Are You Ready for FDA FSMA Preventive Controls Audit?
  • CODE : GINA-0013
  • Duration : 60 Minutes
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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 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.

Highlights will include an intro to what to do on an audit, how to be ready, what is fair game for review, critical documents required, vital Food Safety Plan, focus on hazards or Hazard Analysis Risk Preventative Controls (HARPC), Supply chain Preventative Controls and importance of managing the audit, sampling, swabbing, warnings and wrap up meeting.

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
  • Supply chain Preventative Controls
Areas Covered
  • 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  
    o Closing a Successful Audit, including managing #483’s and confidentiality, Supply chain Preventative Controls

Course Level - Intermediate to advanced

Who Should Attend

  • Quality Control/Assurance and Food Safety professionals
  • Supervisors
  • Leads
  • Managers
  • Operations managers/supervisors
  • Sanitation managers
  • Supervisors or leads
  • Corporate quality managers
  • Operations personnel
  • Senior management
  • Plant management personnel
  • Third parties developing HACCP plans
  • Auditors and those with food safety inspection roles
  • Validation specialists
  • Consultants
  • Quality system auditors
  • PCQI’s

Why Should Attend

FDA implemented the new Food Safety Modernization Act (FSMA), including the hazard analysis and risk-based preventive in 2016 to help the 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.

  • $200.00



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