Tougher Import Rules for FDA Imports in 2018

Course

In Opfikon (Switzerland)

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Price on request

Description

  • Type

    Seminar

  • Level

    Advanced

  • Location

    Opfikon (Switzerland)

  • Class hours

    9h

  • Duration

    2 Days

Third party establishment inspection entities

FDA and the Customs and Border Patrol Service (CBP) have become increasingly sophisticated and equally demanding in the submission of import information and adherence to government procedures. Firms that fail to understand and properly execute an import and export program find their shipments delayed, detained or refused. As of December 2016, FDA and CBP officially implemented the Automated Commercial Environment (ACE) entry filing system. You either meet ACE requirements or face entry refusals and monetary penalties of up to $10,000 per offense. Other factors can derail the expectation of a seamless import entry process. The course covers detailed information about the roles and responsibilities of the various parties involved with an import operation and how to correct the weakest link(s) in the commercial chain. The course will include tips on how to understand FDA's thinking, negotiate with the FDA and offer anecdotal examples of FDA's import program curiosities.

Price: $1,295.00
(Seminar Fee for One Delegate)
Register for 5 attendees Price: $3,885.00
$6,475.00 You Save: $2,590.00 (40%)*
Register now and save $200. (Early Bird)

Facilities

Location

Start date

Opfikon (Switzerland)
See map
Hohenbuhlstrasse 10, 8152

Start date

On request

About this course

Domestic importers
Foreign exporter
Initial importers
International trade executives
Venture Capitalists
Marine insurance underwriters
Import Brokers
Regulatory affairs managers
Import / Export consultants
In-house counsel
Contract specialists
Logistics managers
Third party establishment inspection entities
Sales managers
Investors

What happens when your product is detained? FDA will begin a legal process that can become an expensive business debacle. You must respond fully within short timeframes. This is not the time for you to be on a learning curve. You need to have a plan in place and know what you are doing.

The FDA is steadily increasing the legal and prior notice information requirements. If you do not know what those requirements are and you initiate a shipment, your product is figuratively dead in the water. You must be accurate with the import coding information and understand the automated and human review process. If not, you can expect detained shipments. CBP is implemented a new "Automated Commercial Environment" computer program that changes import logistics and information reporting for FDA regulated products. Your shipment may be stopped before it is even loaded at the foreign port.

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Reviews

Subjects

  • Customs
  • Export
  • Import
  • Domestic cleaning
  • Initial Teacher
  • Regulatory Compliance
  • Regulatory affairs managers
  • Capitalists
  • Domestic
  • Fda

Teachers and trainers (1)

Casper  Uldriks

Casper Uldriks

ex-FDA Expert and former Associate Center Director of CDRH

Casper (Cap) Uldriks owns Encore Insight LLC, which provides consulting services on FDA Law. He 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 underst

Course programme

Day 1 Schedule Lecture 1:

FDA Legal Authority Customs and Border Control (CBP) Import Process FDA Import Process Registration and documentation

Lecture 2:

FDA Import Process (continued)

  • Import Brokers
  • Prior Notice Information
  • CBP and FDA computer programs
  • Import Codes
  • Bonds and Bonded Warehouses
  • FDA "Notice of Action"
Lecture 3:

Import Delays Import Alerts Detention Refusals

Day 2 Schedule Lecture 1:

Foreign Inspections FDA 483 - Inspectional Observations

Lecture 2:

FDA Warning Letters and Automatic detention

Lecture 3:

FDA Import Hypothetical

Lecture 4:

FDA Export Program Special Import Issues

  • Trade Shows
  • Personal Use
  • Compassionate Use

Tougher Import Rules for FDA Imports in 2018

Price on request