How to Survive an FDA Food Facility Inspection

Live Webinar

  • 180 minutes

About 48 million people (1 in 6 Americans) get sick, 128,000 are hospitalized, and 3,000 die each year from food borne 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 FDA Food Safety Modernization Act (FSMA), enables 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 will be necessary for FDA to provide oversight, ensure compliance with requirements and respond effectively when problems emerge.

Session Highlights:

Session 1: FDA Food Inspection Basics (Length: 60 minutes)

This session will walk you through this sometimes confusing process and apply it to Food Facility Inspections. It will begin with an overview of the FDA inspection program, followed by outlining inspection goals, inspection process and how the inspection is conducted. 

  • FDA Inspection Program Overview

  •  How FDA Conducts Inspections 

  • Types of FDA Inspections 

  • Possible FDA Inspection Outcomes and how to handle them

  •  Food Safety 

  •  Food Safety Basics 

  • Consumer Survey on Food Safety 

  •  Food Inspection Basics 

  •  Food Inspection Goals 

  • Communications with Food Facility before, during and after inspection 

Session 2: How to Prepare for a Successful Inspection (Length: 60 minutes)

 This session will explain the key factors for preparing for a successful inspection and will provide attendees with a checklist that FDA would use when inspecting your food facility. Attendees can also use this checklist to ensure inspection readiness in their plant. 

  • Key Factors for a Successful Inspection

  • How to prepare for a successful inspection

  •  Rodents 

  • Birds

  •  Insects 

  • Bacteria 

  • Parasites

  •  Molds 

  • Chemical Contaminants

  •  FDA-approved food inspection checklist and how to use it

Session 3: Foreign Food Facility Inspection Program (Length: 60 minutes)

FDA is increasing the number of routine inspections worldwide of foreign food facilities under the jurisdiction of the FDA that export to the United States (processors/manufacturers, packers/repackers, and holders of foods). This increase is mandated based on new requirements included in the FDA Food Safety Modernization Act (FSMA), as enacted by the U.S. Congress and signed into law by the President on January 4, 2011. FDA is also taking similar efforts with regard to domestic facilities to ensure that the U.S. food supply is safe.

Foreign food facility inspections are designed to:

  • Identify potential food safety problems before products arrive in the United States

  • Determine the compliance status of facilities to FDA’s requirements and food safety standards

  • Help the agency make admissibility decisions when food products are offered for importation into the United States

  • Help ensure that food products under FDA’s jurisdiction meet U.S. requirements under the Federal Food, Drug, and Cosmetic Act

This session will explain FDA’s program for foreign food facility inspections, from selection of facilities for inspection to how FDA works with local authorities to what to expect if an inspection has problems.

  • Foreign Food Facility Inspection Program

  • Selecting foreign food facilities for inspection

  • Notification of foreign Embassies and Competent Authorities

  • How to respond to any inspection citations and prevent future ones

  • Future Trends in Food Facility Inspections

  • Q&A

Why Should You Attend:

The Food and Drug Administration (FDA) considers establishment inspection one of its prime enforcement tools. Clearly, this is an important way of determining whether or not food firms are in compliance with the FDA's law and regulations. Many of the regulatory actions FDA takes against food firms are based on FDA's findings during inspections. During this webinars you will learn:

  •  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 

  • How to prepare for a successful inspection 

How to respond to any inspection citations and prevent future ones

Who Should Attend:

Anyone in a food manufacturer including:

  •  Operations

  •  Safety officers

  •  Compliance and QA 

  • Shop floor

  • Washers 

  • Microbiologists 

  • Etc 

  • FDA Food Inspectors

*You may ask your Question directly to our expert during the Q&A session.

 ** You can buy On-Demand and view it as per your convenience.

Angela Bazigos

Angela Bazigos

Angela Bazigos, is the CEO of Touchstone Technologies, Inc. She has 40 years of experience working in hospitals and Pharma industry. Her background includes companies like Roche, Novartis, Genentech and PricewaterhouseCoopers in GLP, GCP, GMP, Medical Device and Data Integrity Roles. She has held positions such as Chief Compliance Officer, QA Director and has acted on behalf CEO for communications with FDA. Ms. Bazigos is a Past President of PRCSQA, a member of the SQA CVIC, ASQ, DIA and RAPS. She works closely with the FDA on behalf of her clients. She consults to Life Science Investment Groups as well as to Pharma / Biotech / Medical Device companies on compliance matters, including strategy, submissions, quality assurance and remediation following action by the FDA. Has contributed to prototyping of 21 CFR 11 & CSV before promulgation to industry. Ms. Bazigos co-authored Computerized Systems in Clinical Research / Current Data Quality and Data Integrity Concepts with FDA, DIA and Academia. She holds a patent in speeding up software validation. She has been on the board for UC Berkeley’s Business School for Executive Education in Life Sciences and is now on the Stanford Who’s Who Registry for contributions to the Life Sciences industry.

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