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09/05 - 12/21 | ||||||
M | T | W | Th | F | Sa | Su |
5:45 pm |
Subject: Engr Tech Leadrshp (Grad) (ETLS)
CRN: 41720
Lecture
St Paul: O'Shaughnessy Science Hall 329
Kristina Simmons, Rita Guzzetta, Liz Revnew Wolf
This class will focus on the different quality system requirements, from a regulatory viewpoint, for medical device manufacturers. The majority of the class time will be spent reviewing, froma a regulatory viewpoint, the FDA Quality Requirements and the European ISO 9000 Series requirements. There will also be some discussion regarding submissions required for approval of new products, and changes to products and/or manufacturing processes, especially in the context of changes to the quality systems that have been implemented. There will also be several classes on how to handle FDA inspections, and the ramification of non-compliance's discovered during inspections. Classroom methodology will be lectures with substantial student interaction encouraged. Students will be encouraged to share their experiences from their own companies regarding the subjects be discussed. Some portions of several of the classes will be presented by selected students, sharing what they have learned from small group interaction during class time.
3 Credits