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FDA's New Import Program for 2019 - Strict Precision (COM)

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FDA's New Import Program for 2019 - Strict Precision (COM)


FDA's New Import Program for 2019 - Strict PrecisionThe 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


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 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    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    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”


SpeakerCasper (Cap) UldriksFormer Associate Center Director of FDA's CDRHCasper (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.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





Please contact the event manager Marilyn (marilyn.b.turner(at)nyeventslist.com ) below for:- Multiple participant discounts- Price quotations or visa invitation letters- Payment by alternate channels (PayPal, check, Western Union, wire transfers etc)- Event sponsorshipsNO REFUNDS/TRANSFERS ALLOWED ON REGISTRATIONSPrices may go up any time. Service fees included in pricing.-----------------------------------------------------------------This event is brought to you by:ComplianceOnline.com - NewYorkEventsList http://www.NyEventsList.com http://www.BostonEventsList.com http://www.SFBayEventsList.com-----------------------------------------------------------------


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