FDA FSMA Preventive Controls Inspection Hot Buttons for 2022
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, Prop 65, 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 the US and Canada compliance. Over 25+ years of food safety and quality experience, after holding successively senior positions with Colgate-Palmolive, Coca-Cola, Bestfoods NA, Unilever, 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. Along the way, implementation has taken a few twists and turns, including side-tracking with a pandemic.
So, what have we learned along the way and where is the FDA now focused with Food Safety improvements? 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. However, not all the industry has stepped up to mitigate risks effectively.
This course will examine new FDA direction and additional programs targeted to transform Food Safety for 2022 and beyond, including managing reviewing #483 violations for non-compliances.
- Expectations covered for new 2022 FSMA Audit by Regulators
- Hazard Analysis Risk Preventative Controls (HARPC) or Food Safety Plan basics covered from FDA identified gaps perspective
- New World Post FSMA, understanding new regulations
- COVID, a Bump in the Road or a New Normal
- Robust Food Safety Plan, Know Your Site and Programs, what you need for your own Food Safety Plan
- Required Documentation
- Sanitation Program to mitigate risks and watch-outs
- Environmental Monitoring Programs Essentials
- Other Needed Risk Mitigation Programs
- Employee Training Program Importance
- Corrective and Preventative Action (CAPA)
- Understanding Verification vs. Validation Programs
- Supplier Programs, recommended minimization requirements
- Next Steps
Course Level - Intermediate
Why Should Attend
Key FSMA takeaway points are covered, with requirements overview
explained with the minimal recommendations for successful FSMA
compliance. Key Essentials to examine your own playbook, the Food Safety
Plan (HARPC) are teased out in detail.
Documentation needs with an in-depth review of Preventative Controls the main focus of FSMA for food processors and mandatory Supply chain Preventative Controls are explained as well.