MRA 603 Medical Device and PHarmaceutical Regulations

Lead Faculty: Dr. Patric M. Schiltz

Course Description

This course will focus on the laws and regulations, documentations, and process imposed by the Federal government, especially the Food and Drug Administration, related to pharmaceutical and medical device approval.  The course will provide students with detailed knowledge and practical application as it applies to appropriate documentation and process of approval for pharmaceutical and medical devices.  The students will understand the nomenclature of the regulatory agencies; have a thorough knowledge of the code of Federal Regulations as it applies to medical devices and pharmaceutical products.

Course Information

• Syllabus
• E-mail to a Friend