Synergy is more than a buzzword to me. It’s a promise I make to my team. As a Managing Partner of Azzur Group, my focus is supporting my employees' and customers' unique abilities in a way that reinforces strength, backs up weakness, and achieves maximum efficiency. My technical expertise follows a proven process of Discovery To Delivery™. Using it, I concentrate on identifying and implementing solutions for compliant computer-based manufacturing, research and laboratory systems to ensure FDA GxP regulatory compliance.I firmly believe in leading by example and coaching younger industry professionals. Toward that goal, I am a frequent presenter at various industrial, professional, and trade associations on the subject of risk based systems validation, eRecords/eSignatures compliance, and data integrity. I have also been engaged as an ISPE Instructor for GAMP5. My nearly 40 years of FDA regulated industry experience includes management positions at Wyeth and J&J/McNeil Pharmaceutical and spans projects conducted within QA, IT/IM, Manufacturing / Operations, Clinical and R&D. I am a former member of the PhRMA Computer Systems Validation Committee, a former chair of the ISPE DVC CSV Sub-Committee, a former Core Team member for the PDA Part 11 Task Group, and past Chair of GAMP Americas Steering Committee, past Co-Chair of GAMP Global, and former Sponsor to the GAMP Risk Management Special Interest Group. I have a Bachelor Degree in Chemistry from Delaware Valley College of Science and Agriculture and a Master of Engineering in Manufacturing Systems from Penn State University. Specialties: ISPEGAMP Americas (Past Chair - Steering Committee)GAMP Global/Council (Past Co-Chair)Global Emerging RegulationsRisk ManagementSupplier Auditing (Quality & Computer Systems)Risk Assessments (GAMP, ICH Q9)