A review of the Inspection Observation Summary for FY2013 was conducted with a focus on inspections of Devices. From 10-1-12 to 9-30-13 approximately 1099 device 483’s were issued and a total of 4393 citations were referenced. This is approximately the same number of 483’s that were issued in 2012 (N=1090), however the number of citations referenced in […]
Med Devices Services Manager -
Alex has over eight years of experience in medical devices and manages the validation and PPAP teams. He has vast experience with developing and executing equipment qualification, test method validation, and process validation documents to ensure they meet the quality system and regulatory requirements. He has led multiple large validation projects that have ranged from new manufacturing lines to transferring product lines from one site to another.
