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  1. Courses are presented tuition free and are open on a national and international1 basis. Travel and related costs are at the expense of the attendee’s agency. A modest fee may be assessed by the sponsoring agency to cover the costs of course incidentals such as the training room, breaks and AV equipment. Meals and their cost, if offered by the sponsoring agency, are optional for attendees.
  2. The course registration contact with phone number and e-mail will be posted with each course offering in the course schedule.
  3. To register for State Training classroom courses, please make contact directly with the course registration contact at least 60 days in advance of the course. Applicants will be notified by the sponsoring agency of acceptance to the course.
  4. Courses may include some specific learning needs of the sponsoring agency. Course content, duration, and dates are jointly agreed to by the sponsoring agency, FDA regional and center staff, and DHRD’s State Training Team.
  5. The sponsoring agency administers the registration process under the following general guidelines:
    • Registration is on a first come basis with the following delineations:
    • A majority of the course enrollment (80% of the available training openings)will be reserved for the sponsoring agency.
    • The remaining portion of the enrollment (20% of the training openings) will be made available to other regulatory or investigative officials such as FDA, other federal, state, local or tribal personnel outside the sponsoring agency’s locality. Academia and industry applicants will be accepted when all regulatory requests have been filled.
  6. Courses are conducted by DHRD’s State Training Team in conjunction with the appropriate FDA Regional Office, FDA Center and Headquarters and the sponsoring state, local, tribal or federal agency.
  7. Some courses have prerequisites and it is expected that participants registering for these courses have met the pre-course requirements or equivalent.
  8. ORA U is an "Authorized Provider" of continuing education units (CEU) through the International Association for Continuing Education and Training (IACET). CEU are calculated at the rate of ten hours of instruction equaling one CEU.
  9. CEU and ORA U course certificates are provided to those course participants who:
    • Attend the entire course
    • Participate in all class activities, and
    • Successfully complete the assessment tool(s) (exercises) that measure the participant’s attainment of course objectives.

1 International participants must make their requests to Jim Fear, Manager, State Training, DHRD, e-mail or call (301) 827-8725.