FDA Import and Export Requirements

Duration: 60 Minutes
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.
FDA Import Export Requirement
Instructor: Casper E Uldriks
Product ID: 500097
  • Information required by law
  • Risk mitigation strategy
  • Detention resolution
  • Negotiating with FDA
  • Warning Letters
  • "Import for Export" requirements
  • Export requirements and export certificates
The FDA's import 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.

Why Should you Attend:
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.

Objectives of the Presentation:
The 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.

Who can Benefit:
  • Corporate import/export managers
  • Regulatory Affairs - senior managers
  • Financial planning managers
  • International shipping managers
  • Import brokers
  • Foreign manufacturers
Live Session - How it works
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  • Access to the recording is valid only till 6 months starting from the date of purchase.
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$300
Recorded Session for one participant
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Live Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Mr. Uldriks held a number of positions at FDA, such as an investigator in FDA's New England office, in the Office of the Commissioner in Legislative Affairs and in the Center for Devices and Radiological Health (CDRH), where he served as CDRH's Associate Director for Regulatory Guidance and Government Affairs. He helped to guide CDRH to develop and implement various medical device related amendments to the Food, Drug, and Cosmetic Act, regulations and guidance documents. For years he has trained FDA staff on medical law and has been a featured speaker at many professional conferences involving FDA's medical device program.
Bar Admissions: Massachusetts, 1986 and District of Columbia, 2011
Education: Suffolk University Law School, Boston, Massachusetts, 1986.
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