This unit of study will provide students with the knowledge and skills to identify and evaluate complex technical problems and develop an implementation plan to address a problem. The unit will involve case studies from both pharmaceutical and medical device sectors, industry experts and application of international standards. Students will be given a problem from real life case studies and work through the steps to develop an implementation plan. In addition to submitting written reports, students will present their final implementation plan through recorded presentations.
online lectures, discussion forums & webinars.
Record of Invention (15%), ethics protocols and peer review (30%), recorded presentation and peer review (20%), case study (15%), 510(k)/CA summary and peer review (20%)
Online readings and other learning resources will be provided
PCOL5101 or PCOL5102