National University




MRA 606 FDA Regulations & Submissions

Lead Faculty: Mr. Irvin Kluth

Course Description

This course will give the student the fundamental knowledge 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.

Learning Outcomes

  • Evaluate proposed products for appropriate FDA regulatory jurisdiction.
  • Understand the Code of Federal Regulation as it applied to pharmaceutical and medical devices.
  • Understand the regulatory pathway that will be necessary to follow for product approval.
  • Develop effective regulatory submission strategies for timely FDA product review.
  • Develop a master file for meeting FDA regulations.
  • Understand and evaluate good clinical practice (GCP).
  • Ensure clinical trial design, conduct and documentation are in compliance with GCP.
  • Be able to identify and understand adverse events with appropriate reporting.
  • Be able to write appropriate documents for FDA approval of a new drug or medical device.
  • Develop a standard operating procedures (SOP).
  • Develop and implement compliance documentation.
  • Understand labeling of a product or device.