Being that I am a fairly new engineer that entered the work industry, this course has helped me transition from a student to worker. After taking one of Dr.Simon’s courses my spring semester I knew that in order to get my tuition worth of masters program I needed to take all his courses. I learned so much about the design control process and project management material in other courses that he teaches. In this course, I began to understand EU and FDA regulations more in depth. It’s the perfect timing since I got involved in an international project at work. So Dr.Simon’s course helped me understand the path I needed to take to complete my projects at work. This course has been so relatable to the medical industry compared to many other courses I have taken thus far. The breakdown of IQ/OQ/PQ within the process validation/verification lecture pretty much covers 5 to 10 SOPs that most engineers have to be trained on.