TThis poster from SQA’s 2025 Annual Meeting explores the differences between auditors and inspectors in the clinical research industry. From a broad view, auditors focus on quality improvement and compliance verification, while FDA inspectors have the power to enforce laws and take legal action if regulations are not met.  

Senior Quality Auditor Amy Fox dives into the similarities of auditors and inspectors which include regulation enforcement, interviews and evidence collection, reporting, and more. She also notes the differences between auditors and inspectors in various categories such as: authority, purpose, consequences of findings, frequency of work, and more.  

Despite some differences in their roles, both auditors and inspectors play an important role in ensuring compliance.  

Download the poster to learn more!

This poster was first presented at SQA 2025 Annual Meeting and Quality College by Senior Quality Auditor Amy Fox. Amy joined FDAQRC in 2022. She has 20+ years of experience in clinical trial operations and regulatory compliance. Amy holds a Doctor of Health Administration (DHA) and numerous certifications including being a Registered Quality Assurance Professional in Good Clinical Practice (RQAP-GCP).  

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