FDA Import and Export Requirements – Don’t get caught off-guard

The FDA’s import and export requirements have become more rigorous in the past few years. The litany of problems of contaminated food and drugs raised a red flag. A few years ago, contaminated cat food manufactured abroad became a driving example of the problem. Congress has since mandated that the FDA’s import program become more aggressive. The FDA’s strict requirements especially caught many foreign firms off-guard. The FDA has established offices in foreign countries to increase its oversight. The expectation is that foreign countries will cooperate in the FDA’s effort to raise the regulatory bar to protect the public health.

Firms that do not position their import and export business in conformance with the FDA and US Customs Border Patrol requirements can face onerous costs. With what you learn from the webinar and apply, you can avoid typical problems and learn how to deal with tough problems when they occur.

This webinar covers critical issues that any FDA regulated firm should understand to survive regulatory scrutiny. Awareness of the topics, at a minimum, will help you ensure your compliance profile import/export practices and, where appropriate, the need to improve it. Critical issues will be discussed so you can develop and maintain an effective and efficient import / export business. The topics cover legal requirements and practical business operations. Given the FDA’s increased scrutiny of international trade, understanding the following topics is essential.

Areas Covered in the Session :
Information required by law
Risk mitigation strategy
Detention resolution
Negotiating with FDA
Warning Letters
“Import for Export” requirements
Export requirements and export certificates

Who Will Benefit:
Corporate Import/Export Department
Regulatory Affairs – Senior Managers
Financial Planning Department
International Shipping Managers
Import Brokers
Foreign Manufacturers

Casper E. Uldriks

Casper (Cap) Uldriks brings over 32 years of experience from the FDA. He specialized in the FDA’s medical device program as a field investigator, served as a senior manager in the Office of Compliance and as an Associate Center Director for the Center for Devices and Radiological Health. He developed enforcement actions and participated in the implementation of new statutory requirements. He is recognized as an exceptional and energetic speaker. His comments are candid, straightforward and of practical value. He understands how FDA thinks, operates and where it is headed. Cap is the President of Encore Insight LLC, a consulting and training service for FDA law and operations.

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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance