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MRA 606 FDA Regulations and Submissions

Lead Faculty: Dr. Patric M. Schiltz

Course Description

This course will give the student the fundamental knowlegde of FDA regulations as they apply to medical devices and pharmaceutical products and the documentation needed for such approval.  The code of Federal Regulations will be utilized with emphasis on CFR 21, FDA compliance, ICH guidelines for international harmonization and Good Clinical Practice (GCP), investigator study files, FDA audits, and Adverse Event reporting.

Course Information

Breadcrumb Trail

  1. Home
  2. Our Programs
  3. School of Health and Human Services
  4. Health Sciences
  5. Courses
  6. MRA 606

National University is an affiliate of the National University System.