Objectives of the Presentation:
FDA’s import program has become complex and sophisticated. A successful import business requires a working knowledge of critical import requirements and what to do when a requirement is not met.
You will learn what the FDA regulatory hurdles are, how they work and how you can work with them in an efficient and effective way. You will also learn how the U.S. Customs and Border Patrol and FDA work in tandem.
Areas Covered:
· How FDA prioritizes inspection assignments
· How FDA prepares for inspections
· A firm’s logistical preparation of an inspection
· How to inter-act with the FDA on-site
· How to respond to problems “observed” by FDA or a Warning Letter
· How to manage import refusals and detentions
Who will benefit:
· Foreign manufacturers and holding companies
· Foreign exporters
· U.S. Initial Importers
· U.S. Customs Import Brokers
· International FDA regulatory affairs managers
· Financial planning managers
· Sales and Marketing managers
Why you should attend:
FDA’s import operation uses strict controls to manage products offered for entry into the U.S. FDA’s application of manufacturing regulations, information, documentation and risk mitigation strategies play a central role that you can manage if you understand it. If you do not understand FDA import requirements, it becomes a very expensive and time consuming learning curve. FDA’s inspections play a make-or-break role for firm’s that plan to start or continue to do business in the U.S. Once a firm gets into rocky regulatory territory, it is very hard to get back on a clear track.
Casper 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 an Associate Center Director for the Center for Devices and Radiological Health. He developed enforcement actions, 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.)
Live Session for one participant
Price: $225.00
Corporate Live Session 4 to 10 participants in single location.
Price:$885.00
Recorded Session Access recorded sessions only for one participant unlimited viewing for 6 months.
Price: $275.00