Lou received his B.S. degree in Biology/Chemistry from Ursinus College, his M.S. degree in Biomedical Engineering from University of Pennsylvania and an M.S. degree in Engineering and Business Management from Drexel University.
Pharmaceutical Manufacturing Program
Lou is an Associate Director (Validation) in the Quality Assurance Department at Bristol Myers Squibb Co. Lou is responsible for ensuring quality and compliance of the qualification/validation programs for GMP facilities, equipment, utilities, computer and process control systems for the Process Development Center of Excellence. Lou works in close collaboration with the Qualification/Validation Operations group, and with the Facilities/Engineering and Computer Systems organizations at BMS.
Lou started his career at Johnson and Johnson as a Research Engineer, then occupied positions of increasing responsibilities as Validation Project Manager at Fluor Daniel corporation, and Director Validation Services at John Brown Engineering. He joined Life Science International as Director Validation Worldwide then Foster Wheeler USA where he provided commissioning and validation consultation to overseas clients and managed and coordinated worldwide validation activities. Lou has held Validation leadership positions where he has assisted pharmaceutical companies with strategies on global approaches to commissioning and validation. Lou also has several articles published on the matters of commissioning and validation. He has extensive experience with the FDA as well as with EU regulations. He is an active member and frequent lecturer to various affiliations: ISPE, DIA, PDA, ASQC and IVT. Lou serves on the Board of Directors for the IVT and is an Adjunct Professor at the Stevens Institute of Technology.
PME 540 Validation and Regulatory Affairs in Pharmaceutical Manufacturing