Robin Fralick

Principal Consultant, Software Validation

Robin Fralick is a software quality professional with more than 35 years of experience in the pharma/medical device industry. Robin started her career as a research biochemist at Hoechst- Roussel (now Aventis) and then transitioned into information management and regulatory compliance. She has served in key compliance roles involving software validation for cardiac telemetry systems, clinical hematology analyzers, digital imaging equipment and home HIV test kits. She has helped numerous organizations identify and resolve critical software issues with high business impact. Robin has also developed successful risk management programs for medical devices and combination products. She has experience interacting with the FDA in pre-market approval inspections and has been involved with multiple QSR remediation efforts. Her writing skills are frequently tapped during the creation and close-out of complex CAPAs and written responses to FDA 483 inspectional observations.

 

Robin has a BS in Chemistry and became a Certified Software Quality Engineer (CSQE) in 1998.