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Rechercher les épisodes précédents de Let's Combinate - Pharma + Medical Devices with Subhi Saadeh.

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PIC/S has issued its first major update to its qualification and validation recommendations in nearly 20 years. PI 006-4 replaces PI 006-3 from 2007 and brings the document much closer to how qualification and validation are approached today. In this video, I walk through where PI 006-4 fits withi…
In this episode, Subhi Saadeh sits down with Steven Kaufman, Founder of Combination Product Solutions, Inc. and fractional Chief Commercial Officer at Portal Instruments, to discuss where the drug delivery device market is headed and what it takes for new technologies to actually make it to patient…
Audits are not supposed to be gotchas, and they are not meant to evaluate one person’s work in isolation. A good audit looks at whether a system is suitable, effective, and adequate and where it may need to improve. In this video, I share the lessons I learned as I moved from being audited and sup…
What is a Quality Unit and how do Quality Assurance and Quality Control fit within it? In this episode, I explain the practical differences between the Quality Unit, QA, and QC across pharmaceutical, medical-device, and combination-product companies. We’ll look at the Quality Unit’s major responsi…
After 250 straight weeks of publishing Let’s Combinate every Wednesday, I’m making a change. Starting now, new episodes will go live Mondays at 5:00 AM CT. To everyone who watches, listens, shares, or has been part of the journey: thank you. This podcast has been one of the most enriching things …
Avertissement: Le podcast et les illustrations intégrés sur cette page proviennent de Subhi Saadeh, qui est la propriété de son propriétaire et n'est ni affilié ni approuvé par Listen Notes, Inc.