Bruce Davis is past Chair of ISPE International Board of Directors. He is a professional engineer and has many years experience in the pharmaceutical industry and a wide international knowledge. He 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. He previously worked at AstraZeneca, where he had a number of responsibilities, including managing international engineering, and this extended to provision of sterile facilities. He also facilitated the change to qualification to enable science and risk based principles to be adopted. For the past 4 years, he has run his own consultancy in QbD, Engineering, Process Validation and reducing Human Error. He has carried out extensive training, externally and in-house. He is past secretary to ASTM E55.03 Committee on General Pharmaceutical Standards. He led the setting up of a distance learning course, for a UK university, involving some 40 webinars. He is an Associate to NSF-DBA, the training & consultancy Company.