Course Description:

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.

Course Objective:

You will learn FDA’s import requirements, procedures and tips on how to work with the FDA.  For example:

• Learn what information and software codes are required by FDA and U.S. Customs for the PREDICT software screening program and ACE software data requirements.  You will understand how the FDA’s and U.S. Custom’s computer programs work as an integrated system.
• Understand the import hold and detention process and how you can possibly resolve the problem by negotiating with the FDA.
• Know what an Import Alert is; what it means for your business and figure out a realistic business outcome plan.
• Hear some tips on how to make your import business less irritating or, in some cases, traumatic.

Course Outline:

• 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

Target Audience:

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.

• Regulatory Directors for International Trade
• Compliance Managers (FDA/Customs)
• Freight Forwarders
• Foreign Manufacturers/Exporters
• Initial Importer in the U.S.
• Small business owners