FDA New Import Program for 2017 – Strict Precision (COM)


FDA New Import Program for 2017 – Strict Precision (COM)
Event on 2017-06-22 08:30:00
DESCRIPTION

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.
Download Brochure

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”

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.

Please contact the event manager Marilyn below for the following:
– Discounts for registering 5 or more participants.
– If you company requires a price quotation.
Event Manager Contact: marilyn.b.turner(at)nyeventslist.com
You can also contact us if you require a visa invitation letter, after ticket purchase.
We can also provide a certificate of completion for this event if required.

—————————————————————–
This Event Listing is Promoted by
New York Media Technologies LLC in association
with METRICSTREAM INC.
http://www.NyEventsList.com
http://www.BostonEventsList.com
http://www.SFBayEventsList.com
—————————————————————–

EDA170512EFUL

at San Francisco, California, United States
San Francisco, California, United States
San Francisco, United States

Leave a comment