Information Systems professional with 25+ years of experience, specializing in compliance, security, and risk management for heavily regulated industries - life sciences, health care, payment card industry, banking, and service organizations catering to these industries.360 view on IS compliance from the perspective of the regulated organization, also in the role of consultant, as well as provider of SaaS/PaaS/IaaS and security and compliance services.* Common sense and a well-documented risk-based approach are your friend. *Specialties: PCI DSS, FDA and EU GxP Regulations (Part 11, EU Annex 11), GAMP, HIPAA/HITECH, SOC, and compliance in the cloud.
Listed skills include Cloud Computing, Cloud Security, 21 Cfr Part 11, Hipaa, and 26 others.