Mike Byrd, the Director of Computer System Validation (CSV) for ProPharma Group has over 25 years in the pharmaceutical and biotechnology industries, and over 30 years of information systems experience. Mike’s educational credentials include a Bachelor of Science in Chemistry and a Master’s in Business Administration with an emphasis in Technology Management. Mike has developed, implemented, administered, and validated a wide variety of computer-based solutions supporting critical regulated business processes. These included systems supporting automation and control on the shop floor; laboratory automation, data acquisition, and information management; quality workflow management; manufacturing execution; distribution; shipping; enterprise resource planning, interfaces for cross system integration and IT infrastructure supporting a diverse technical computing environment. He has held numerous individual contributor and management roles in his career, many of which have involved forming and managing cross-functional system project teams. Professionally, his interest is in the application of IT best practice to support compliance requirements, software quality assurance approaches and trends, and the application of new technologies in advancing efficient and effective controls for managing system quality and risk. Mike is a Certified Quality Auditor and senior member of the American Society for Quality. Through participation in industry forums, Mike continues to exchange ideas with other CSV professionals in promoting computer systems compliance and quality.