In this webinar, the presenter provides more details on how to be best prepared for an external audit (FDA, MDSAP, ISO, etc.), as well as a practical approach to what to do before the audit and common pitfalls based on industry experience. We will also highlight what to expect from FDA inspections following the issued Quality Management System Regulation (QMSR) Final Rule, published on Feb. 2, 2024.
About the presenter
Luana Zerafa, program manager QA/RA
Luana Zerafa is located in the U.K. and has over 15 years of industry experience, working with medical devices and applicable regulations in all classes, including implantable devices, ophthalmic products and medication delivery products. Zerafa specializes in quality engineering and has extensive knowledge in quality system implementation and improvement, as well as compliance with many international standards. Throughout her career in the industry, she has hosted a variety of external audits with certification bodies as well as regulators. As program manager for audits globally within Emergo by UL, Zerafa manages the audit activities internally to ensure auditors have the necessary tools, are adequately trained and all Emergo by UL customers get the best-in-class audit deliverables.
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