130 - QMSR Changes to Traceability/Reporting, Independent Reviewer & Risk Management, Learning New Regulations and MDSAP with Aaron Snyder

Combinate Podcast - Combining Drugs and Devices

A tartalmat a Subhi Saadeh biztosítja. Az összes podcast-tartalmat, beleértve az epizódokat, grafikákat és podcast-leírásokat, közvetlenül a Subhi Saadeh vagy a podcast platform partnere tölti fel és biztosítja. Ha úgy gondolja, hogy valaki az Ön engedélye nélkül használja fel a szerzői joggal védett művét, kövesse az itt leírt folyamatot https://hu.player.fm/legal.

1M ago 32:25

MP3•Epizód kép

On this episode I was joined by Aaron Snyder, VP of Quality Assurance at Allotex. Aaron discusses:

00:58 Exploring the Impact of QMSR on Medical Device Companies

02:19 UDI Regulations

05:18 Understanding the FDA's Approach to QMSR and Compliance

18:02 The FDA's Inspection Techniques and the Future of QMSR

31:55 Where to Find Aaron and Closing Thoughts

Aaron Snyder is a quality management systems expert and is the 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.

138 epizódok

#Science #Biology #Subhi Saadeh