Mr. Wubbolt has provided quality assurance and computer validation consulting services since 2001, specializing in validation of computerized systems, as well as quality assurance activities such as auditing, training and quality improvement processes. Prior to becoming a consultant, Mr. Wubbolt worked at Aventis Pasteur as Computer Validation Manager, working with CDMS, EDMS, pharmacovigilance, ERP, MES, manufacturing control and laboratory systems. Prior to joining Aventis Pasteur, he worked at Johnson & Johnson’s McNeil Consumer Products Company in the National Quality Assurance Group and at Lancaster Laboratories. He was a contributing member of the GAMP Laboratory Systems Special Interest Group, which published a guidance document on validation of laboratory systems, as well as a chapter chair for the DIA committee developing guidance on computerized systems used in clinical research. Mr. Wubbolt is a Certified Six Sigma Black Belt, has a Masters Degree in Quality Assurance and Regulatory Affairs and a BS in Physics and Computer Engineering.