Join Ken for his presentation, "How Computer Software Assurance is Like Raising a Strong Daughter"!
DATE: TBD
Computer Software Assurance (CSA) is the modernization of validation and it is a potential game changer for industry. In this session, we will demystify CSA and explain how a successful CSA transition is a lot like raising a strong daughter
Ken is the head of IT Quality Engineering at Gilead and over 25 years of experience in the BioPharamaceutical Industry. He is a member of the FDA-Industry Computer Software Assurance team. As a member of ISPE, Ken is a co-lead for the CSA SIG, and has worked on the CSA Appendix in the GAMP GPG Data Integrity by Design, Critical Thinking chapter of the GAMP GPG Enabling Innovation, and GAMP 5 v2. He holds a BA in Molecular Cell Biology from UC Berkeley, and a MS in Computer Science from San Jose State University. He is a CISSP, CISA, CIPT, CTFL, CPRE, and PMP.