US Naval Academy Engineer that started a CSV Professional Services company in 2008 that provides validation/qualification services to Pharma/Bio clients that include: Merck, Mylan, Teva, CSL Seqirus, Organon, Novo Nordisk, GSK, Pfizer, Resilience, etc.. Core strength in creating company specific global CSV frameworks (Policies/Procedures/Work Instructions/Templates) that allow for compliant and consistent FDA computer system validation activities. Core focus on separating IT infrastructure and leveraging Computer System Assurance (CSA) principles to create streamlined qualification programs for IT infrastructure that compliment the CSV framework. Proficient in U.S. Food and Drug Administration (FDA) regulations. Skilled in AWS IaaS/PaaS qualifications, Cloud SaaS Validations, Infrastructure Security, IT/OT separation and validations, Socializing validation programs throughout a company.

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Network Consulting Group