA program that applies to foreign food facility inspections.
Session Benefits
This Virtual Boot Camp will help you learn about:
  • Food safety basics
  • Basics of food inspections and how they are conducted
  • The problem areas
  • Food inspection checklist used by the FDA to prepare for inspection
  • Foreign food facility inspection program
  • Preparing for a successful inspection
  • Responding to any inspection citations and preventing future ones
Session Details
Session 1: FDA Food Inspection Basics

Length: 60 minutes

It is in your best interest to fully understand the FDA’s inspection procedures. This session will walk you through the sometimes confusing FDA inspection process and will apply it to food facility inspections. It will begin with an overview of the FDA inspection program, followed by outlining inspection goals, the inspection process and how the inspection is conducted.
Session 2: How to Prepare for a Successful Inspection

Length: 60 minutes

This session will explain the key factors that help in preparing for a successful inspection and will provide you with a checklist that the FDA would use when inspecting your food facility. You can also use this checklist to ensure inspection readiness in your plant.
Session 3: Foreign Food Facility Inspection Program

Length: 60 minutes

According to HHS, the FDA has increased the number of worldwide routine inspections of foreign food facilities that are under the FDA’s jurisdiction and that export to the United States. This session will explain the FDA’s program for foreign food facility inspections – from selection of facilities for inspection, to how the FDA works with local authorities, to what to expect if an inspection reveals problems.
Who Will Benefit
Anyone in a food manufacturer including:
  • Operations
  • Safety officers
  • Compliance and QA personnel
  • Shop floor personnel
  • Washers
  • Microbiologists
  • FDA food inspectors
About Our Speaker
Dr. John RyanAngela Bazigos is the CEO of Touchstone Technologies, Inc. She has 40 years of experience working in hospitals and the pharmaceutical industry. Her background includes positions at companies such as Roche, Novartis, Genentech and PriceWaterhouseCoopers in GLP, GCP, GMP, medical device and data integrity roles. She has held the positions of chief compliance officer and QA director and has acted on behalf of CEOs for communications with the FDA.

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