ATOM Partner to Keynote 2016 PLM User Conference San Francisco


Jason J. Sgro

The Cost of Doing FDA Part 11 Poorly; Lessons Learned in Becoming a Truly Paperless Company

Jason’s presentation will focus on trying to move a medical device manufacturer to full part 11 compliance with examples of quick failures and resolutions. He will discuss software development, manufacturing issues and FDA handling using true stories and readiness exercises primarily focused on controlled systems and automating output for development, manufacturing and clinical.