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FDA's New Import Program for 2018 – Are you prepared?

Event Details

FDA's New Import Program for 2018 – Are you prepared?

Time: March 26, 2018 from 1pm to 2pm
Location: 26468 E Walker Dr, Aurora, Colorado 80016-6104
Street: 26468 E Walker Dr, Aurora, Colorado 80016-6104
City/Town: Aurora
Website or Map:
Phone: 7209961616
Event Type: online, webinar
Organized By: Training Doyens
Latest Activity: Mar 13

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Event Description


FDA and U.S. Customs and Border Protection are using new import requirements.The FDA’s import software screening program (PREDICT) and the U.S. Custom’s ACE software program require more information from the foreign source(s). FDA’s product codes and U.S. Harmonized Tariff Schedule (HTS) link the requirements. Take away is that the software coding information must be correct. Otherwise, you face costly delays and possibly a refusal of the entry. In addition, information on the entry’s commercial or pro forma invoice must be consistent with the information entered into PREDICT and ACE software. All products regulated by the Food and Drug Administration must meet the same requirements, whether imported from abroad or produced domestically. 


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. The new import entry filing requirements became effective in 2016 and is posing problems for the user. Failure to provide the correct information creates costly delays.


  • FDA’s required information for the PREDICT software screening prior to entry
  • FDA product codes
  • Custom’s required information for the ACE software system prior to entry
  • Custom’s Harmonized Tariff Schedule (HTS) 
  • Affirmation of Compliance (AOC)
  • 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
  • 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?


The webinar focuses on FDA's software screening program, PREDICT, and U.S. Custom's ACE program that require careful attention for being prepared and compliant.


This webinar will provide a valuable and informative overview and guidance to manufacturers, especially medical device companies and biopharmaceutical companies preparing for FDA inspections. The employees who will benefit include: 

  • All levels of management and departmental representatives and any anyone who desires a better understanding of the new program from end-to-end and the ground rules 
  • Legal Counsel
  • Regulatory Management
  • Regulatory SME
  • Regulatory Affairs/RA Specialists
  • Purchasing 
  • Quality
  • Auditors
  • Compliance
  • Technical Services/Operations
  • Project Managers
  • Consultants
  • 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
  • Import Brokers
  • Investors
  • Logistics Managers
  • Sales Managers


For more detail please click on this below link:



Toll Free: +1-888-300-8494

Tel: +1-720-996-1616

Fax: +1-888-909-1882

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