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Seminar Summary:

The FDA continues to change its import program to better manage new problems and to use new procedures to make the whole process easier. (see full course description)

 
 
 

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Training Course Syllabus:


FDA’s New Import Program Concerning International Consequences - FDA Compliance Training Seminar

2-day In-person Seminar By: Casper E. Uldriks, Former Associate Center Director of FDA's CDRH

Course Description:

The FDA continues to change its import program to better manage new problems and to use new procedures to make the whole process easier. The FDA and U.S. Customs and Border Protection (CBP) are relying more and more on computer programs to expedite the import process. When and how you use these programs can make a big difference in the net profit derived from even a single shipment. The new Voluntary Qualified Importer Program (VQIP) is one such example. Another example is CBP’s and FDA’s implementation of the Automated Commercial Environment (ACE) program, which will become mandatory for importers in 2016. If you fail to correctly use new import procedures and programs, you will be operating under an expensive disadvantage.

Learning Objectives:

  • FDA’s new cost-saving import programs
  • Understand how U.S. Customs and FDA legal requirements intersect
  • Know how to manage foreign suppliers
  • Understand FDA’s internal procedures
  • Learn how to mitigate and resolve import detentions
  • Learn how to avoid common problems
  • Develop practical ways to improve your import and export business
Course Outline:

Day One (8:30 AM – 4:30 PM)

Registration Process: 8:30 AM - 9:00 AM

Session Start Time: 9:00 AM

Day 1 / Morning

FDA’s legal requirements

Statutory authority
Regulations
Foreign manufacturers obligations
U.S. initial importers obligations
User Fees
How does FDA do its job
What is CPB and how do they do their job
Selecting foreign suppliers

Inspection history
Samples analyzed
Vendor Audit


Day 1 / Afternoon

Product Import Procedures

Entry Process (U.S. Customs/FDA)
How to Pick the right Custom House Broker
Documentation
FDA Form 2877
CPB Form 3461
Medical Device Affirmations of Compliance (AofC)
Electronic Entry Filing
FDA’s PREDICT computer screening program
Product sampling / testing
Detention, block list, automatic detention
Quality standards
Country of origin
Product type
(Case Study)


Day Two (8:30 AM – 4:30 PM)


Day 2 / Morning

Detention

Options for a detained shipment
Negotiating with FDA and U.S. Customs
What to say
What not to say
When to give up
Release from Detention and Government Refusal Remedies
Reducing the risk of detention
(Group study for mitigating detention risks)

Day 2 / Afternoon

Enforcement

U.S. Customs and FDA authority
Burden of proof
Assistant U.S. attorney
Government remedies
Special provisions

Counterfeit
Import for export
International trade shows
Investigational device
“Compassionate Use”
 

Seminar Summary:

The FDA continues to change its import program to better manage new problems and to use new procedures to make the whole process easier. (see full course description)

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