The webinar address the critical elements of information required to present a product for entry into the U.S.  We will cover what information for FDA is mandatory. You must use the new software program, Automated Commercial Environment (ACE), you need to decide on who will do that, establish operational procedures, and what to do if your entry is detained. The course will explain how you can make your import operations easy, or a disaster, which ends up costing you a lot of money and frustrating your customers.

FDA and the Customs and Border Protection Service (CBP) have become increasingly sophisticated and equally demanding in the submission of import information and adherence to government procedures. Firms that fail to understand and properly execute an import and export program find their shipments delayed, detained, or refused. FDA and CBP officially implemented the Automated Commercial Environment (ACE) entry filing system. You either meet ACE requirements or face entry refusals and monetary penalties of up to $10,000 per offense. Other factors can derail the expectation of a seamless import entry process. The webinar covers detailed information required for a successful import operation and how to correct the weakest link(s) in the commercial chain. The course will include tips on how to understand the FDA's approach and the FDA's import program curiosities.

Learning Objectives:-

Importing FDA regulated products requires the submission of specific information prior to entry. Understanding what information is required and how to identify it becomes critical. Importation requires money under U.S. Customs and Border Protection’s (CBP) authority and requires compliance with FDA law, which is a partner government agency. You and your import broker must properly link the money and the law. Implementation of the Automated Commercial Environment (ACE) program is designed to make import entry easier, but you must know what you are doing, or supposed to do.

Who Should Attend?

• Domestic importers
• Foreign exporter
• Initial importers
• U.S. Agents
• International trade executives
• Import Brokers
• Regulatory affairs managers
• Import / Export consultants
• In-house counsel
• Contract specialists
• Logistics managers
• Third-party establishment inspection entities
• Sales managers