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I currently work for a medical device cell culture company that adheres to 21-CFR-820, 21-CFR-210, 21-CFR-211; ISO9001 and ISO13485. Within our training program, we train manufacturing personnel using a combination of OJT and computer-based learning. We have personnel demonstrate and record that they are competent on the processes prior to allowing them to perform the work by themselves, along with re-demonstrating and record the continued competency in the process every 2 years. It has recently come into question if we need to continue require the personnel to re demonstrate competency every 2 years from a regulatory stand point. Does anyone have any insight where i might be able to locate evidance whether or not if we need to continue to re-demonstrate competency on the processes past the initial demonstration?