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Who should attend FDA's New Import Program for 2018 - Strict Precision
Business Planning Executives, Regulatory Managers, In-house Legal Counsel and Contract Specialists, Venture Capitalists, Business Acquisition Executives, Owners of New or Developing Import/Export Firms, International Trade Managers
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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 for 2017 - Strict Precision

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 became 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
You will be able to answer the following questions with this course without saying, “I don’t know?”
What are the FDA’s import legal requirements and policy?
How do you deal with the FDA and the U.S. Customs and Border Patrol procedures?
What happens when your product is detained?
What happens if a foreign manufacturer is in trouble with the FDA?
How do you inter-act with the FDA to work out problems?
Why are import and export rules different or does it even matter?

Topic Background:

FDA’s import and export program is complex and keeps changing. The FDA’s and the U.S. Custom’s new import and enforcement program operates with a streamlined computer system and can leave firms at a loss to understand the short term and long term effects of a detained shipment. The law now requires foreign firms to register and submit specific information to enter U.S. commerce.

Foreign establishments are subject to FDA inspections and quality testing. Failing either FDA activity typically prevents a foreign firm’s product from entering U.S. commerce. If product is detained, resolving the problem with FDA is time consuming, expensive and uncertain. Without an adequate or informed approach to your import program, the specialized federal government process and roadblocks can seem impossible to overcome. To compound the problems, working with foreign establishments presents inherent difficulties based on cultural differences business practices and language barriers.

Day 01(8:30 AM - 4:30 PM)


08.30 AM - 09.00 AM: Registration
09.00 AM: Session Start
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
U.S. Customs Automated Commercial Environment (ACE) program
Product sampling / testing
Detention, block list, automatic detention
Quality standards
Country of origin
Product type

(Case Study)

Day 02(8:30 AM - 4:00 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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