Ken Rothfeld is Director of CSQA for Johnson & Johnson Pharmaceutical Research and Development, L.L.C., where he oversees all computer validation activities. Previously he was President and CEO of Business Management Solutions, Inc., working with global pharmaceutical and biological companies in Quality System Optimization, document management, compliance, validation, web-based applications, strategy, process, and reducing time to market. With 20+ years of information technology experience and more than a decade with RA and Compliance, he has managed database administration in drug safety, surveillance, labeling, and regulatory submissions groups. Consulting in several areas of R&D, he established the computer validation initiative for GLP, GCP, and GMP compliance for a Johnson & Johnson company and Covance. Recognized globally for expertise in computer system compliance, process and strategy, he is co-founder of a worldwide corporate validation chat group and a past member of the Computer Validation Committee at PhRMA. Listed in Who’s Who, he has lectured globally, chairing several computer validation conferences.

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