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JOEY ECKENFELS

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Joey is a seasoned quality and regulatory professional with over 16 years of experience in the pharmaceutical and medical device industries. He has excelled as a Lead Auditor and held key roles such as Director of Audits and Head of Quality. With a Master's degree in Regulatory Science (MS), he ensures compliance with quality management system (QMS) standards, including ISO 9001/13485/14971, IEC 62304 (SaMD), and FDA QMSR, along with regulatory requirements in the USA (21CFR820), EU (MDR, IVDR), Canada (CMDCAS), and MDSAP.

Joey has played a pivotal role in both start-up and multi-site global organizations, implementing and overseeing essential quality functions. His experience includes working closely with audits related to FDA 483s, Warning Letters, and Consent Decrees, showcasing his expertise in navigating complex regulatory challenges. Joey is committed to maintaining the highest levels of compliance and regulatory excellence.

As an instructor, he offers training in areas such as Design Controls, Risk Management, Audit, CAPA, and EU MDR 2017/745. Joey also excels in conducting gap assessments and crafting quality plans to drive quality and regulatory initiatives to success. He has led four organizations through the transition from EU MDD to EU MDR. With his unique experience, leadership, and advanced education in Regulatory Science, Joey provides expert guidance in the pharmaceutical and medical device industries.

 

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