Education and Certification

  • MSEE, University of Washington
  • BSEE, University of Washington
  • Registered Professional Engineer (P.E.), California License E10043
  • Certified Information System Auditor (CISA) 2007, non-practicing
  • Continuing education in IT systems, information security and compliance, GAMP, PDA, ISPE, ISACA, COBIT
  • Pilot, Private, Single Engine Land, Instrument

Professional Affiliations

  • IEEE, Institute of Electrical & Electronic Engineers, Senior Life Member
    • former PACE Chairman, San Francisco Section
    • former Vice Chairman, San Francisco Chapter, IEEE Computer Society
    • IEEE Computer Society
    • IEEE Engineering in Medicine and Biology Society (EMBS)
    • Championed an Internet Security Seminar with speakers from FBI, NSA, Bell Labs, SRI, Stanford
  • ISACA, Information System Audit & Control Association, Member
  • ISPE, International Society of Pharmaceutical Engineers, former member
  • PDA, Parenteral Drug Association, former member
  • ISA, International Society of Automation, former member
  • NSPE, National Society of Professional Engineers, former member

Publications

  • Contributed the Pharmaceutical Compliance chapter “Governance, Risk and Compliance Handbook” from Wiley.
  • “QA vs. IT: Who Does What When to Maintain FDA Compliance,” FOI Teleconference, April, 2011.
  • "Software/System Architecture Design as a Method to Simplify Validation," Journal of Validation Technology, May, 2000.
  • "IT Governance and Controls for FDA & SOX Compliance" Webinar, 9/2006
  • “How to assess risk for the validation of Quality System software.”
  • “Using Risk Assessments to scale the software validation tasks: Minimize the software validation costs.”

Patents

  • "Apparatus and Method for Recording Jaw Motion", Patent Number 5,340,309, Issued 1994
  • Named on two patents for water treatment process control.