3.5 hr Virtual Boot Camp: How to Survive an FDA Food Facility Inspection

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.

This online training will begin with an overview of the FDA inspection program, followed by outlining inspection goals, inspection process and how the inspection is conducted. This session will further discuss 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.

The final session of this webinar 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.

Areas Covered in the Webinar:

Session 1: FDA Food Inspection Basics (Length: 90 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

Who Will Benefit:

Anyone in a food manufacturer including:

• QA Personnel
• Compliance Personnel
• Operations
• Safety officers
• Shop floor Personnel
• Washers
• Microbiologists
• FDA Food Inspectors

Angela Bazigos
CEO, Touchstone Technologies Inc

Angela Bazigos is the CEO of Touchstone Technologies Inc. She has 40 years of experience in the Life Sciences & Healthcare Industries. Experience combines Quality Assurance, Regulatory Compliance, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety and Turnarounds. Past employers / clients include Roche, Novartis, Genentech & PriceWaterhouseCoopers, Public Health Service. Positions include Chief Compliance Officer, http://morflearning.com/angelabazigos/, QA Director, Director of MIS. Co-authored & prototyped 21 CFR 11 guidance with FDA. Co-authored Computerized Systems in Clinical Research w/ FDA http://www1.diahome.org/~/media/4FA562336EBD46C58CDC43A8B7773095.ashx. Patent on speeding up software compliance https://www.google.com/patents/US8266578 . Recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom http://blogs.wsj.com/riskandcompliance/2015/07/24/using-training-to-bring-compliance-to-boardrooms/ . Comments / collaborates with FDA on new guidance documents. Former President of Pacific Regional Chapter of Society of Quality Assurance. Stanford’s Who’s Who for LifeSciences: http://www.stanfordwhoswho.com/Angela.Bazigos.7144112.html#overview.

Topic Background:

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 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.

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