Brian Shoemaker PhD

Brian Shoemaker consults for healthcareproducts companies in computer system validation, software quality assurance,and electronic records and signatures. Hehas conducted validation both on product software and on internal software, developedsoftware quality systems, audited software quality processes (including agilemethodology), and evaluated 21 CFR Part 11 compliance. He has had clients in clinical diagnostics,medical device engineering, medical imaging, medical-device fabricsmanufacturing, contract lyophilization, clinical trial software, dentalprosthetics, and bone-repair implants. Hehas worked with companies in Germany and Switzerland as well as the U.S.

Previous to founding ShoeBar Associates,Brian had quality roles at PPD Informatics, Doxis, Inc., and Behring Diagnostics, Inc. Brian earned his Ph.D.in chemistry from the University of Illinois; he has achieved the ASQ Software Quality Engineer certification.