Overview:
The 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. 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. FDA offers some relief from the strict requirements if you participate in a voluntary Affirmation of Compliance (AOC). Providing accurate information is necessary in order to reconcile the PREDICT, ACE, Invoice and AOC information. Your failure to accomplish these tasks can lead to smooth sailing or to a whirlpool of costly delays and fines. Time is not on your side during the import process. Time is money; the more you use, the more you lose.
The 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. 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. FDA offers some relief from the strict requirements if you participate in a voluntary Affirmation of Compliance (AOC). Providing accurate information is necessary in order to reconcile the PREDICT, ACE, Invoice and AOC information. Your failure to accomplish these tasks can lead to smooth sailing or to a whirlpool of costly delays and fines. Time is not on your side during the import process. Time is money; the more you use, the more you lose.
Speaker
Casper (Cap) Uldriks, through his firm "Encore Insight LLC," brings over 32 years of experience from the FDA. He specialized in the FDA's medical device program as a field investigator, served as a senior manager in the Office of Compliance and an Associate Center Director for the Center for Devices and Radiological Health.He developed enforcement actions and participated in the implementation of new statutory requirements. His comments are candid, straightforward and of practical value. He understands how FDA thinks, how it operates and where it is headed.
Based on his exceptionally broad experience and knowledge, he can synthesize FDA's domestic and international operational programs, institutional policy and thicket of legal variables into a coherent picture. Professional credentials: JD - Suffolk University, licensed in Massachusetts and the District of Columbia; M.Div in psychology - Boston University with internship through Harvard University.
Who Should Attend
- 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
