Bob Buhlmann is the Head of Quality Digital Strategy at AstraZeneca, which he has responsibility for the Digital Transformation, Data Analytics, and GMP Computer Validation and Data Integrity Programs. Mr. Buhlmann has over 32 years of industry experience with specialized interest in Software validation and digital strategies in a variety of settings, including international companies regulated by FDA and other regulatory authorities. Mr. Buhlmann work has included consulting with KMI (Parexel) as well as working in the industry with several pharma and bio pharmaceutical companies. He has participated in preparing responses and corrective actions plans for software and quality system related regulatory observations, developed and implemented global computer validation and data integrity programs, digital transformation programs for quality and has lead several global SAP and other Quality System digital implementation’s. Mr. Buhlmann has a bachelor’s degree in Information Systems and is a member of the PDA and has written articles and given presentations on Data integrity in the pharmaceutical industry.

Manuh Pitasari has more than 15 years’ experience in the areas of Pharmaceutical manufacturing operations, GxP Project Management, computerised system implementation and validation. She has been successfully managing and delivering various GxP projects across Asia Pacific and Europe, from new sterile facilities to IT solutions deployment.