Mark Hannon is a Principal Technical Manager in Genentech’s GMP Systems Compliance organization. Since moving to the quality organization three years ago, he consults on compliance issues and performs GMP internal and CMO audits. Hannon has conducted eight audits at four new facilities that utilize Risk Based approaches to qualification as well a leading an evaluation of risk based validation practices at three established sites. These audits include API, bulk biologics, filling, packaging, and drug product distribution functions at sites in Asia, Europe and North America. Previous to joining the Quality organization, Hannon spent twelve years in Genentech’s Engineering group in a variety of positions, including Senior Manager Process Engineering. He served as an engineering lead on projects in the areas of aseptic filling, bulk biologics, and critical utilities. Hannon is a past president of the award winning ISPE San Francisco Bay Area Chapter and a member of the ISPE North American Education Committee (NAEC).