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
Website or Map: https://goo.gl/o89jxC
Event Type: online, webinar
Organized By: Training Doyens
Latest Activity: Mar 13, 2018
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.
WHY SHOULD YOU ATTEND
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.
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.
WHO WILL BENEFIT
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:
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