Let's Combinate - Drugs + Devices

Por: Subhi Saadeh
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!
224 episodios disponibles

Latest episodes of the podcast Let's Combinate - Drugs + Devices

219 - FDA PreCheck and the Future of Inspections: PAI to Pre-Readiness 24/12/2025
218 - ICH Q13: Continuous Manufacturing EXPLAINED (Batch vs. Continuous) 17/12/2025
217 - 5 Fixable Problems Holding Back Drug–Device Programs 10/12/2025
216 - How UAE and Singapore Are Redefining Regulatory Innovation with Stephen O'Rourke 03/12/2025
215 - Why Aren’t Technical People Leading Drug-Device Audits? 26/11/2025
214 - The Best 5 Certifications for ANY Quality Career Path (CQE, Green Belt, CQA & More) 19/11/2025
213 - From Generic Underdog to Billion‑Dollar Exit: How Usman Ahmed Built & Sold a Sterile Injectable Site 12/11/2025
212 - What 6 of the World’s Biggest Companies Taught Him About Combination Products 05/11/2025
211 - Inside FDA’s Office of Combination Products: History, PMOA, and What’s Next for Combination Products with Mark Kramer 30/10/2025
210 - The 8 Roles You MUST Understand in Pharma & MedTech 22/10/2025
210 - How AI Is Rewriting GMP: Smarter CAPA, PAT, DOE, and Continuous Yield 15/10/2025
209 - ALCOA++ EXPLAINED | What Everyone Gets Wrong About Data Integrity with Monika Andraos 08/10/2025
208 - How Drugs Are Designed, Targets, Phenotypes, and Structure Based Design 01/10/2025
207 - What 99.999% Reliability Really Means 24/09/2025
206 - Will AI Decide Your Next Drug/Device Approval? 17/09/2025
205 - Why Less Than 20% of Companies Have Started Quality 4.0 11/09/2025
204 - The Dictionary & Thesaurus of Combination Products (Finally Explained) with Susan Neadle 03/09/2025
203 - Drug Delivery, Platforms, IP Battles, Supply Chain Risks with Jim Collins 27/08/2025
202 - Becoming an Expert in the Work Nobody Wants to Do/Design, Risk, and the Messy Middle of Combination Products w/Joey Frechin 20/08/2025
201 - Inside a $300M FDA Remediation, Lessons from Zimmer to EpiPen Warning Letters, 99.999% Reliability and Quality 4.0 13/08/2025
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