2-Day In-Person Seminar by Ex-FDA Official

Preparing for FDA's New Import/Export Trauma in 2020

BY: Casper E. Uldriks,

Former Associate Center Director of FDA's CDRH

December 12-13, 2019
Chicago, IL
  • Course Description
  • Agenda
  • Speaker
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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. When and how you use these programs can make a big difference in the net profit derived from even a single shipment. The new Voluntary Qualified Importer Program (VQIP) is one such example. Another example is CBP’s and FDA’s implementation of the Automated Commercial Environment (ACE) program became mandatory for importers in 2016. If you fail to correctly use new import procedures and programs, you will be operating under an expensive disadvantage.

You will be able to answer the following questions with this course without saying, “I don’t know?”

  • What are the FDA’s import legal requirements and policy?
  • 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?
  • How do you inter-act with the FDA to work out problems?
  • Why are import and export rules different or does it even matter?

Seminar Instructor Casper Uldriks is an "Ex-FDA Official" who has spent 32 years in FDA and his engagements focus on advertising and promotion, recalls, corrections and removals and enforcement. He currently trains FDA personnel and counsels clients on wide range of topics, including: FDA inspections; import operations; advertising and promotion; corrective and preventive actions; medical device reporting and corporate reorganization to improve conformance to the FDA’s requirements.

Learning Objectives:
  • 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
  • Develop practical ways to improve your import and export business
  • You will be able to answer the following questions with this course without saying, “I don’t know?”
  • What are the FDA’s import legal requirements and policy?
  • 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?
  • How do you inter-act with the FDA to work out problems?
  • Why are import and export rules different or does it even matter?
Who will Benefit:

The FDA’s regulatory controls for imported and exported devices have become increasingly pervasive and stringent. Foreign manufacturers, foreign exporters and domestic initial importers face greater scrutiny and are subject to expensive consequences if they do not plan carefully. Attendees need to understand the FDA’s and the US Customs Border Patrol’s regulatory criteria, inter-agency agreements and intra-agency procedures. The conference provides attendees with the opportunity to understand their work’s inter-relationship with other attendees’ roles.

  • 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
Day 01(8:30 AM - 4:30 PM)
  • 8:30 – 9:00 AM: Registration
  • Day 1 – Morning
  • FDA’s legal requirements
    • Statutory authority
    • Regulations
  • Foreign manufacturers obligations
    • U.S. initial importers obligations
    • User Fees
    • How does FDA do its job
    • What is CPB and how do they do their job
  • Selecting foreign suppliers
    • Inspection history
    • Samples analyzed
    • Vendor Audit
  • Day 1 / Afternoon
  • Product Import Procedures
    • Entry Process (U.S. Customs/FDA)
    • How to Pick the right Custom House Broker
    • Documentation
      • FDA Form 2877
      • CPB Form 3461
      • Medical Device Affirmations of Compliance (AofC)
      • Electronic Entry Filing
        • FDA’s PREDICT computer screening program
        • U.S. Customs Automated Commercial Environment (ACE) program
        • Product sampling / testing
        • Detention, block list, automatic detention
      • Quality standards
      • Country of origin
      • Product type
    • (Case Study)

Day 02(8:30 AM - 4:00 PM)
  • Day 2 / Morning
  • Foreign Inspections by the FDA and EU Notified Bodies
  • Detention
    • Options for a detained shipment
    • Negotiating with FDA and U.S. Customs
      • What to say
      • What not to say
      • When to give up
    • Release from Detention and Government Refusal Remedies
    • Reducing the risk of detention
  • (Group study for mitigating detention risks)

  • Day 2 / Afternoon
  • FDA Warning Letters and Automatic Detention
  • Enforcement
    • U.S. Customs and FDA authority
    • Burden of proof
    • Assistant U.S. attorney
    • Government remedies
  • Special provisions
    • Counterfeit
    • Import for export
    • International trade shows
    • Investigational device
    • “Compassionate Use”
  • New and Special Issues for Imports and Exports in 2020.
    • EU Medical Device Regulation (MDR) program for imported products
    • Inspection of personal mail
    • Personal use exception
    • Trade shoes and promotional marketing
    • Compassionate use.
Casper (Cap) Uldriks
Casper (Cap) Uldriks Former Associate Center Director of FDA's 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.

