178 - CAPA Face-Off: Pharma vs. MedTech – Key Differences You Need to Know

https://is1-ssl.mzstatic.com/image/thumb/Podcasts221/v4/94/95/e0/9495e06e-b2a9-813f-0bc3-51e94ac65dd7/mza_3974126336408920497.jpg/600x600bb.jpg

Let's Combinate - Drugs + Devices

Subhi Saadeh

182 episodes

2 days ago

Hello Combi-Nation! Our industry fee complicated sometimes. Drugs, devices, clinical trials, submissions, sterilization validation, design control, risk management, market access reimbursement, the list goes on. My name is Subhi Saadeh. I've spent over a decade in medical device, pharma, and combination product development. My goal is mastery, so this podcast is to ask questions I have to people who may have the answers. Whether you're background is Pharma, Device or both, I invite you to listen and together we can simplify by Combinating!

Life Sciences

Science

RSS

All content for Let's Combinate - Drugs + Devices is the property of Subhi Saadeh and is served directly from their servers with no modification, redirects, or rehosting. The podcast is not affiliated with or endorsed by Podjoint in any way.

Life Sciences

Science

https://d3t3ozftmdmh3i.cloudfront.net/staging/podcast_uploaded_nologo/17254408/17254408-1735275370987-64c671ec88d89.jpg

178 - CAPA Face-Off: Pharma vs. MedTech – Key Differences You Need to Know

Let's Combinate - Drugs + Devices

31 minutes 22 seconds

1 week ago

178 - CAPA Face-Off: Pharma vs. MedTech – Key Differences You Need to Know

In this episode of Let's Combinate, host Subhi Saadeh is joined by quality systems expert Aaron Snyder to explore the critical quality system element known as CAPA (Corrective and Preventive Action).

They dive into the differences between CAPA approaches in the pharmaceutical and MedTech industries, examining their historical and regulatory contexts. Aaron explains how U.S. regulations describe deviations on the pharma side and non-conforming products on the MedTech side, and how these are handled differently under respective quality systems.

The conversation also touches on topics like root cause analysis, verification of effectiveness, and the importance of management support in making CAPA systems effective. Aaron highlights the value of continuous improvement and debunks common misconceptions about CAPA in both industries.

00:00 Introduction and Guest Introduction

00:33 Understanding CAPA in Pharma and MedTech

01:08 Regulatory Differences and Their Implications

03:12 Event Handling and Investigation Processes

08:13 CAPA System Effectiveness

13:57 Quality System Approaches in Pharma and MedTech

26:22 Root Cause Analysis and Continuous Improvement

30:43 Conclusion and Contact Information

Aaron Snyder is a quality management systems expert and the founder of Quality Systems Explained. He previously served as VP of QA at Allotex and has held roles at Fresenius Kabi, Molnlycke, Waters Corporation, Covidien, Cardinal Health, and General Electric. With extensive experience across pharmaceuticals, medical devices, and combination products, Aaron is also a member of the AAMI Faculty, teaching several courses on various QMS topics. An avid content creator, he dissects, presents, and teaches QMS and cGMP topics on his YouTube channel, Quality Systems Explained.

Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.