Experience
FDA GLP experience since 1989 with drugs and medical devices
Positions held as Quality Assurance Manager responsible to design, implement and oversee GLP quality systems
Designed and implemented contract GLP archive
Team member/advisor for manufacture of GLP test material
Project manager for 21 CFR PArt 11 project
Positions held as Quality Assurance Manager responsible to design, implement and oversee GLP quality systems
Designed and implemented contract GLP archive
Team member/advisor for manufacture of GLP test material
Project manager for 21 CFR PArt 11 project
Credentials and Education
Registered Quality Assurance Professional - RQAP-GLP
Medical Technologist - ASCP, CAMT
MS Clinical Chemistry and Laboratory Management
BS Chemistry and Medical Technology
Memberships
SQA
ASQ
PRCSQA
Active member of SQA specialty sections
CV upon request.
Medical Technologist - ASCP, CAMT
MS Clinical Chemistry and Laboratory Management
BS Chemistry and Medical Technology
Memberships
SQA
ASQ
PRCSQA
Active member of SQA specialty sections
CV upon request.