Are You Ready for New FDA FSMA (Food Safety Modernization Act) Audit?
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, and Due Diligence. Formerly, Vice President, Food Safety (Officer), Weston Foods (WF), a GWL Canadian company and North American leader in bakery products. Transformed organization toward World Class Excellence for Food Safety within four years by framing Food Safety Roadmap Strategy. This included fast-tracking to FSMA (Food Safety Modernization Act), SFCA (Safe Foods for Canadian Act) and new NLEA (Nutrition Labeling Education Act) for US and Canada compliance.
Over 25+ years of food safety and quality experience, after holding successive senior positions with Colgate-Palmolive, Coca-Cola, Unilever, Bestfoods NA, YUM! Brands and Quiznos (Board). Prior to joining Weston Foods, held the position of Quality Director with Mondelez International (formerly Kraft Foods) in Europe, (Zurich, Switzerland) and Cadbury as QA Chocolate Director (Quality, Environmental, and Health & Safety) for NA/Europe/Global.
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.
Key FSMA Audit takeaway points would include
- 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
- 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
Who Should Attend
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.
Why Should 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.