Food Safety Modernization Act Webinar


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A webinar presented by the Food & Beverage Industry Alliance, covering the legal, IT and business perspectives of the FDA's Food Safety Modernization Act

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Food Safety Modernization Act Webinar

  1. 1. The Food Safety Modernization ActHow will it impact your company? March 5, 2013 1
  2. 2. Panelists Legal Perspective IT Systems Perspective Business Owner Perspective George Salmas Lynda Roth Larry Johnson The Food Lawyers® LJR Consulting Services Stanton Associates LLC 20+ years experience Business and IT Consultant; Management Consultants advising and protecting specializes in using technology to with a focus on the food & food industry clients increase profitability and beverage industry; Founder/ productivity in regulated industry President of a specialty foods such as food and pharmaceuticals company Moderator Lewis Stanton Stanton Associates LLC Management Consultants with a focus on the food & beverage industry 2
  3. 3. Overview of Topics   FSMA law - overview & structure   Inspection of records   Food facilities registration and suspension   HACCP   FDA inspection   Tracking food shipments   FDA recalls and administrative detention 3
  4. 4. Goals of Our Program   Giving the C-level exec an overview of the law to better lead the company   Provide an understanding of how technology can help aid the process 4
  5. 5. FSMA law is not yet complete   Regulations not yet implemented   Relationship of FSMA statute and Food & Drug Administration regulation   Additional programs as regulations go into effect Regulations, when fully written and LAW implemented, will be over 3,000 pages Put out for Regulations public comment Final Published Regulations with effective date 5
  6. 6. Structure of the FSMA Title I Title II Improving Capacity to Improving Capacity to Prevent Food Safety Detect and Respond to Problems Food Safety Problems Title III Title IV Improving The Safety Miscellaneous of Imported Food Provisions = OUR FOCUS TODAY 6
  7. 7. Inspection of Records and Protecting Trade Secrets  When the FDA has the right to copy your records  What can and cannot be copied  Protecting trade secrets contained in copied documents   FDA and the Freedom of Information Act 7
  8. 8. Inspection of Records - IT implications  Options for setting up your records   Set up directories on different servers   Get a good document management system   Get a good ERP system 8
  9. 9. Food Facilities Registration and Suspension   Who must register   FDA facilities registration number   Suspension of registration   Effect of suspension of registration   Hearing on suspension within 2 business days of suspension   Reinstatement of registration 9
  10. 10. HACCP Under FSMA   Hazard Analysis Critical Control Point   What is it?   What you need to know   IT implications – monitoring the control points 10
  11. 11. FDA Inspection of Domestic Food Facilities   “High Risk” and “Low Risk” food facilities   How a strong ‘Quality Compliance’ system can aid in being a low risk food facility   Frequency of inspections   FDA inspection fees   Technology and the FDA inspection process   Systems that demonstrate a high level of organization 11
  12. 12. Tracing and Tracking Food Shipments   Records that must be kept   “One step up and one step down” the food chain   Tracking batches, lots and cases   The role of CRM, ERP and Quality Compliance systems in record keeping   How the right ERP system can make tracking automatic 12
  13. 13. FDA Recall Authority and Procedures   Recalls before FSMA   Recalls under FSMA   Making recalls easy using ERP and Quality Assurance 13
  14. 14. Administrative Detention of Food   Basis for detention   Appeals to FDA   Federal Court Actions 14
  15. 15. The bottom line on how theFood Safety Modernization Actaffects you Business Owner Perspective Larry Johnson Stanton Associates LLC IT Systems Perspective Lynda Roth LJR Consulting Services Legal Perspective George Salmas The Food Lawyers® 15
  16. 16. Offer to webinar participants*: Each Alliance member would be pleased to offer a complimentary one-hour consultation.* Webinar participants within the food & beverage industry 16
  17. 17. Contact InformationLewis Stanton George SalmasStanton Associates LLC The Food Lawyers® George.Salmas@thefoodlawyers.com818-752-6500 310 556-0721Larry Johnson Lynda RothStanton Associates LLC LJR Consulting lynda.roth@ljrconsultingservices.com818-752-6500 818-709-658 17
  18. 18. Q&A 18
  19. 19. Thank youfor joining us! 19