Well versed in industry and FDA activities, strategies and compliance concerns regarding computer and automated systems. He has a sound working knowledge of current Good Manufacturing, Laboratory and Clinical Practice (GMP/GLP/GCP) regulations including 21 CFR Parts 820 and 11, and have published and presented numerous papers on the subjects of validation, risk-based quality systems, and quality assurance. Inducted into the Institute of Validation Technology’s Validation Hall of Fame in October 2003.Specialties: I have more than 30+ years experience in QA/QC, regulatory compliance, and the assessment and validation of pharmaceutical and biopharmaceutical facilities and processes, specialty water systems, analytical methods, laboratory equipment, and computer systems.