Food Safety Modernization Act Webinar
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1 March 5, 2013 The Food Safety Modernization Act How will it impact your company?
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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
Transcript of Food Safety Modernization Act Webinar
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March 5, 2013
The Food Safety Modernization Act
How will it impact your company?
2
Panelists
George Salmas The Food Lawyers®
20+ years experience advising and protecting
food industry clients
Larry Johnson Stanton Associates LLC Management Consultants with a focus on the food &
beverage industry; Founder/President of a specialty foods
company
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
Lewis Stanton Stanton Associates LLC Management Consultants with a focus on the food &
beverage industry
Moderator
Legal Perspective IT Systems Perspective Business Owner Perspective
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
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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
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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
Put out for public comment
Regulations
Final Published Regulations with effective date
Regulations, when fully written and
implemented, will be over 3,000 pages
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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
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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
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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
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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
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HACCP Under FSMA
Hazard Analysis Critical Control Point
What is it?
What you need to know
IT implications – monitoring the control points
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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
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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
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FDA Recall Authority and Procedures
Recalls before FSMA
Recalls under FSMA
Making recalls easy using ERP and Quality Assurance
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Administrative Detention of Food
Basis for detention
Appeals to FDA
Federal Court Actions
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The bottom line on how the Food Safety Modernization Act affects you
Legal Perspective
IT Systems Perspective
George Salmas The Food Lawyers®
Lynda Roth LJR Consulting Services
Business Owner Perspective Larry Johnson
Stanton Associates LLC
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Offer to webinar participants*:
Each Alliance member would be pleased to offer a complimentary
one-hour consultation.
* Webinar participants within the food & beverage industry
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Contact Information
Lewis Stanton Stanton Associates LLC [email protected] 818-752-6500
Larry Johnson Stanton Associates LLC [email protected] 818-752-6500
George Salmas The Food Lawyers® [email protected] 310 556-0721
Lynda Roth LJR Consulting Services [email protected] 818-709-658
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Q & A
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Thank you for joining us!
