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

1. The Food Safety
Modernization Act
How will it impact your company?
March 5, 2013
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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
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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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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
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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
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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
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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
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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
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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
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10. 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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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
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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
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13. FDA Recall Authority and Procedures
 Recalls before FSMA
 Recalls under FSMA
 Making recalls easy using
ERP and Quality Assurance
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14. Administrative Detention of Food
 Basis for detention
 Appeals to FDA
 Federal Court Actions
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15. The bottom line on how the
Food Safety Modernization Act
affects you
Business Owner Perspective
Larry Johnson
Stanton Associates LLC
IT Systems Perspective
Lynda Roth
LJR Consulting Services
Legal Perspective
George Salmas
The Food Lawyers®
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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
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17. Contact Information
Lewis Stanton George Salmas
Stanton Associates LLC The Food Lawyers®
lstanton@stantonassoc.com George.Salmas@thefoodlawyers.com
818-752-6500 310 556-0721
Larry Johnson Lynda Roth
Stanton Associates LLC LJR Consulting Services
ljohnson@stantonassociates.com lynda.roth@ljrconsultingservices.com
818-752-6500 818-709-658
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18. Q&A
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19. Thank you
for joining us!
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