Skip page top navigationFDA Logo--links to FDA home page Logo of and Link to start page of Office of Regulatory Affairs, U.S. Food and Drug Administration U.S. Food and Drug Administration Office of Regulatory Affairs HHS Logo and link to Department of Health and Human Services website

FDA Home Page | Federal-State | Import Program | Compliance | Inspection | Science | ORA Search

 

Site Facilitator Instructions/Checklist

General: As a site facilitator, your involvement is critical to the success of this course. The following is a list of responsibilities you should accomplish at your site:

  1. Identify a suitable training location. First, make sure that the site you select has a steerable dish capable of receiving C-band satellite signals. Make sure the room contains adequate seating arrangements and has access to a phone and FAX machine (preferably outside of the room to reduce any electronic feedback if phone/fax are used during the live program). Make sure that all participants will be able to view the course.
  2. Register students. Make sure all students fill out the registration form. This is especially important if you wish to receive course certificates from FDA. A downloadable copy of this form is found on our web page. Also make sure all students sign in before the course begins on both days. A downloadable sign-in sheet is found on our web page. The web site is:
  3. http://www.fda.gov/ora/training/course_ora.html

  4. Download and print student materials. Our web site contains student materials. Please download these materials and make adequate copies for all the students. Additional materials that should be available for student use: flipchart paper, markers, pens
  5. Monitor all site activities. Throughout the course, the audience will be asked to participate in a variety of activities and apply some of the concepts they were taught. Your responsibility is to divide the audience into groups of 4-6, and, using the instructions proved by the course moderator and from the material found in the student guides, ensure that all students complete these exercises. If you have any groups that would like to share their input as part of the live broadcast, feel free to have them phone in their answers by calling 1-800-527-1401. Please review the student guides for site activities before the broadcast to become familiar with the exercises. The exercises are typically found at the end of each topic in the student guides. Pre-Selected Call-in Sites: Although we expect many phone in responses to the site activities, some sites will be pre-selected. To sign up as a pre-selected site, send an e-mail to ORADLT@ora.fda.gov and indicate your name, location, phone number, site activity, and the phone number where we can reach you during the day of the broadcast. Off-Air Exercise: At the end of the first day, one site activity will be completed off the air and will require your assistance. Depending on your time zone, you may be able to run the site activity before the beginning of Day 2, or (if you are located in the West Coast) you may want to conduct the exercise at the end of Day 1. Refer to student guide and the moderator for instructions on the first day of the course. We will start off the course on Day 2 with phone-in responses to the site activity and panel experts will provide feedback.
  6. Course Certificates and Feedback to FDA Division of Human Resources: In order for students to receive a certificate indicating CEU/Contact Hours, at the conclusion of the course, FAX the following documents to the FDA Division of Human Resources Attn: Satellite Courses at: (301) 594-3867. Use of this FAX line direct into our database should expedite processing. (Note: if this line is busy please wait a few minutes; if you still cannot get through, FAX to (301) 594-1966):

               a. Registration forms.
                    b. Course evaluation forms.
               c. Site facilitator verification form (see the last page of these instructions for this form).

               d. Address for mailing course certificates. Please include your mailing  address. 

Due to the volume of students, we will not be able to mail certificates to individual students.

Due to the large number of anticipated students, please allow 3-4 weeks for certificates to be processed.

Questions? Call the ORA Distance Learning hotline at (301) 594-2263 or e-mail at ORADLT@ora.fda.gov and someone will respond to your question.

THANK YOU!

 

Subject: Student Verification, Communication Skills for Regulators, CM 1001

Instructions: Please fill out the following information. Fax this sheet along with all student registration forms and course evaluation forms to (301) 594-1966, Attention: Communications Satellite Course.

Name of State Contact: ____________________________________________

Address of State Contact: __________________________________________


________________________________________________________________

Phone/Fax numbers for of State Contact:

________________________________________________________________

Location of Training Site: ___________________________________________

Statement:

"I verify that the attached names are registered students who have successfully competed the course through full course attendance and active participation in all class exercises."

 

_____________________________________

Signature/date

 

 

The FDA Division of Human Resource Development will be issuing certificates to registered participants within 30 days of receiving this form. Fax this form along with all student registration forms and course evaluation forms to (301) 594-1966, Attention: Communications Satellite Course. Please contact (301) 594-2263 if you have any questions. Thank you.