James G Robertson, P.E. - Credentials, Affiliations, Publications & Patents
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
- 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
- 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.”
- "Apparatus and Method for Recording Jaw Motion", Patent Number 5,340,309, Issued 1994
- Named on two patents for water treatment process control.