Susan Schebler has been a QA Consultant in the Global Quality Systems group at Eli Lilly and Company since 2006. She is currently owner of the Lilly Deviation Management, Change Management, and Documentation standards. She also provides QA business support for several GMP computer applications, including Deviation, CAPA and Change Management processes. In her 33 years at Lilly, she has held various assignments in API Process Development, Technical Service, and Quality Assurance. Susan is a member of the core team which wrote the ISPE PQLI Guide on Change Management. She holds a B.S. in Chemical Engineering from Iowa State University and an MBA in Production Operations from the IU Kelley School of Business in Indianapolis.