Debra Fontana, RPh

GxP Compliance Consultant

Debra Fontana, RPh, is a collaborative Quality Assurance, Clinical Compliance, and Computer System Validation expert with over 33 years of experience in the pharmaceutical, biotechnology, and software development industries. Deb started her career working on the GMP side of the pharmaceutical industry, then transitioned to computer system validation, Quality Control, and Quality Assurance. She then worked for a software company which provided software used in analyzing clinical trial data for 13 years.  Over the past 8 years, she has focused on the GCP side of the industry, working with both Sponsors and Contract Research Organizations.  She has served as the Head of Quality for both Sponsors and CROs. 

Deb’s specialties include eTMF set-up /maintenance /review /auditing, clinical compliance, oversight and auditing of GCP service providers, auditing of SaaS vendors, computer system validation and Part 11 compliance, and Inspection Readiness gap assessment and remediation.