Lella Baker is a quality-minded professional with over 15 years of pharmaceutical and medical device experience. Lella has expertise in conducting vendor qualification and requalification audits, internal audits and ISA audits. She has completed regulatory filings for ADE drug safety and MDR product complaints. She is also a certified auditor with experience in FDA, MHRA and EU regulations for device and pharmaceutical regulations. Lella is also ASQ/CQA certified. Lella drives research compliance in support of clinical trials through innovative approaches to auditing systems and processes at sponsors and CROs. She earned a Bachelor of Arts degree from Hollins University and completed her graduate work at Andover-Newton - Yale University