FDA’s Mandatory Import Requirements
Duration : 60 Minutes
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 specialized in the FDA’s medical device program as a field investigator, served as a senior manager in the Office of Compliance and an Associate Center Director for the Center for Devices and Radi Read more
The FDA’s import program is complex, detailed and undergoes changes without much notice to the public. The import database used by the FDA includes extensive data about foreign manufacturers, individual establishments and the products they typically sell in the U.S. This means foreign manufacturers and exporters must complete specific steps before they can start sending products to U.S. If the steps are not followed and the required information submitted, your business with the U.S. stops right there. FDA can slow the importing process by issuing notice of action (NOA) which says whether your product is released or being detained. You need to understand what your “detention” means and what you should do. You must either correct the problem, destroy the product or send it outside of U.S. jurisdiction. Otherwise, the fines add up fast.
Background:
The FDA continues to update its import program to better manage new problems and to use new procedures that make the process more efficient. The FDA and U.S. Customs and Border Protection (CBP) now require the use of computer programs to submit entry data that requires precise coding. The program acts in real time for the exchange of incoming and outgoing data with you and your import broker. When and how you manage the computer programs make a significant difference in the success of your import operations and net profits. When you get into trouble, you must know what to do and resolve problems quickly.
Course Objectives:
• Understand how FDA and CBP legal and administrative requirements intersect
• Identify your required data elements prior to import operations
• Foreign establishment registration
• Notice of Actions (NOA)
• Detention/Refusal/Import Alerts
Course Outline:
• Foreign Establishment Registration Requirements
• Automated Commercial Environment (ACE) computer system
• Affirmation of Compliance
• Sensitive codes
• Notice of Action
• Refusals and Import Alerts
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
• Regulatory Import Directors
• In-house Legal Counsel and Contract Specialists
• Venture Capitalists
• Business Acquisition Managers
• Owners of New or Developing Import Firms
• International Trade and Logistics Managers
• Investors
• Sales Managers
• Business Planning Executives
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
100% MONEY BACK GUARANTEED
Refund / Cancellation policyGet In Touch
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