A constant source of frustration for drug manufacturers shipping products to the United States is mandates from FDA and U.S Customs and Border Protection (CBP) for import of medicinal products. These requirements affect not only finished product, but also everything from active ingredients to devices used in support of clinical trials.
This course addresses the 2016 implementation of FDA’s and CBP’s new entry information program — the Automated Commercial Environment (ACE) — which applies to the initial importer, the customs broker, and the foreign firm associated with an imported product’s entry into the U.S. Importers and brokers currently struggle to use the correct FDA information codes, and failure to do so may cause the entry to be detained and monetary fines. The ACE procedures, entry status information, and simplification of entry documentation can provide significant benefits to the parties involved, but the importer and broker must understand the operational function of the ACE program to use it successfully.
Join our interactive online training course, where you will learn:
This course will be of benefit to initial importers of FDA-regulated products who find use of the new ACE software system problematic. The entry process includes a U.S. initial importer, broker, and a foreign establishment, all of whom must provide correct information and coding under the ACE program in order to avoid a delay, detention, or refusal of an entry. A firm’s regulatory affairs, quality assurance, and logistics managers must understand the ACE requirements and sequence of the operations so they can use the ACE program correctly and enjoy the benefits.
Casper (Cap) Uldriks brings over 32 years of experience from the FDA. As a field investigator, he conducted import operations in the New England (Boston) District Office, which provides broad-based practical knowledge of FDA’s import program and procedures. As a senior manager in the Office of Compliance and as an associate center director for the Center of Devices and Radiological Health (CDRH), he served as the center’s expert on import and export operations and policy.
He managed the implementation of the FDA Export Reform and Enhancement Act of 1996 and development of intra-agency policy for imports, exports, and entry criteria for the FDA’s risk-based software screening program, known as PREDIDT. He routinely trained FDA staff and was featured as a public speaker on the statutory import and export requirements and how they operated for enforcement purposes.
He is recognized as an engaging and energetic speaker. His comments are candid, straightforward, and of practical value. He understands how FDA thinks and operates, and where it is headed.