The FDA and U.S. Customs and Border Protection have implemented strict import requirements. Importers must provide precise information to make it through FDA’s software screening program (PREDICT) and likewise, through U.S. Custom’s ACE software program. Errors here can cost you long delays and fines. In the event your product is detained, you face another major delay. If you do not understand the detention process and the need for prompt action, the product will be refused and must be exported or destroy. During a detention, you can negotiate with the FDA, but you have to know the procedures and some tips. The ultimate delay involves Import Alerts, which brings your U.S. import business to a halt, especially if the FDA identifies the foreign manufacturer by name on the Import Alert. Dealing with an Import Alert is complicated, expensive and time consuming.
You will learn FDA’s import requirements, procedures and tips on how to work with the FDA. For example:
• FDA’s required information for the PREDICT software screening prior to entry
• Custom’s required information for the ACE software system prior to entry
• FDA product codes and supplemental process code information
• Import holds, what they mean and what happens
• Detentions, what you must do quickly or lose
• Refusals, what your options are
• Negotiating with the FDA
• Import Alerts (3 types)
• Consequences of an Import Alert for foreign manufactures
• Foreign manufacturer Warning Letters
• Business strategy around Import Alerts
Participants should be familiar with basic U.S. import operations, FDA regulated products and U.S. Customs and Border Protection’s role. Participants should also have a basic awareness of FDA’s domestic and foreign operations.
Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment
Recorded video session
Casper (Cap) Uldriks, through his firm "Encore Insight LLC," 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 Radio-logical Health. He developed enforcement actions and participated in the implementation of new statutory requirements. His comments are candid, straightforward and of practical value. He understands how FDA thinks, how it operates and where it is headed. Based on his exceptionally broad experience and knowledge, he can synthesize FDA's domestic and international operational programs, institutional policy and thicket of legal variables into a coherent picture.