Chris Wubbolt
QACV Consulting LLC, USA
Biography
Chris Wubbolt has provided quality assurance, compliance, and computer validation consulting services since 2001, specializing in establishing data integrity programs, performing data integrity audits, vendor audits, providing training, validation, and implementing six sigma based quality improvement processes. He has previously worked at Aventis Pasteur as Computer Validation Manager, working with GxP computerized 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 the guidance document on validation of laboratory systems, as well as a chapter chair for DIA “Peach” guidance on computerized systems used in clinical research. He is a Certified Six Sigma Black Belt, has a Master’s degree in Quality Assurance and Regulatory Affairs and a BS in Physics and Computer Engineering. He was the previous President of both the New England Region Chapter Society of Quality Assurance (NERCSQA) and the Mid-Atlantic Region Society of Quality Assurance (MARSQA), and is currently the chairperson of the MARSQA computer validation committee.
Abstract
Abstract : Data integrity requirements for GxPs