Bill Schroeder

Background

About Bill Schroeder

Project Manager, Sr Validation Engineer and Quality Systems Consultant with experience in Medical Device, Pharmaceutical (OSD, solutions, suspensions and topicals) and Biotech manufacturing environments. I have experience working as a Validation Engineer, Quality Assurance representative, as well as Quality System Consultant for Consent Decree (and significant warning letter) remediation. My experience has not just been in the direct line validation, but also in the technical understanding of the Quality System development. I pride myself in maintaining the "c" in cGMP. I approach new projects as a learning experience and seek out the current industry guidance to ensure that the final product not only meets the sites procedures, but is also defendable in an audit. Having direct audit experience opened my eyes to how we should ensure that we not only meet the company SOP's, but we should also ensure that we answer the questions that may be asked by agency auditors. My experience with maintaining current standards sets me apart from many of my peers with the same years experience. I have been very lucky to have been exposed to, and learned from, some of the industry leaders in the Validation world.