FDA’s and U.S. Custom’s Import Entry Program

Presented by Casper Uldriks

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.

Mastering the Export Administration Regulations

Presented by Jo-Anne Daniels

Participants will learn the basics of the Export Administration Regulations, the mechanics of export classification and apply the rules to their products. They will understand that there is more to exporting than just shipping a freight container across a border into another country. The webinar will explain what an export is and what procedures must be implemented and followed in order for their company to comply with the Export Administration Regulations. The participants should be able to return to their office and enhance their export compliance program or develop and roll out a new one. The webinar will help the participants feel more confident with exporting and how to communicate the importance of complying with the EAR.

How to Use Foreign Trade Zones and Bonded Warehouses in the U.S.

Presented by Casper Uldriks

The use of Foreign Trade Zones and Bonded warehouses for FDA regulated products create different opportunities and different obligations. Firms need to understand the requirements of each to use them to their advantage. The imported products will have different regulatory requirements depending on the option chosen. In some cases, the FDA does not give you an option and the outcome is expensive. Firms also must consider the physical security and controls of their products. Theft, loss, damage, or diversion must be factored into your decisions. Your choices need to consider the risks posed by using one approach versus another. Your cargo shipment may be very valuable and should be treated as such.

Jo-Anne Daniels is the President of Trade Resources & Associates, a firm of experts in cross-border transactions, global trade, and logistics matters. Ms. Daniels is an experienced seminar and webinar speaker, corporate trainer, and published authority in trade compliance and logistics, her career spans over 25 years in international trade, logistics, and transportation employed with multinational corporations, transportation carriers, freight forwarders, and airlines. She has held senior management roles at multinational companies building and maintaining solid export and import compliance programs, driving the hiring and managing of carriers, customs brokers and freight forwarders.

Casper Uldriks, through his firm “Encore Insight LLC,” brings over 32 years of experience from the FDA. He specialized in the FDA’s food and medical device programs as a field investigator, served as a senior manager in the Office of Compliance, and as an Associate Center Director for regulatory guidance and government operations. He developed enforcement actions and participated in the implementation of new statutory requirements, such as FDA’s import/export program. He is recognized as an exceptional and energetic speaker. His comments are candid, straightforward, and practical value. He understands how the FDA thinks, operates, and where it is headed. Cap is the President of Encore Insight, LLC, a consulting service for FDA matters.