ComplianceOnline

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

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

In-Person Seminar going Virtual with increased learner satisfaction.

Yes, attend this seminar from anywhere. We are making it real and more interactive – Here's a sneak peek:

Our enhanced delivery process and technology provides you an immersive experience and will allow you to access:

  • The real-time and live presentation as in in-person events
  • Private chat for company-specific conversation – the same as you would get in an in-person seminar
  • Opportunities to connect with your peers to share knowledge at a different time and have group discussions
  • Live workshop activities
  • Live Q&A during the event and offline Q&A assistance after the event
  • As usual more content, activities and case studies and now adding homework for a comprehensive understanding
  • Certification
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
Day 01(8:30 AM - 2:30 PM PDT)
  • 8.30 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 - 2:30 PM PDT)
  • 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.
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
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 by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure

Register Now

Online using Credit card

$1,499.00

(One Dial-in One Attendee)

November 17-18, 2020, Virtual Seminar
(For Registrations till August 10, 2020 - $1499)
(For Registrations after August 10, 2020 - $1899)

$7,645.00

Group-Max. 10 Attendees

November 17-18, 2020, Virtual Seminar
(For Registrations till August 10, 2020 - $7645)
(For Registrations after August 10, 2020 - $9999)



Other Registration Option

By order form / PO#

Payment Mode

By Check -
Pay your check to (payee name) “MetricStream Inc” our parent company and Mail the check to:

ComplianceOnline (MetricStream, Inc),
2479 E. Bayshore Road Suite 260
Palo Alto, CA 94303
USA

By Wire -

Register / Pay by Wire Transfer

Please contact us at +1-888-717-2436 to get details of wire transfer option.

Note: In view of Coronavirus situation and travel advisory issued, ComplianceOnline will waive off all cancellation charges for the registrations till August 15, 2020.

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 @ +1-888-717-2436 or email us @ customercare@complianceonline.com

Payment:

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

Cancellations and substitutions for In-person Seminars:

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 before 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 ComplianceOnline event and a credit note will be issued.

Substitutions may be made at any time. No-shows will be charged the full amount.

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 ComplianceOnline cancels the seminar, ComplianceOnline 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.

Cancellations and Substitutions for Virtual Seminars & Webinars:

Written cancellations through fax or email (from the person who has registered for the training) received at least 10 calendar days prior to the start date of the event will receive a refund — less a 30% 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 training) a credit for the amount paid minus administration fees (30%) will be transferred to any future ComplianceOnline event and a credit note will be issued. Substitutions may be made at any time. No-shows will be charged the full amount. Some topics and speakers may be subject to change without notice.
Offers:
  • Early bird seats are limited and based on first-come, first-serve.
  • Multiple offers cannot be combined.
  • Online using Credit card

    $1,699.00

    (One Dial-in One Attendee)

    (After registration, we will video stream the training on your convenient dates)

    $9,799.00

    Group-Max. 10 Attendees

    (After registration, we will video stream the training on your convenient dates)



    Other Registration Option

    By order form / PO#

    Payment Mode

    By Check -
    Pay your check to (payee name) “MetricStream Inc” our parent company and Mail the check to:

    ComplianceOnline (MetricStream, Inc),
    2479 E. Bayshore Road Suite 260
    Palo Alto, CA 94303
    USA

    By Wire -

    Register / Pay by Wire Transfer

    Please contact us at +1-888-717-2436 to get details of wire transfer option.

    Note: In view of Coronavirus situation and travel advisory issued, ComplianceOnline will waive off all cancellation charges for the registrations till August 15, 2020.

    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 @ +1-888-717-2436 or email us @ customercare@complianceonline.com

    Payment:

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

    Cancellations and substitutions for In-person Seminars:

    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 before 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 ComplianceOnline event and a credit note will be issued.

    Substitutions may be made at any time. No-shows will be charged the full amount.

    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 ComplianceOnline cancels the seminar, ComplianceOnline 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.

    Cancellations and Substitutions for Virtual Seminars & Webinars:

    Written cancellations through fax or email (from the person who has registered for the training) received at least 10 calendar days prior to the start date of the event will receive a refund — less a 30% 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 training) a credit for the amount paid minus administration fees (30%) will be transferred to any future ComplianceOnline event and a credit note will be issued. Substitutions may be made at any time. No-shows will be charged the full amount. Some topics and speakers may be subject to change without notice.
    Offers:
  • Early bird seats are limited and based on first-come, first-serve.
  • Multiple offers cannot be combined.
  • We need below information to serve you better

    Best Sellers
    You Recently Viewed
      Loading