092 - Putting it all together: Drug cGMP’s 210/211/ICH and Device QMS 820/ISO13485 with Aaron Snyder

On this episode I was joined by Aaron Snyder, VP of Quality Assurance at Allotex. Aaron discusses: • Distinguishing differences in framework between the Device QSR/QMS and Drug cGMP’s • Learnings from Training FDA CDER and CBER on device requirements • Lessons from being Head of QA at a manufacturing site and internal audit • Teaching through AAMI and his YouTube channel: Quality Systems Explained Aaron Snyder is a quality management systems expert and is currently VP of QA at Allotex. Prior to joining Allotex, Aaron served in roles at Fresenius Kabi, Molnlycke, Waters Corporation, Covidien, Cardinal Health, and General Electric. He has worked with a wide range of pharmaceuticals, medical devices and combination products. Aaron is a member of the AAMI Faculty and teaches several courses focused on various QMS topics. Aaron is also and avid content creator and dissects, presents and teaches on QMS and cGMP’s topics on his YouTube channel: Quality Systems Explained.