Lori Carr

Expert FDA Consultant

Lori’s QLeaR Advantage

My Why: I really enjoyed being an FDA Medical Device Specialist Investigator and conducting inspections.  I developed usable skills in identifying deficiencies, which translates nicely into my mock FDA inspection work.  The consulting part of what I do today allows me to offer suggestions on correcting my findings, which I could not do as an FDA Investigator.

My Favorite Project: I worked with a client on FDA inspection readiness for nine (9) months, which resulted in the initial PMA pre-market inspection on an implantable medical device having no FDA-483 Inspectional Observation findings.  This was one of the most satisfying professional experiences of my career.  After the FDA Investigator left the inspection, I had tears in my eyes when I talked to my 50-person team and told them how proud I was of their hard work in preparing for this inspection.

Areas of Focus: Mock FDA Quality Management System (QMS), GCP (BIMO), GCP inspections; Certified in EU MDR, MDSAP, and ISO 13485-2016 auditing. FDA-483 and Warning Letter Certification Audits. QMS FDA Remediation. Certified FDA Medical Device Specialist Investigator, FDA Inspection Readiness / EU MDR, ISO 13485:2016, and MDASAP Audit. Domestic and Internationals 510(k), PMA and Routine QMS Inspections

Years of Experience: 30

Education & Certifications: 

• B.S., Chemistry
• RAC/US (RAPS) Medical Devices / Drugs
• CQA (ASQ)
• ISO 13485:2016 Principal Auditor
• RABS QA Principal
• MDSAP & EU MDR Lead Auditor