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


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      December 12, 2019

      Thursday   8:30 AM - 3:30 PM

      8 West Root Street
      Chicago, Illinois 60609

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

      Preparing for FDA's New Import / Export Trauma in 2020
      About this Event
      *** LIMITED TIME OFFER: FREE $100 AMAZON GIFT CARD! *** REGISTER TODAY!

      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.

      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?
      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.

      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
      Seminar Fee Includes:

      Lunch

      AM-PM Tea/Coffee

      Seminar Material

      USB with seminar presentation

      Hard copy of presentation

      Attendance Certificate

      $100 Gift Cert for next seminar

      Topic Background:

      FDA’s import and export program is complex and keeps changing. The FDA’s and the U.S. Custom’s new import and enforcement program operates with a streamlined computer system and can leave firms at a loss to understand the short term and long term effects of a detained shipment. The law now requires foreign firms to register and submit specific information to enter U.S. commerce.

      Foreign establishments are subject to FDA inspections and quality testing. Failing either FDA activity typically prevents a foreign firm’s product from entering U.S. commerce. If product is detained, resolving the problem with FDA is time consuming, expensive and uncertain. Without an adequate or informed approach to your import program, the specialized federal government process and roadblocks can seem impossible to overcome. To compound the problems, working with foreign establishments presents inherent difficulties based on cultural differences business practices and language barriers.

      Other foreign and domestic and legal requirements intersect with FDA’s import and export program, some for the better, some not. For example, not all foreign firms are treated the same under the FDA’s law. A clear example is the FDA’s uses of automatic detention based on the country of origin, type of product or an establishment’s history. With the growing use of off-shore operations, managing imported products can and does present obvious and hidden

      AGENDA

      DAY 01(8:30 AM - 4:30 PM)

      08.30 AM - 09.00 AM: Registration

      09.00 AM: Session Start

      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.

      SPEAKER

      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.

      Cost: $1,899

      Categories: Conferences & Tradeshows

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