FDA’s import and export programs are complex, detailed and undergo changes without notice to the public. The FDA’s and CBP’s new import and enforcement program operates with remarkably efficient software systems that can leave a firm scrambling for a resolution and end up suffering the expensive consequences of a detention. The information data base used by the FDA includes extensive information about foreign suppliers. If your foreign supplier does not meet the FDA’s requirements, your shipment will not be permitted entry, in some cases even before the products can be loaded onto the vessel or before it arrives at the port.

Foreign establishments are subject to the same manufacturing regulations as U.S. firms. There are inherent problems with foreign commerce, such as language and cultural differences. If a foreign firm’s manufacturing operation or its products fail any criteria, a detention, or even worse, a refusal becomes your next crisis. If your product is detained, you must now how to try and resolve the problem with the FDA. You have only ten days to figure out your plan and have FDA agree, which as not a given. On day 11, your product must either be destroyed or exported.

FDA offers special programs to automatically release entries provided pre-qualification criteria are met. This is especially valuable to importers of perishable goods. However, the FDA has begun to disqualify participants.

Import/export requirements can be confusing and costly if you do not understand the legal requirements. You need clarity, accurate knowledge, and solid business procedures to succeed.

Learning Objectives:

  • Understand how FDA and CBP legal and administrative requirements intersect
  • You can understand FDA’s legal requirements and somewhat esoteric policies
  • Understand FDA’s internal procedures for import operations
  • Learn how to mitigate and resolve import detentions
  • Learn how to avoid common problems
  • Develop practical ways to improve your import and export business
  • Learn how to interact with FDA and follow their procedures
  • Learn what happens to your if a foreign supplier is in trouble with FDA
  • Understand FDA’s import-for-export limitations
  • Understand the export requirements and prohibitions
Seminar Fee Includes:
Lunch
AM-PM Tea/Coffee
Seminar Material
USB with seminar presentation
Hard copy of presentation
Attendance Certificate
$100 Gift Cert for next seminar

Who will benefit:

  • Business Planning Executives
  • Regulatory Directors
  • In-house Legal Counsel and Contract Specialists
  • Venture Capitalists
  • Business acquisition Managers
  • Owners of New or Developing Import/Export Firms
  • International Trade and Logistics Managers
  • Import Brokers
  • Investors
  • Sales Managers

Topic Background:

Product subject to the FDA’s jurisdiction must meet the same legal requirements as domestic products. International public health issues impact whether a product can be imported and whether it can survive logistical nightmares. The FDA’s import program evolves to better manage new emerging problems and implement new procedures to make the process more efficient. The FDA and U.S. Customs and Border Protection (CBP) import procedures require the submission of precise computer entry data. The programs interact in real time. When and how you manage your data submission makes a significant difference in the successful execution of your import operations or your failures that suffer weight of lengthy delays that lower net profits. When the FDA detains your entry, you must know what to do. If not, FDA will refuse entry, which cannot be appealed, and your entry may ultimately seize and destroyed. Time is not on your side when you make mistakes.

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Day 01(9:00 AM - 4:30 PM)
  • 9:00 AM - 10:30 AM
    • FDA’s Legal Requirements and Violations
    • FDA and U.S. Custom Border Protection (CBP) Joint Import Operations
    • FDA Establishment Registration
  • 10:30 AM - 10:45 AM Break
  • 10:45 AM - 12:00 Noon
    • Information Required for Entry into U.S. Commerce
  • 12:00 Noon - 1:00 PM Lunch
  • 1:00 PM - 2:30 PM
    • Article Return for Repair
  • 2:30 PM - 2:45 PM Break
  • 2:45 PM - 4:30 PM
    • Entry Delays, Detentions, and Refusals
    • Notice of Action (NOA)
    • Detention Hearing Management
Day 02(9:00 AM - 4:30 PM)
  • 9:00 AM - 10:30 AM
    • Import Alerts
    • Foreign Inspections
  • 10:30 AM - 10:45 AM Break
  • 10:45 AM - 12:00 Noon
    • Voluntary Qualified Import Program for Food
    • Warning Letter Management
  • 12:00 Noon - 1:00 PM Lunch
  • 1:00 PM - 2:30 PM
    • FDA Export Requirements for Unapproved Products
    • FDA Export Certificates
  • 2:30 PM - 2:45 PM Break
  • 2:45 PM - 4:30 PM
    • FDA Import-for-Export Requirements
    • International Trade Shows
    • Personal Baggage
    • Compassionate Use
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Casper (Cap) Uldriks

Casper (Cap) Uldriks
Former Associate Center Director of FDA's CDRH

Casper (Cap) Uldriks, through his firm “Encore Insight LLC,” brings over 32 years of experience from the FDA. He conducted domestic and foreign inspections. He specialized in the FDA’s food and medical device programs as a field investigator, served as a senior manager in the Office of Compliance and as an Associate Center Director for Regulatory Guidance and Government Operations. He developed enforcement actions and participated in the implementation of new statutory requirements, such as FDA’s import/export program. He is recognized as an exceptional and energetic speaker. His comments are candid, straightforward and of practical value. He understands how FDA thinks and operates. Cap is the President of Encore Insight, LLC, a consulting service for FDA matters.

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