Are You Ready for New FDA FSMA (Food Safety Modernization Act) Audit?
Duration : 60 Minutes
Gina M. Reo,
President, QAS, (Quality Assurance Strategies, LLC), private consultation for the Food and Beverage Industry specializing in Global Food Safety and Quality with expertise in Regulatory Compliance, Business Integration
FDA implemented the new Food Safety Modernization Act (FSMA), including the hazard analysis and risk-based preventive in 2016 to help industry manage potential hazards in producing safe food products. FSMA places primary responsibility on the owners and operators of food facilities to identify and control hazard risks, and intentionally grants facilities considerable flexibility in designing and implementing their food safety plans. In light of these new regulations, FDA introduced an enhanced audit approach to ensure food processors have adequately eliminated these potential risks in their food facilities. This course will examine new FDA authority, introduces examples of Preventative Controls, leading into minimal recommended preparation steps for handling the new FDA FSMA requirements, including managing Form #483 for non-compliances.
Why Should You Attend:
Processors or manufacturers registered with FDA and those that typically have an annual audit by federal investigators or state inspectors on behalf of FDA would benefit from these learning's and can utilize this information to better prepare for new FSMA targeted assessments.
Course Objectives:
• Expectations covered for new requirements for FSMA Audit by Regulators
• New Hazard Analysis Risk Preventative Controls (HARPC) or Food Safety Plan basics introduced
• Supply chain Preventative Controls outlined
• Legal Authority of FDA detailed, including watch-outs
• Importance of documentation requirements described
• Employee preparation and training essentials explained
• Closing a Successful Audit, including managing #483’s and confidentiality
Course Outline:
• New FSMA requirements overview
• Minimal requirement recommendations for FSMA
• Key Essentials to build your own playbook, the Food Safety Plan
• HARPC, what’s new from former HACCP approach
• Documentation needs that are vital
• New Legal Authority
• Preventative Controls
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
• Quality and Food Safety staff/mgt.,
• PCQI members,
• Operations leads/supervisors,
• Sanitation leads/supervisors,
• Plant management,
• Warehousing managers/leads,
• Maintenance and engineering leads/supervisors,
• Procurement team leads,
• Crisis coordinators and senior leadership in Food Industry wanting to understand the potential business impact on new FSMA requirements.
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
