FDA's and the U.S. Customs Border Patrol's Import

Events in California

FDA's Import and Export Control Program

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DoubleTree by Hilton Hotel Los Angeles Downtown

120 South Los Angeles Street, Los Angeles

Los Angeles, California 90012

This Seminar is Pre- approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

http://bit.ly/FDA-Import-and-ExportControlProgram

Overview:

FDA's and the Customs and Border Patrol Service (CBP) has become increasingly sophisticated and equally demanding in the submission of information and adherence to government procedures. Firm's that fail to understand and properly execute an import and export program find that their shipment is delayed, detained or refused. A number of factors can derail the expectation of a seamless import process. The course covers detailed information about the roles and responsibilities of the various parties involved with an import operation and how to correct the weakest link(s) in the commercial chain. The course will include tips on how to understand FDA's thinking and offer anecdotal examples of FDA's import program curiosities.

Why should you attend?

What happens when your product is detained? FDA will begin a legal process that can become an expensive business debacle. You must respond fully within short timeframes. This is not the time for you to be on a learning curve. You need to have a plan in place and know what you are doing.

The FDA is steadily increasing the legal and prior notice information requirements. If you do not know what those requirements are and you initiate a shipment, your product is figuratively dead in the water. You must be accurate with the import coding information and understand the automated and human review process. If not, you can expect detained shipments.

What happens when FDA decides you should bring the products back to the port of entry after you received a release but you cannot locate the product that has been sold? CBP may fine you three times the value of the shipment. FDA may have other adverse legal concerns and strategies.

When products are refused, you have different options. Some options may cost more than others. For example, your product may be destroyed by the government. You may be fined if you do not act in a timely manner.

These are common problems that become prohibitively expensive. You should know how to avoid common problems or at least how to mitigate the cost by using established and effective business planning.

Course Outline:

Day One:

9:00 AM - 10:30 AM

· FDA Import History and Legal Authority

· Customs and Border Control (CBP) Import Process

· FDA Import Process

10:30 AM - 10:45 AM

Break

10:45 AM - 12:00 PM

· FDA Import Process (continued)

o Import Brokers

o Prior Notice Information

12:00 PM - 1:00 PM

Lunch

1:00 PM - 2:45 PM

· FDA Import Process (continued)

o Import Codes

o Bonds and Bonded Warehouses

o FDA "Notice of Action"

2:45 PM - 3:00 PM

Break

3:00 PM - 5:00 PM

· Import Detention ( 5 Minute Break )

· Import Delays

· Import Alerts

Day Two:

9:00 AM - 10:30 AM

· Foreign Inspections

· FDA 483 - Inspectional Observations

10:30 AM - 12:00 PM

FDA Warning Letters

12:00 PM - 1:00 PM

Lunch

1:00 PM - 2:45 PM

· Import Hypothetical

· FDA Import for Export Program

· FDA Export Program

· Export Hypothetical

2:45 PM - 3:00 PM

Break

3:00 PM - 5:00 PM

· FDA Export Program ( 5 Minute Break )

· Special Import Issues

o Trade Shows

Who Will Benefit:

· Domestic importers

· Foreign exporter

· Initial importers

· International trade executives

· Venture Capitalists

· Marine insurance underwriters

· Import Brokers

· Regulatory affairs managers

· Import / Export consultants

· In-house counsel

· Contract specialists

· Logistics managers

· Third party establishment inspection entities

· Sales managers

· Investors

ABOUT SPEAKER –

Casper Uldriks

Ex-FDA Expert and former Associate Center Director of CDRH, Olsson Casper (Cap) Uldriks 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 as 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. He is recognized as an exceptional and energetic speaker. His comments are candid, straight forward and of practical value. He understands how FDA thinks, operates and where it is headed. Cap now works almost exclusively on medical device issues at Olsson, Frank and Weeda (OFW Law in Washington, D.C.

Location: Los Angeles, CA Date: August 21st & 22nd, 2014 Time: 9 AM to 5 PM