Tougher Import Rules for FDA Imports in 2016
Course "Tougher Import Rules for FDA Imports in 2016" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant´s RAC recertification upon full completion.
Overview: FDA´s and the Customs and Border Patrol Service (CBP) have 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. In 2016 entries must use the Automated Commercial Environment (ACE) entry filing system or face entry refusals and monetary penalties up to $10,000 per offense. A number of other factors can derail the expectation of a seamless import process. The course covers detailed information about the roles and responsibilities of the various parties 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. CBP is implemented a new "Automated Commercial Environment" computer program that changes import logistics and information reporting for FDA regulated products. Your shipment may be stopped before it is even loaded at the foreign port.
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 can be seized and 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.
Day 1Lecture 1: FDA Legal Authority Customs and Border Control (CBP) Import Process FDA Import Process Registration and documentation
Lecture 2: FDA Import Process (continued)
• Import Brokers
• Prior Notice Information
• CBP and FDA computer programs
• Import Codes
• Bonds and Bonded Warehouses
• FDA "Notice of Action"
Lecture 3: Import Delays Import Alerts Detention Refusals
Day 2 Schedule:
Lecture 1: Foreign Inspections FDA 483 - Inspectional Observations
Lecture 2: FDA Warning Letters and Automatic detention
Lecture 3: Import Hypothetical FDA Import for Export Program FDA Export Program Export Hypothetical
Lecture 4: FDA Export Program Special Import Issues
• Trade Shows
• Personal Use
• Compassionate Use
ex-FDA Expert and former Associate Center Director of CDRH
Casper (Cap) Uldriks owns Encore Insight LLC, which provides consulting services on FDA Law. He 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, straightforward and of practical value. He understands how FDA thinks, operates and where it is headed.