The Food Safety Modernization Act

Transcription

1 The Food Safety Modernization Act How will it impact your company? March 5,

2 Panelists Legal Perspective IT Systems Perspective Business Owner Perspective George Salmas The Food Lawyers 20+ years experience advising and protecting food industry clients Lynda Roth LJR Consulting Services Business and IT Consultant; specializes in using technology to increase profitability and productivity in regulated industry such as food and pharmaceuticals Larry Johnson Stanton Associates LLC Management Consultants with a focus on the food & beverage industry; Founder/ President of a specialty foods company Moderator Lewis Stanton Stanton Associates LLC Management Consultants with a focus on the food & beverage industry 2

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 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 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 LAW Regulations, when fully written and implemented, will be over 3,000 pages Regulations Put out for public comment Final Published Regulations with effective date 5

6 Structure of the FSMA Title I Improving Capacity to Prevent Food Safety Problems Title II Improving Capacity to Detect and Respond to Food Safety Problems Title III Improving The Safety of Imported Food Title IV Miscellaneous Provisions = OUR FOCUS TODAY 6

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 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 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 HACCP Under FSMA Hazard Analysis Critical Control Point What is it? What you need to know IT implications monitoring the control points 10

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 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 FDA Recall Authority and Procedures Recalls before FSMA Recalls under FSMA Making recalls easy using ERP and Quality Assurance 13

14 Administrative Detention of Food Basis for detention Appeals to FDA Federal Court Actions 14

15 The bottom line on how the Food Safety Modernization Act affects you Larry Johnson Stanton Associates LLC Lynda Roth LJR Consulting Services George Salmas The Food Lawyers Business Owner Perspective IT Systems Perspective Legal Perspective 15

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 Contact Information Lewis Stanton Stanton Associates LLC George Salmas The Food Lawyers Larry Johnson Stanton Associates LLC Lynda Roth LJR Consulting Services

18 Q & A 18

19 Thank you for joining us! 19