3-Hour Virtual Seminar on Food Facility Inspection

By attending this webinar you will learn Basics of Food Inspections and how they are conducted,The FDA Food Safety Modernization Act (FSMA), enables FDA to better protect public health by strengthening the food safety system.

Angela Bazigos
Angela Bazigos
Friday, September 27, 2019
09:00 AM PDT | 12:00 PM EDT
3 Hours

More Trainings by this Expert   Product Id : 502719

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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.

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:

  • Basics of Food Inspections and how they are conducted
  • The problem areas

Areas Covered in the Session:
  • 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
  • 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
  • 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

Learning Objectives:
  • Describe the different changes that can be made to an existing (marketed) device
  • Determine whether the intended change(s) to labeling, technology or materials, significantly affect the safety or effectiveness of an existing device, or its intended use
  • Substantiate and document decisions as to whether new 510(k) is or is not required
  • Apply FDA's risk-based assessment for modified devices to achieve least burdensome approach
  • Clarify how modifications to existing devices relate to the company's Quality System Regulation (QSR)
  • Locate the over 30 hypothetical examples that FDA uses to illustrate the process of determining when a 510(k) is required and how to document the decision

Who Will Benefit:
  • Anyone in a Food Manufacturer Including:
    • Operations
    • Safety Officers
    • Compliance and QA
    • Shop Floor
    • Washers
    • Microbiologists
    • Etc
  • FDA Food Inspectors

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,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 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 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.

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