FDA Audit Preparation

Course date: to be defined

The course analyses the current USA FDA regulations, focusing on the inspections performed by competent authorities on the Italian food processors exporting to the USA.

Several topics will be dealt with during the two days: FDA regulations, how to get ready for an inspection, how the personnel directly involved in the audits should be prepared, how a Warning Letter or a FDA 483 (List of Observation) should be answered.

In an interactive and informal frame, the participants will be free to ask questions and put forwards specific cases of their interest.

AUDIENCE

Supervisors of thermal treatment systems, personnel directly involved in the production of low-acid and acidified foods, persons in charge with quality assurance and quality control, R&D personnel, auditors and inspectors, university and public administration staff performing food-related tasks.

TARGETS

• Provide companies exporting to the USA the instruments necessary to understand the current USA FDA regulations under the Food Safety Modernization Act;
• Provide practical guidance on what to expect and how to handle FDA food plant inspections;
• Tackle and debate with the teacher the topics covered during the course as well as the participant’s specific problems, in an informal and interactive environment.

CONTENTS

• FDA Regulations: Overview
  • Food, Drug and Cosmetic Act
  • Food Safety Modernization Act – Emphasis on imports
  • FDA’s changing culture under FSMA
• The FDA specific regulations and the inspections in food industry
  • CGMP (current good manufacturing practice)
  • LACF e AF (low-acid canned foods and acidified foods)
  • HACCP of seafoods and juices
  • Aseptic products
• FDA inspections in food industry
  • Requirements to be met in FDA inspections
  • Basic elements of the inspection
  • SOP (Standard operating procedure) for a FDA inspection – Behaviour of company’s staff
  • Behaviour of FDA inspector
  • Post-inspection interview
• Inspection to food manufacturers
  • Low Acid Canned Foods
  • Acidified Canned Foods
• Questions and answers

CERTIFICATION

Each participant will receive a training certificate at the end of the Seminar.