How to Successfully Manage an FDA High Risk Inspection 2015

Key Topics

• Regulatory requirements under FDA’s new preventative controls regulation – 21CFR Part 117
• What are high risk foods
• When a hazard analysis and HACCP plan or food safety plan are required
• Regulatory requirements under FDA’s regulations covering LACF (Part 113) and Seafood (Part 123)
• The importance of effective implementation of a HACCP plan or food safety plan
• The importance of a well written HACCP or food safety plan
• What FDA investigators look for during high-risk inspections – emphasis on LACF, seafood and dry RTE foods
• Problems that have caused HACCP plan implementation failures under seafood and juice HACCP
• The importance of well written SOPs that address effective controls over hazards that are reasonably likely to occur and cause food adulteration
• How to successfully deal with FDA investigators during an inspection and other FDA personnel by correspondence after an inspection
• New FDA records and biennial registration requirements under FSMA and reporting requirements under the Reportable Food Registry

Who should Attend

• Quality control managers and employees
• Plant managers
• Microbiologists
• Production managers and employees
• Importers/exporters
• Scientists
• Consultants
• Raw materials and ingredient manufacturers
• Sales
• Food science professors
• Human food warehouses
• Food Manufacturers
• Process authorities
• Food testing laboratories