use this promo code GCP50 to get 50% off. 1 ATTENDEE $2,000. Regular Price: $2000. Register for 1 a...
Sale Date Ended
Course "Tougher Import Rules for FDA Imports in 2019" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
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.
Who Will Benefit:
FDA Legal Authority Customs and Border Control (CBP) Import Process FDA Import Process Registration and documentation
FDA Import Process (continued)
Import Delays Import Alerts Detention Refusals
Foreign Inspections FDA 483 - Inspectional Observations
FDA Warning Letters and Automatic detention
Import Hypothetical FDA Import for Export Program FDA Export Program Export Hypothetical
FDA Export Program Special Import Issues
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.
Location: Washington, DC Date: April 4th & 5th, 2019 and Time: 9:00 AM to 6:00 PM
Venue: Courtyard Arlington Crystal City/Reagan National Airport, 2899 Jefferson Davis Hwy, Arlington, VA 22202, USA
1 ATTENDEE $2,000, Register for 1 attendee
5 ATTENDEES $10,000, Register for 5 attendees
10 ATTENDEES $20,000, Register for 10 attendees
Until March 10, Early Bird Price: $2,000.00
From March 11 to April 02, Regular Price: $2,200.00