Bruce Davis, Principal, Global Consulting is a professional engineer, and has many years’ experience in the pharmaceutical industry and a wide international knowledge, and operates a consultancy in QbD, Engineering, Process Validation and reducing Human Error. He is an Associate to NSF-DBA, the training & consultancy Company. He previously worked at AstraZeneca, where he had a number of responsibilities, including managing international engineering, and this extended to provision of sterile facilities. Davis has been a member of ISPE since 1991, and is a member of the United Kingdom Affiliate. He has held the position of Chair of ISPE International Board of Directors and has been active in supporting ISPE, including leading the team writing the original Sterile Baseline® Guide and its current update. He also led ISPE’s case study for practical implementation of Quality by Design (QbD) and is currently co-chairing the team updating ISPE’s Technology Transfer Guide. Davis also facilitated the change to qualification to enable science and risk based principles to be adopted. Previous experience includes the position of past secretary to ASTM E55.03 Committee on General Pharmaceutical Standards and leading the team that set up a distance-learning course, for a UK university, involving some 40 webinars.