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    Online Graduate Certificate in Regulatory Affairs-Medical Devices

    INSTITUTION INFORMATION Institutional Accreditation: Southern Association of Colleges and Schools Program Accreditation: Southern Association of Colleges and Schools Institutional Membership(s): SOC PROGRAM DETAILS Program Information: Graduate Certificate - Certificate-Graduate Enrollment: 999 seats total Application Deadline: Open How Students and Instructors Communicate: Chat Room, E-mail, Online Assignment Submission, Threaded Discussion Board Subject: Industrial Engineering METHOD OF COURSE INSTRUCTION

    The program is delivered primarily through compressed video

    Supplemental delivery formats include compressed video

    This course uses APEX

     
    DESCRIPTION
    The University of South Florida's Industrial & Management Systems Engineering department offers a Certificate in Regulatory Affairs (Medical Device Concentration) for individuals with technical backgrounds from the medical device / pharmaceutical / regulated industries, or other engineering environments who will occupy professional regulatory affairs positions. This program develops the requisite compliance skills by combining current regulatory approaches and quantitative techniques in a balanced curriculum, which strengthens compliance credentials and develops professional competence.
     
    SPECIAL ENROLLMENT ISSUES
    Applicants must hold an earned bachelor's degree from a regionally accredited institution.
    Candidates interested in the Certificate in Regulatory Affairs (Medical Device Concentration) must notify the department of their intent to pursue the Certificate prior to exceeding six (6) credit hours. Contact Graduate Certificates at 813-974-2442 to consult with a certificate program advisor or visit http://www.outreach.usf.edu/gradcerts/admissions.asp to download an application.
    TECHNICAL REQUIREMENTS
    Distance students must have a computer with WMP 10 and a high speed internet connection.
    ACCESS TO LEARNING RESOURCES
    APEX at USF streams classes live over the internet and then archives the files online allowing for convenient, on-demand viewing. Students must be accepted into the University to participate in the APEX distance program
    and once admitted, register through APEX as a webcast or live broadcast student in order to be eligible. A USF NetID will be required in order to access online services at the Univeristy. The NetID, available to enrolled USF students, allows students to access learning resources online, including access to the USF Library and library services for online learners. For more information please call 1-866-974-1222 or e-mail help-ac@usf.edu. The USF Bookstore may be reached by calling 1-800-873-8114. Books may be ordered online.
    ACCESS TO FINANCIAL AID RESOURCES
    Financial aid opportunities can be discussed with your program advisor. Non-degree seeking students are not eligible for financial aid. Please contact the Financial Aid Office at 813-974-4700 for exceptions and the names of private lenders. In order to be considered a full time graduate student for financial aid purposes, a student must taken 9 semester hours of graduate level work per semester.

    SPECIAL PROGRAM REQUIREMENTS

    Total program hours: 15
    EIN 6271 - Overview of Regulated Industries (Medical Device Concentration) (3)
    EIN 6272 - Regulated Quality Systems and Control (3)
    EIN 6273 -Regulated Product Approval Process (3)
    EIN 6274 - Human Factors Engineering for Medical Devices (3)
    EIN 6275 - Design Controls for Medical Devices (3)

    Additional course: EIN 6276 - International Regulations -- Medical Devices (3)
    (Available for those individuals who need 18 hours for teaching concentration.)
    SPECIAL GRADUATION REQUIREMENTS
    Time to complete the certificate is expected to be between 1 and 3 years.
    ACCESS TO ADVISING/MENTORING SERVICES
    Contact: Sally Davis, APEX Coordinator, 813-974-5852 or by email at sdavis14@eng.usf.edu
    SPECIAL TRANSFER POLICIES
    It is not anticipated that transfer courses will be accepted. Check with Sally Davis, APEX Coordinator, at
    813-974-5852.
    SPECIAL ENROLLMENT ISSUES
    A permit is required to enroll.
    Contact:
    Sally Davis
    APEX Coordinator
    813-974-5852
    SPECIAL ATTENDANCE REQUIREMENTS
    none
    SPECIAL PROGRAM PREREQUISITES
    Applicants must hold an earned bachelor's degree from a regionally accredited institution and have a 3.0 GPA or higher.
    OTHER CONSIDERATIONS
    none

     


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