{"podcast":{"title":"Let's Combinate - Drugs + Devices","slug":"let-s-combinate-drugs-devices-4474248","podcast_index_feed_id":4474248,"rss_url":"https://anchor.fm/s/6770b9a0/podcast/rss","website_url":"https://letscombinate.com","image_url":"https://d3t3ozftmdmh3i.cloudfront.net/staging/podcast_uploaded_nologo/17254408/17254408-1735275370987-64c671ec88d89.jpg","author":"Subhi Saadeh","episode_count":261,"summary":"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!","last_synced_at":"2026-09-07T22:17:41.545168+00:00","page_url":"https://stenobird.com/podcast/let-s-combinate-drugs-devices-4474248"},"episode":{"title":"239 - ICH Q11 in 6 Minutes","slug":"239-ich-q11-in-6-minutes","published_at":"2026-05-20T10:00:00+00:00","page_url":"https://stenobird.com/podcast/let-s-combinate-drugs-devices-4474248/239-ich-q11-in-6-minutes","show_page_url":"https://stenobird.com/podcast/let-s-combinate-drugs-devices-4474248","url":"https://podcasters.spotify.com/pod/show/letscombinate/episodes/239---ICH-Q11-in-6-Minutes-e3jke8m","audio_url":"https://anchor.fm/s/6770b9a0/podcast/play/120256214/https%3A%2F%2Fd3ctxlq1ktw2nl.cloudfront.net%2Fstaging%2F2026-4-20%2F424509474-44100-2-6f504f3843151.mp3","summary":"In this episode, Subhi breaks down Q11 by focusing on three key sections: how the drug substance process is developed, where that process begins, and how it is controlled. He places Q11 in context with Q7 for API GMP, Q8 for pharmaceutical development, Q9 for quality risk management, and Q10 for the pharmaceutical quality system. The episode covers Section 3 on manufacturing process development, Section 5 on starting materials, and Section 6 on control strategy beyond release testing. In the next episode, Subhi will cover ICH Q12. Timestamps 00:00 ICH Q11 overview 00:47 Drug substance basics 01:14 Where Q11 fits in the ICH Quality framework 02:15 Section 3: Manufacturing process development 03:26 Linking drug substance quality to drug product quality 04:25 Section 5: Starting materials 05:41 Section 6: Control strategy 06:11 Wrap-up and next episode Subhi Saadeh is the Founder and Principal at Let’s Combinate, where he helps teams develop and control drug-device combination products by aligning quality systems, development, and regulatory expectations across drug and device domains. He is a consultant, auditor, trainer, and speaker with experience across Pfizer, Gilead, and Baxter, supporting the development and launch of combination products across vaccines, biologics, and generics.","meta_description":"In this episode, Subhi breaks down Q11 by focusing on three key sections: how the drug substance process is developed, where that process begins, and how…","key_points":[],"chapters":[],"topics":[],"duration_seconds":366,"processing_state":"not_requested","actions":[{"name":"request_transcript","method":"POST","url":"https://stenobird.com/v1/public/podcasts/let-s-combinate-drugs-devices-4474248/episodes/239-ich-q11-in-6-minutes/transcription-requests","description":"Idempotently request low-priority transcript generation for this episode."},{"name":"read_markdown","method":"GET","url":"https://stenobird.com/podcast/let-s-combinate-drugs-devices-4474248/239-ich-q11-in-6-minutes.md","description":"Read the agent-friendly Markdown representation of this episode resource."}]}}