128 - Former FDA Inspector and Managing Consultant, Vin Cafiso: Cadavers/Autopsies, Tales from FDA Inspections, Understanding the QMSR, and Quality Culture
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 Stor...
20 Maalis 202452min
127 - BIG Risk Management Changes in QMSR, Risk Acceptability, Risk Policy & Explaining vs. Justifying Risk Decisions with Naveen Aggarwal
On this episode I was joined by Naveen Aggarwal founder of Creative Analytic Solutions and host of "Let's talk risk". In this episode, Naveen walks through the big changes to risk management with the...
13 Maalis 202448min
126 - Combination Products Collaboration, Turnover on MedTech/Pharma Project Teams, and Lessons from working with Intel's CEO with Mat Stratton, Founder of Coalition Ltd
On this episode I was joined by Mat Straton, Founder of Coalition Ltd. In this episode, Mat discusses: 01:02 Venturing into Combination Products 02:46 Andy's Journey into Healthcare Space 04:48 Chall...
6 Maalis 202435min
125 - Unpacking the Quality Management System Regulation(QMSR) Final Rule with Subhi Saadeh
On this episode, I do an active reading to begin to unpack the Quality Management System Regulations(QMSR) Final Rule that was issued by FDA in early February 2024. 0:00 Introduction 05:09 Initial ...
28 Helmi 202442min
124 - 5 Steps to Becoming a Phenom Quality Pro with Andy Robertson
On this episode, I was joined by Andy Robertson, founder of CQE Academy. In this episode, Andy outlines 5 steps to becoming an exceptional quality engineer, such as seeking mentorship, taking on cha...
21 Helmi 202431min
123 - Uncovering HUGE Quality Issues, Inspection Readiness in 2024, Data Integrity, AlCOA+/PIC/S and Critical Thinking in Quality Management with Peter Baker
On this episode, I was joined by Peter Baker, President @ Live Oak QA. The conversation revolves around the speaker's experience working with the FDA, starting from his time in San Francisco and culm...
14 Helmi 202445min
122 - Intricacies of Joint Audits, Rx360, Supply Chain Security, and Networking in Pharma/MedTech with Jim Fries
On this episode, I was joined by Jim Fries, CEO of Rx360. On this episode, Jim discusses the critical aspects of audits in medical technology and pharmaceutical sectors. He provides insight into the j...
7 Helmi 202435min
121 - Bench Scientist to Commercial Leader, Amgen in the early days, Challenges in Commercialization, Working in Startups vs. Large Companies, and Silos with Sayed Badrawi
On this episode, I was joined by Sayed Badrawi, Pharma/MedTech Investor and Board Member. Sayed walks through starting at Amgen as a bench scientist and transitioning to the commercial side of the Pha...
31 Tammi 202433min
