Industry experts
Specialists who have run these systems from the inside
Alongside our former FDA professionals, xFDA engagements draw on senior industry practitioners — quality assurance, business management, computer system validation, clinical research and GCP.
The bench
Operating experience, not observation
These are the people who wrote the protocols, closed the deviations, validated the systems and answered for them during audits.
Shane Snoeberger, MBA, ASQ CQE
Vice President & Business Management Services Director
Quality and operations leader, certified quality engineer and Lean Six Sigma Black Belt with deep DEA registration expertise.
20+ years in FDA- and DEA-regulated industry
Deena Venezia, MBA
Computer System Validation & Compliance Specialist
Computer system and LIMS validation, gap assessments, and running the back room during FDA audits.
25+ years in pharmaceutical and device industry
Gregory Jean-Noel, MD, MBA
Clinical Medical Director & Quality Control Specialist
Physician who has overseen projects from product development through FDA submission and provides risk assessments on complaints and early development.
Many years of pharmaceutical industry experience
Robert Fannon, MBA
Clinical Research & GCP Specialist
All phases of pharmaceutical and device clinical trials, with mock-FDA audits across GCP, GXP and GLP and extensive international audit experience.
30+ years industry
Jaclyn Snoeberger, QA Associate II
Quality Assurance & Project Support
Complaint system remediation, change control, APRs, batch record review, product release and document control.
10 years in pharmaceutical and device industry
Also on the team
Former FDA investigators and compliance officers
Most engagements pair an industry specialist with a former FDA professional so the technical work and the regulatory reading of it happen together.
Start a project
Tell us what you're working on.
Describe the product, the process or the problem. We will tell you honestly whether we are the right people to help, and who should be on the team if we are.