128 - Former FDA Inspector and Managing Consultant, Vin Cafiso: Cadavers/Autopsies, Tales from FDA Inspections, Understanding the QMSR, and Quality Culture
Description
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
On this episode, I was joined by one of my favorite guests, Larry Mager of Mgmt-Ctrl and PQMCoach.com. Larry walks through:
00:31 Larry's Perspective on Quality
03:21 Importance of KPIs in Management Review
04:13 Management Review and Control
09:09 Operational Framework and Business...
Published 05/29/24
On this episode I was joined by Captain Alan Stevens, Global Head of Complex Devices and Drug Delivery Systems at AbbVie. In this episode, Alan walks through:
00:38 Exploring Reliability in Combination Products
01:17 The Importance of Subscribing and Feedback
01:36 Alan Stevens Shares His...
Published 05/22/24