Register Now

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$1,499.00

Seminar One Registration

December 12-13, 2019, Chicago, IL
(For Registrations till November 20, 2019 - $1499)
(For Registrations after November 20, 2019 - $1699)


The registration fee includes: the workshop; all related course materials; tea/coffee and lunch on both the days.
For discounts on multiple registrations, contact customer care at +1-888-771-6965.

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Terms & Conditions to register for the Seminar/Conference/Event

Your Registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-771-6965 or email us @ customercare@fdatrainingalert.com

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Payment is required before 2 days of the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. ( our parent company)

Cancellations and Substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund — less a $300 administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days from the start date of the event.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($300) will be transferred to any future FDATrainingAlert event and a credit note will be issued.

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We discourage onsite registrations, however if you wish to register onsite payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available we will send the material after the conference is over.

In the event FDATrainingAlert cancels the seminar, FDATrainingAlert is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.

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Local Attractions of Chicago, IL

Windy Windy

One of the more breathtaking scenes on the lake is this tall ship approaching the docks at Navy Pier. The 148-foot four-masted schooner (and its new sister ship, the Windy II ) sets sail for 90-minute cruises two to five times a day, both day and evening. (Because the boats are sometimes booked by groups, the schedule changes each week; call first to confirm sailing times). The boats are at the whims of the wind, so every cruise charts a different course. Passengers are welcome to help raise and trim the sails and occasionally take turns at the ship's helm (with the captain standing close by). The boats are not accessible for people with disabilities.

Adler Planetarium and Astronomy Museum Adler Planetarium and Astronomy Museum

The building may be historic (it was the first planetarium in the Western Hemisphere), but some of the attractions here will captivate the most jaded video-game addict.
Your first stop should be the modern Sky Pavilion, where the don't-miss experience is the StarRider Theater. Settle down under the massive dome, and you'll take a half-hour interactive virtual-reality trip through the Milky Way and into deep space, featuring a computer-generated 3-D-graphics projection system and controls in the armrest of each seat. Six high-resolution video projectors form a seamless image above your head -- you'll feel as if you're literally floating in space. If you're looking for more entertainment, the Sky Theater shows movies with an astronomical bent; recent shows have included Secrets of Saturn and Mars Now!

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Art Institute of Chicago Art Institute of Chicago

You can't -- and shouldn't -- miss the Art Institute. (You really have no excuse, since it's conveniently located right on Michigan Ave. in the heart of downtown.) No matter what medium or century interests you, the Art Institute has something in its collection to fit the bill. Japanese ukiyo-e prints, ancient Egyptian bronzes, Greek vases, 19th-century British photography, masterpieces by most of the greatest names in 20th-century sculpture, and modern American textiles are just some of the works on display, but for a general overview of the museum's collection, take the free "Highlights of the Art Institute" tour Saturday and Sunday.

Auditorium Building and Theatre Auditorium Building and Theatre

A truly grand theater with historic-landmark status, the Auditorium gives visitors a taste of late-19th-century Chicago opulence. Because it's still a working theater -- not a museum -- it's not always open to the public during the day; to make sure you'll get in, schedule a guided tour, which are offered on Mondays at 10am and noon.
Designed and built in 1889 by Louis Sullivan and Dankmar Adler, the 4,000-seat Auditorium was a wonder of the world: the heaviest (110,000 tons) and most massive modern edifice on earth, the most fireproof building ever constructed, and the tallest building in Chicago. It was also the first large-scale building to be lit by electricity, and its theater was the first in the country to install air-conditioning. Originally the home of the Chicago Opera Company, Sullivan and Adler's masterpiece is defined by powerful arches lit by thousands of bulbs and features Sullivan's trademark ornamentation -- in this case, elaborate golden stenciling and gold plaster medallions. It's equally renowned for otherworldly acoustics and unobstructed sightlines.

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