128 - Former FDA Inspector and Managing Consultant, Vin Cafiso: Cadavers/Autopsies, Tales from FDA Inspections, Understanding the QMSR, and Quality Culture

Let's Combinate - Combining Drugs and Devices

On this episode, I was joined by Former FDA Investigator and Managing Consultant of Practical Compliance Results, Vin Cafiso.

Vin discusses:

01:35 Journey from Premed to FDA Investigator: VIN's Story

07:25 Understanding the Impact of QMSR on Industry

16:24 The FDA's Approach to Inspections and Compliance

27:45 The Shift Towards Quality Culture in FDA Inspections

31:07 Real-World Insights

35:34 The Impact of Quality Culture on Inspections

44:22 Transitioning from FDA to Industry

49:51 Building a Career in Quality Engineering

Vincent (Vin) Cafiso, serves as the Founder and Managing Consultant of Practical Compliance Solutions. His professional journey commenced as an FDA investigator, after which he transitioned into the industry. Throughout his career, he has held diverse positions at well-established medical device companies such as BD, Smith & Nephew, BioArray Solutions, and Impulse Dynamics. He consults on medical device quality management and can be reached on linkedin here or via the web on https://practicalcomplianceresults.com/about