FDA's New Import Program for 2017 - Two Day Programme (Philadelphia, PA, United States - August 24-25, 2017)

Dublin, April 18, 2017 -- Research and Markets has announced the addition of the "FDA's New Import Program for 2017 - Strict Precision" conference to their offering.

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 problems.

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

Who Should Attend:

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.

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
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

For more information about this conference visit http://www.researchandmarkets.com/research/lcf8pd/fdas_new_import

CONTACT: Research and Markets
         Laura Wood, Senior Manager
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         Related Topics: Pharmaceuticals