FDA’s Tougher Import Program in 2018

Product Id IQS18K1016
Speaker Casper Uldriks
Level Basic & Intermediate
Timings 09:00 AM TO 04:30 PM CST
Scheduled Date(s) Thursday, November 15, 2018 to Friday, November 16, 2018 ( 2 Days )
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Background:

The FDA continues to change its import program to better manage new problems and to use new procedures to make the process more efficient.  The FDA and U.S. Customs and Border Protection (CBP) now require the use of computers to submit entry data.  The programs interact in real time.  When and how you manage the computer programs, makes a significant difference in the success of your import operations and net profits.  When you get into trouble, you must know what to do. Time is not on your side and FDA’s decision cannot be appealed. 

Description:

FDA’s import and export programs are complex, detailed and undergo changes without notice to the public.  The FDA’s and CBP’s new import and enforcement program operates with remarkably efficient software systems that can leave a firm scrambling for a resolution and end up suffering the expensive consequences of a detention.  The information data base used by the FDA includes extensive information from foreign suppliers.  If that is not in order, your shipment will not be permitted entry, in some cases even before the products can be loaded onto the vessel or before it arrives at the port.

Foreign establishments are subject to the same manufacturing regulations as U.S. firms.  There are inherent problems with foreign commerce, such as language and cultural differences.  If a foreign firm’s manufacturing operation or its products fail any criteria, a detention, or even worse, a refusal becomes your next crisis.  If your product is detained, you must now how to try and resolve the problem with the FDA.  You have only ten days to figure out your plan and have FDA agree, which as not a given. On day 11, your product must either be destroyed or exported. 

FDA offers special programs to automatically release entries provided pre-qualification criteria are met.  This is especially valuable to importers of perishable goods.

Import/export requirements can be confusing and costly if you do not understand the legal requirements.  You need clarity, accurate knowledge and solid business procedures to succeed.

  • Understand how FDA and CBP legal and administrative requirements intersect
  • You can understand FDA’s legal requirements and somewhat esoteric policies
  • Understand FDA’s internal procedures for import operations
  • Learn how to mitigate and resolve import detentions
  • Learn how to avoid common problems
  • Develop practical ways to improve your import and export business
  • Learn how to interact with FDA and follow their procedures
  • Learn what happens to your if a foreign supplier is in trouble with FDA
  • Understand FDA export rules
  • Understand the import for export requirements
  • FDA’s legal authority and evidence threshold
  • Information required by FDA, CBP and the U.S. Census Bureau
  • FDA’s entry evaluation procedures
  • Resolving import detentions
  • Foreign supplier requirements
  • Products returned for repair
  • Imports of bulk pharmaceuticals, investigational products and research products
  • Export requirements and certificates
  • Import-for-export requirements

AGENDA

Day 1 (8:30 AM – Registration)

Day 02 (9:30 AM - 4:00 PM)

Morning (9:00 – 12:00 PM)

  • FDA’s legal requirements Customs and FDA Joint Computer Programs
  • FDA Information Requirements
  • Automated Commercial Environment (ACE) Program

 Coffee Break in session

Morning (9:30 AM – 12:00 PM)

  • Import Detention
  • FDA Sample Collection and Field Exams
  • Resolving Initial Detention
  • Import Alerts
  • Foreign Inspections

Coffee Break in session

Lunch 12:00 PM – 1:00 PM

Lunch 12:00 PM – 1:00 PM

Afternoon (1:00 PM – 4:30)

  • Customs and Border Protection   Information Requirements
  • FDA Information Submission for Product Entry
  • Investigational Drugs
  • Import Brokers
  • Interagency Import Process
  • American Goods Returned
  • Return for Repair 

Coffee Break in session

Afternoon (1:00pm – Onwards)

  • Foreign Inspections (continued)
  • FDA Warning Letters and Legal Action
  • Exports Options
  • Requirements
  • Export Certificates
  • Import-for-Export
  • Special Topics 

 

Coffee Break in session

End of Day

End of Seminar

Location: Chicago, IL 

Venue: To be Decided

  • Business Planning Executives
  • Regulatory Directors
  • In-house Legal Counsel and Contract Specialists
  • Venture Capitalists
  • Business acquisition Managers
  • Owners of New or Developing Import/Export Firms
  • International Trade and Logistics Managers
  • Import Brokers
  • Investors
  • Sales Managers 

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.

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