Export Due Diligence: What Every U.S. Exporter Must Know?
José Mora is a Principal Consultant specializing in Manufacturing Engineering and Quality Systems. For over 30 years he has worked in the medical device and life sciences industry specializing in manufacturing, process development, tooling, and quality systems. Prior to working full time as a consulting partner for Atzari Consulting, José served as Director of Manufacturing Engineering at Boston Scientific and as Quality Systems Manager at Stryker Orthopedics, where he introduced process performance, problem-solving, and quality system methodologies. During that time he prepared a white paper on the application of lean manufacturing methods to the creation and management of controlled documents and a template for strategic deployment. José led the launch of manufacturing at a start-up urology products company as Director of Manufacturing for UroSurge, Inc. at the University of Iowa’s business incubator park in Coralville, IA, creating a world-class medical device manufacturing operation, with JIT, kanban systems, visual workplace, and lean manufacturing practices.
José worked for 10 years at Cordis Corporation, now a Cardinal Health company, where he led the successful tooling, process development and qualification of Cordis’ first PTA (percutaneous transluminal angioplasty) catheter. His medical device experience includes surgical instruments, PTA & PTCA dilatation and guiding catheters, plastic surgery implants and tissue expanders, urology implants and devices for the treatment of incontinence, delivery systems for brachytherapy, orthopedic implants and instruments, and vascular surgery grafts and textiles. During his time at Cordis, José managed the Maintenance and Facilities Department, taking that operation to a level rated as “tops” by the UK Department of Health and Social Services (DHSS) during one of their intensive audits. Jose managed Manufacturing Engineering as part of the Guiding Catheter Core Team of managers, a team that took the Cordis Guiding Catheter business to lead the market, bringing it up from fourth place. By introducing world-class techniques, the Guiding Catheter design and manufacturing was completely re-engineered for robust design and tooling, under Jose’s leadership. He was also instrumental and played a leadership role in the complete re-engineering of the Tooling Control System, including design drafting, the tool shop, and technical support. Wherever he has worked, he has a track record of introducing world-class methodologies such as Kepner-Tregoe, Taguchi techniques, Theory of Constraints, Lean Manufacturing, Five S (Visual Workplace), process validation to Global Harmonization Task Force standards, and similar approaches.
Provisions in the Export Administration Regulations (EAR) require that exporters know their exports, destinations, end-users, and end uses. Exporters must submit an individual validated license application if the exporter "knows" that an export that is otherwise exempt from the validated licensing requirements is for end-uses involving nuclear, chemical, and biological weapons or related missile delivery systems, in named destinations listed in the EAR. And for those exporters whose products or services are subject to the International Traffic in Arms Regulations (ITAR), there is a great need to conduct meaningful due diligence, For munitions export control violations, the statute authorizes a maximum criminal penalty of $1 million per violation and, for an individual person, up to 10 years imprisonment in addition, munitions violations can result in the imposition of a maximum civil fine of $500,000 per violation of the ITAR, as well as debarment from exporting defense articles or services. For dual-use export control violations, criminal penalties can reach a maximum of $500,000 per violation and, for an individual person, up to 10 years imprisonment. Dual-use violations can also be subject to civil fines of up to $12,000 per violation, as well as denial of export privileges. It should be noted that in many enforcement cases, both criminal and civil penalties are imposed.
By attending the presentation, you will learn how to conduct meaningful due diligence to avoid becoming an export violator.
Areas Covered
- General provisions
- Enforcing agencies
- Criminal, civil, and administrative penalties
- How to conduct due diligence?
- “Red Flags”
- Free resources of information and assistance
Who Should Attend
CEOs, CFOs, Human Resource directors, import company directors and managers, export company directors and managers, and business owners.
Why Should You Attend
- There has been a substantial increase in the number of new cases involving export violations
- There has been a substantial increase in the number of fines and penalties for violators of export laws and regulations
- There is an increased focus on prosecuting exporters
- Parent companies can be held liable even if they have no knowledge of the actions of their subsidiaries
- Companies can be held liable for actions of third parties acting on their behalf (e.g., freight forwarders, distributors, resellers, agents, etc.)
- Find out how not to run afoul of the export control system, enhance profitability, and safeguard your reputation
Topic Background
U.S. exporters must use due diligence with respect to their export transactions, The United States Government restricts exports of certain sensitive equipment, software, and technology to promote national security interests and foreign policy objectives.
Through the export control system, the U.S. government can effectively:
- Provide for national security by limiting access to the most sensitive US technology and weapons
- Promote regional stability
- Take into account human rights considerations
- Prevent proliferation of weapons and technologies, including weapons of mass destruction, to problem end-users and supporters of international terrorism
- Comply with international commitments
U.S. exporters must know how to determine if their goods require export licenses, Quite often, exporters run afoul of the U.S. export control system because they fail to realize that because of the nature of their exports, the places to which they are sending their exports, or the person to whom they are sending their items, they are going to be in violation of the law and subject to heavy fines and penalties.
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$200.00
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