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
In-Person Seminar going Virtual with increased learner satisfaction.
Yes, attend this seminar from anywhere. We are making it real and more interactive – Here's a sneak peek:Our enhanced delivery process and technology provides you an immersive experience and will allow you to access:
- The real-time and live presentation as in in-person events
- Private chat for company-specific conversation – the same as you would get in an in-person seminar
- Opportunities to connect with your peers to share knowledge at a different time and have group discussions
- Live workshop activities
- Live Q&A during the event and offline Q&A assistance after the event
- As usual more content, activities and case studies and now adding homework for a comprehensive understanding
- Certification
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.
- 8:00 AM - 9:30 AM
- Statutory Provisions for Imports and Exports
- Joint Import Operations: FDA / Customs Border Patrol and Protection (CBP)
- FDA Required Information
- 9:30 AM - 9:45 AM Break
- 9:45 AM - 11:30 AM
- FDA Required Information (continued)
- FDA and CBP Computer Programs
- 11:30 AM - 12:15 PM Lunch
- 12:15 PM - 1:30 PM
- FDA and CBP Joint Operations
- American Goods Returned
- 1:30 PM - 1:45 PM Break
- 1:45 PM - 3:00 PM
- Return for Repair
- Electronic Emission Product – Accession Number
- 8:00 AM - 9:30 AM
- Import Delays and Detention
- Detention Hearing
- Product Reconditioning Proposal
- Voluntary Qualified Importer Program
- 9:30 AM - 9:45 AM Break
- 9:45 AM - 11:30 AM
- Foreign Inspections
- Respond to Inspection Form FDA-483 / Warning Letter
- Face-to-Face Meeting with the FDA
- 11:30 AM - 12:15 PM Lunch
- 12:15 PM - 1:30 PM
- FDA Export Program
- FDA Export Reform and Enhancement Act 1996
- 1:30 PM - 1:45 PM Break
- 1:45 PM - 3:00 PM
- Import-for-Export
- International Trade Shows
- Compassionate Use
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.
