Michael Osburn

I have over 25 years of IT and quality experience supporting all aspects of the software development life-cycle. I am widely recognized resource to assist business, IT and quality management in assessing computer systems validation (CSV) status and providing CSV expertise. I have driven major process improvement projects to enhance internal IT best practices and standards that have helped advance the overall maturity of the SDLC components and processes. I am a member of the GAMP Americas Steering Committee within the Good Automated Manufacturing Practice (GAMP) within International Society for Pharmaceutical Engineering (ISPE), and a contributing member to the GAMP Infrastructure Special Interest Group (SIG). I am also the founder of an External Benchmarking Forum that is an informal association of representatives from life sciences in the pharmaceutical sector that meets routinely to discuss current perspectives and topics related to computer systems validation (CSV), IT/Automation best practice, computer system inspections trends, and current computer system initiatives in the pharmaceutical industry.