Final Week to Register for the Two Day Virtual FDA Import Training Course: Coping with FDA Import Delays, including COVID-19, Expedited Imports and Detentions (January 20-21, 2022)

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Jan 14, 2022, 06:45 ET

DUBLIN, Jan. 14, 2022 /PRNewswire/ -- The "Coping with FDA Import Delays, including COVID-19, Expedited Imports and Detentions" training course has been added to ResearchAndMarkets.com's offering.

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 interact with the FDA to work out problems?
Why are import and export rules different or does it even matter?

Key Topics Covered:

Day 01 (8:30 AM - 2:30 PM PST)8.30 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 - 2:30 PM PST)

Day 2 - Morning

Foreign Inspections by the FDA and EU Notified Bodies

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

FDA Warning Letters and Automatic Detention

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"

New and Special Issues for Imports and Exports in 2020.

EU Medical Device Regulation (MDR) program for imported products
Inspection of personal mail
Personal use exception
Trade shows and promotional marketing
Compassionate use.

For more information about this training visit https://www.researchandmarkets.com/r/6c2se7

Media Contact:

Research and Markets
Laura Wood, Senior Manager
[email protected]

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SOURCE Research and Markets