Michael Crowthers

Mr. Crowthers is a Life Sciences professional with extensive experience in IT process compliance and computer systems validation (CSV) and verification activities in various sectors of business in the Life Sciences industry. His thought leadership around cost-effective and process efficient IT compliance has served organizations varying in size and complexity to apply a practical and maintainable approach to systems implementation as well as compliance and validation. Mr. Crowthers has been an active speaker and trainer at various Life Sciences conferences, including the Institute of Validation Technology (IVT). His conference participation spans over the past 10 years with participation at several IVT CSV conferences held in Arlington, VA as well as Philadelphia, PA. His conference forums have focused on the areas most crucial to successful validation including Risk Management and Configuration/Change Management. Mr. Crowthers is also an active member of the International Society for Pharmaceutical Engineering (ISPE) and is well versed in the principles of GAMP5®. Some highlights from Mr. Crowthers' career include working as the IT Compliance and Validation Lead for several global companies within various sectors of the Life Sciences industry (Pharmaceutical, Med Device, Biomedical) implementing enterprise application solutions (ERP, PLM, etc). Mr. Crowthers was also the Solution Architect for QPharma’s Compliance Advantage™ Solution, which provides companies with quicker project ROI through the integration of accelerated validation tool sets, and IT compliance key performance benchmarking and metrics. Some of the strategic solutions include the assistance with establishing the initial design of Oracle’s Electronic Record and Electronic Signature (ERES) functionality that is now native to the Oracle E-Business Suite. Another example of the thought leadership Mr. Crowthers has provided was the establishment of a paperless donor registration design for a national blood banking institution, saving approximately $1M in annual costs to the organization and improving overall record accuracy.