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Mattie718 replied to the topic Design Review Meetings in the forum Introduction to Design Controls 6 years, 11 months ago
Working in industry, I am aware of design review meetings which happen almost weekly. One of the many engineers will have some sort of change which affects the inputs or outputs of the process or product, and this needs to be approved through design review meetings. These are very formal events which require an agenda, proposal, well prepared project lead, and attendance by managers from all applicable departments. This could include regulatory, quality, research, manufacturing engineering, and operations representatives among others. Basically anyone who may be affected needs to be in the loop and have the chance to give any feedback before the potential change is approved and implemented. It also requires several phases and various reports throughout the design change process. This is understandable since it is a step in the FDA Design Controls and that means you will need a lot of paperwork as evidence that supports your claim that the change will not introduce elevated levels of risk or failure.