2 Day Seminar on Coping with FDA Import Delays, including COVID-19, Expedited Imports and Detentions (August 12-13, 2021) - ResearchAndMarkets.com

·3 min read

DUBLIN, Jun 11, 2021--(BUSINESS WIRE)--The "Coping with FDA Import Delays, including COVID-19, Expedited Imports and Detentions" training 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 PDT)

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 PDT)

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 shoes and promotional marketing

  • Compassionate use.

For more information about this training visit https://www.researchandmarkets.com/r/71zw4n

View source version on businesswire.com: https://www.businesswire.com/news/home/20210611005284/en/

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