Prepare for an FDA Food Facility Inspection:Virtual Boot Camp

Product Id : FDA121
Instructor : Angela Bazigos
Jul 31, 2018 11:00 AM ET | 10:00 AM CT | 08:00 AM PT | 180 Minutes (Boot Camp)

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Description

Prepare Your Food Facility for a Successful FDA Inspection - How to Comply with the Agency’s Laws and Regulations.

Every year, millions of Americans get sick—and some even die—because of foodborne diseases, according to the Centers for Disease Control and Prevention. And thanks to the Food Safety Modernization Act, the Food and Drug Administration (FDA) is out to curb that largely preventable problem. For food producers, that means you’d better expect—and prepare for—scrutinizing inspections.

Join regulatory compliance expert Angela Bazigos as she tackles food safety and the FDA’s inspection process in detail in this live audio boot camp. Bazigos will walk you through the FDA’s oversight program and teach you how to comply with the agency’s laws and regulations. She’ll also instruct you on what to do when problems emerge. Plus, you’ll get an insider’s take on how to ace an FDA inspection by following the very checklist the agency uses to spot your deficiencies.

Why Should You Attend:

After attending this comprehensive audio event, you will understand: food safety basics, the inspection process, common problems areas, and special considerations for foreign facilities. You’ll come away equipped, not only to prepare for an inspection, but also to handle any citations issued—and to prevent future tickets from being written. If you are in the food industry, attending this soup-to-nuts regulatory compliance boot camp should be a requirement

During this webinar 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

Session 1: FDA Food Inspection Basics 

Length: 60 minutes | Time: 01:00 PM EST to 02:00 PM EST

FDA may conduct an inspection of your operation for a variety of reasons, such as a routinely scheduled investigation, a survey, or a response to a reported problem. The investigator will present credentials and Notice of Inspection (FDA Form 482) upon arriving at your plant. A knowledgeable person in your firm, such as the plant or production manager, preferably designated ahead of time, should accompany the investigator at all times. It is in your best interest to fully understand FDA inspection procedures. When you are unsure of certain actions taken by the investigator, don’t hesitate to ask questions. Usually, the investigator will examine your production process, look at certain records and collect samples.

At the conclusion of the inspection, the investigator will discuss with your firm management any significant findings and concerns; and leave with your management a written report of any conditions or practices, which, in the investigator’s judgment, indicate objectionable conditions, or practices. This list of Inspectional Observations also called an FDA Form-483, can be used by your firm management as a guide for corrective action, since the FDA representative will not usually recommend specific corrective measures. Your firm can and should respond to the FDA-483 during the discussion with the investigator. In fact, corrective actions or procedural.

  • 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
  • How the inspection is conducted

Break Time: 02:00 PM EST - 02:10 AM EST | Duration: 10 minutes

Session 2: How to Prepare for a Successful Inspection

Length: 60 minutes | Time: 02:10 PM EST to 03:10 PM EST

Session Highlights:

  • How to prepare for a successful inspection: rodents, birds, insects, bacteria, parasites, molds, and chemical contaminants
  • The FDA-approved food inspection checklist and how to use it.

Break Time: 03:10 PM EST - 03:20 PM | Duration: 10 minutes

Session 3: Foreign Food Facility Inspection Program

Length: 60 minutes | Time: 03:20 PM to 04:20 PM EST

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

Who Will Benefit:

Anyone in a food manufacturer including:

  • Operations Managers
  • Safety officers
  • Compliance and QA
  • Shop floor
  • Microbiologists
  • FDA Food Inspectors
  • Quality Professionals
  • Director
Speaker Profile:

Angela Bazigos is the CEO of Touchstone Technologies Inc. She has degrees in Microbiology and Computing and 40 years of experience in the Life Sciences, Healthcare & Public Health Services. Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety & Turnarounds. Past employers / clients include Royal Berkshire Hospital, Roche, Novartis, Genentech, PriceWaterhouseCoopers & Stanford Hospital. Positions include Chief Compliance Officer : http://morflearning.com/angelabazigos/, Director of QA and MIS Director.  Co-authored & prototyped 21 CFR 11 guidance with FDA.  Co-authored Computerized Systems in Clinical Research w/ FDA & DIA:

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/

Includes training for Society of Quality Assurance. 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  


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