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Let’s Combinate – Combining Drugs and Devices

088 - Production Part Approval Process(PPAP) with Subhi Saadeh

22 min • 7 juni 2023

On this episode, I outline an introduction to one of my favorite APQP tools, Production Part Approval Process(PPAP):


- What is PPAP

- Inputs, Process, Triggers and Interactions

- PPAP Elements and Tools

- The difference between first article inspection(FAI) and Capability Studies

- Applications and Challenges in use


Subhi Saadeh is a Quality Professional and host of the Combinate Podcast. 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.


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