Penny Goss Technical Solutions
ph: 702.617.9118
penny
Penny Goss
Over twelve years experience writing user and functional requirements specifications, design specifications, test plans, IQ and OQ protocols. Has written complete software validation for 510K submittal, MRP systems, as well as participated in development of evaluation and remediation plans to meet FDA CFR 21 Part 11 requirements and Sarbanes Oxley regulation. Has written SOP’s and DOP’s for quality assurance and regulatory compliance at both the corporate and divisional level. Understands GAMP Standards, ISO 9000 standards, GxP regulations, FDA guidelines and regulations as they apply to software validation. Is familiar with COSO and COBIT framework used to develop controls and tests for Sarbanes Oxley adaptation.
"I think it says a lot that many of my clients have not only continued to use me as their documentation resource for multiple projects, but have also referred me to anyone they felt needed my help."
Client List
Affymetrix
Cardiovascular Systems Inc.
Cisco Systems
Cohesion
Conceptus
Cordis (a Johnson & Johnson Company)
CryoVascular Systems Inc.
Cytyc - Surgical Products Division
Ditech Communications
Eli Lilly / Isis Pharmaceuticals
FoxHollow Technologies
Genentech (South San Francisco)
Genentech (NIMO Division)
Guidant (ES Division)
Health Hero Network
Nitinol Devices & Components (a Johnson & Johnson Company)
Thermage
Nitinol Devices & Components (a Johnson & Johnson Company)
Thermage
Nitinol Devices & Components (a Johnson & Johnson Company)
Thermage
Nitinol Devices & Components (a Johnson & Johnson Company)
Thermage
Nitinol Devices & Components (a Johnson & Johnson Company)
Thermage
Watson Laboratories Corp.
Watson Laboratories (Salt Lake City)
FDA, Sarbanes Oxley, ISO Procedures, HIPPA
ph: 702.617.9118
penny
