Export Management & Compliance

How to Develop an Export Management & Compliance Program, Including the I–129 for Deemed Exports is a six-hour professional development course for individuals who manage the shipping and exporting program, including deemed exports, at universities and biotech companies.

Speaker Presentations

Deborah Howard, University of North Carolina at Chapel Hill

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Overview

How are you handling certification regarding the release of controlled technology or technical data to foreign persons in the United States? Learn about the fundamental research exclusion and the impact deemed exports have on your organization. Do you have foreign nationals in the workplace? Ship biological materials (or genetic elements) out of the U.S.? Export select agents? Ship items that cost more than $2,500 out of the U.S.? Is your software controlled? Do you have controlled “development” technical research?

Learn to understand the six terms of use as they relate to foreign nationals in the workplace. There is more to shipping than classification, labeling and marking. When shipping anywhere outside the U.S., including Puerto Rico, there also are licensing, under-invoicing and ITN numbers from the U.S. Census Bureau to consider. During this workshop you will learn about the SNAP-R program, visual compliance and how the International Traffic and Arms (ITAR) Regulations fit into exporting. Troublesome clauses in contracts also will be covered. The course will discuss which pathogens and lab equipment require a license when exporting, how to obtain a license, Census Bureau requirements, recordkeeping and much more.

Agenda

Welcome

Overview & Key Export Agencies
Deborah Howard
President and Treasurer, CaBSA
Biological Safety Officer, Alternate Responsible Official, UNC Chapel Hill

Key Issues for Universities and Biotech Companies
Deborah Howard

Lunch

Government Resources to Help You ExportShirreef Loza
Senior International Trade Specialist, International Trade Administration, U.S. & Foreign Commercial Service, U.S. Department of Commerce

It’s a SNAP-R to Obtain a License
Deborah Howard

Licensing the Technology
Deborah Howard

Exemptions
Deborah Howard

Break

Exercises
Deborah Howard

Building an Export Control Program Using UNC Chapel Hill as an Example
Deborah Howard

Visual Compliance Program
Deborah Howard

Adjourn

Course Leader

Deborah Howard, CBSP, University of North Carolina at Chapel Hill

Deborah Howard is the Biological Safety Officer (BSO) and Alternate Responsible Official at the University of North Carolina at Chapel Hill. She has been the BSO at UNC since 2008. Deborah has extensive experience with Select Agent regulations and has experience in writing biosafety plans, personnel suitability assessment programs, incident response plans, security plans, drills, SOPS and trainings. She has over 20 years of experience in health and safety issues including NIH, OSHA, EPA, biosafety, hazardous materials shipping and exporting. She is the Institutional Biosafety Committee (IBC) Administrator at UNC overseeing compliance for recombinant and synthetic genomic material on campus.

Deborah also reviews applications for human gene transfer protocols to ensure compliance with the Institutional Review Board and National Institutes of Health. She oversees eight high containment labs including four labs with agents strictly regulated by the Centers for Disease Control and Prevention. She also is responsible for compliance for the 11 HIV labs on campus. She is a graduate of the University of North Carolina at Wilmington, where she earned her B.A. She has an MPH from UNC Chapel Hill in addition to being a Certified Biological Safety Professional (CBSP).

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Event Details
  • Friday, May 20, 2016

    9:30 am – 4:00 pm

  • North Carolina Association for Biomedical Research

    3901 Barrett Drive, Suite 300

    Raleigh, NC 27609

     

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