ComplianceOnline

FDA Import Alert - 2017

Instructor: Casper Uldriks
Product ID: 705323
  • 18
  • July 2017
    Tuesday
  • 10:00 AM PDT | 01:00 PM EDT
    Duration: 60 Min

Live Online Training
July 18, Tuesday 10:00 AM PDT | 01:00 PM EDT | Duration: 60 Min

$199.00
One Dial-in One Attendee
$499.00
Group-Max. 10 Attendees/Location
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Get CD free on purchase of Group ticket

recorded version

$249.00
1x Person - Unlimited viewing for 6 Months
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Recorded Link and Ref. material will be available in My CO Section 48 hrs after completion of Live training

Training CD

$349.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days after completion of Live training

Combo Offers

Live + Recorded Version

$349.00

Live + Training CD

$399.00

Customer Care

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Read Frequently Asked Questions

This webinar will cover US FDA and Customs legal import requirements including discussion on FDA product codes, Custom's Harmonized Tariff Schedule (HTS) and Affirmation of Compliance (AOC). It will also provide information on FDA's software screening program, PREDICT, and U.S. Custom's ACE program.

Why Should You Attend:

The new import entry filing requirements became effective in 2016 and are posing problems for user. Failure to provide the correct information creates costly delays and, in some cases, the frustrating task of contacting the FDA to resolve the problem. FDA's software screening program, PREDICT, and U.S. Custom's ACE program require careful attention. Errors will cost money. The less obvious software is the FDA's and U.S. Custom's linking of your legal requirements by using the correct Harmonized Tariff Schedule (HTS) code. That sets up how FDA will apply its requirements. In addition, the information on the manifest, invoice and affirmation of compliance make importing easy provided you get it right. Making errors means FDA may flag you as a problem that requires greater scrutiny for data verification. As if delays and detentions are not bad enough, there will be punitive fines for filing incorrect entry data in ACE. This is a needless cost as long as you understand what you should be doing.

The benefits require the correct information for FDA and U.S. Customs software programs. At least now, using the PREDICT and ACE programs let you check the status of your entry and what the communications are between your broker and U.S. Customs. There is a lot of information at your fingertips now, if you get it right.

Areas Covered in the Webinar:

  • 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)

Who Will Benefit:

  • 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
Instructor Profile:
Casper Uldriks

Casper Uldriks
Former Associate Center Director, CDRH

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.

Topic Background:

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.

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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

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