Former FDA — Quality Systems Specialist
Lisa Hornback
Regarded at FDA as an expert in both medical device and pharmaceutical quality systems; guides firms out of Warning Letters and Consent Decrees.
- QMSR
- cGMP
- ISO 13485
- Warning Letter
- Quality Systems
30+ years FDA and industry
Background
Lisa Hornback has more than 30 years of combined FDA and industry experience with both pharmaceutical and medical device firms. She is an expert in QMSR, GMP and ISO compliance, and has guided companies through the resolution of Warning Letters and Consent Decrees by implementing quality systems that are both successful and compliant.
While at the FDA, Lisa was considered an expert in medical device and pharmaceutical quality systems alike — an unusually broad footing that lets her reconcile device and drug requirements inside a single organization.
What Lisa does on an engagement
- QMSR, GMP and ISO 13485 compliance assessment
- Warning Letter and Consent Decree remediation
- Quality system design and rebuild
- Combination product and dual-system harmonization
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.