U.S. Medical Device Quality System & Combination Products Regulations – Practical Instruction


7 hours

Course Overview

This course includes six modules. The first five modules cover the U.S. Quality Systems Regulation (21 CFR 820) and the sixth module covers the Combination Products Regulation (21 CFR Part 4). Each module includes a one-hour (approximate) video instructional presentation by former FDA official Kim Trautman, followed by a comprehensive assessment.
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