# Let's Combinate - Drugs + Devices Page: https://stenobird.com/podcast/let-s-combinate-drugs-devices-4474248 Text version: https://stenobird.com/podcast/let-s-combinate-drugs-devices-4474248.md RSS feed: https://anchor.fm/s/6770b9a0/podcast/rss Official site: https://letscombinate.com Author: Subhi Saadeh Episodes: 261 ## Resource 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! ## Machine-readable JSON: https://stenobird.com/v1/public/podcasts/let-s-combinate-drugs-devices-4474248 Markdown: https://stenobird.com/podcast/let-s-combinate-drugs-devices-4474248.md ## Episodes - [253 - FDA Is Making Big Changes to Its Inspection Approach](https://stenobird.com/podcast/let-s-combinate-drugs-devices-4474248/253-fda-is-making-big-changes-to-its-inspection-approach) — 2026-09-07T10:00:00+00:00 - [252 - Acceptance Sampling Fundamentals: AQL, Attributes vs Variables, and Risk (OC Curves)](https://stenobird.com/podcast/let-s-combinate-drugs-devices-4474248/252-acceptance-sampling-fundamentals-aql-attributes-vs-variables-and-risk-oc-curves) — 2026-08-31T10:00:00+00:00 - [251 - The Future of Drug Delivery: Orals, Injectables, Sustainability & Device Strategy](https://stenobird.com/podcast/let-s-combinate-drugs-devices-4474248/251-the-future-of-drug-delivery-orals-injectables-sustainability-device-strategy) — 2026-08-24T10:00:00+00:00 - [I'm Changing The Podcast](https://stenobird.com/podcast/let-s-combinate-drugs-devices-4474248/i-m-changing-the-podcast) — 2026-08-18T10:00:01+00:00 - [250 - PIC/S PI 006-4 (2026): What Changed in Qualification & Validation?](https://stenobird.com/podcast/let-s-combinate-drugs-devices-4474248/250-pic-s-pi-006-4-2026-what-changed-in-qualification-validation) — 2026-08-12T10:00:00+00:00 - [249 - The Best Audit Advice Nobody Told Me](https://stenobird.com/podcast/let-s-combinate-drugs-devices-4474248/249-the-best-audit-advice-nobody-told-me) — 2026-08-05T10:00:00+00:00 - [248 - What Is a Quality Unit? QA vs. QC Explained](https://stenobird.com/podcast/let-s-combinate-drugs-devices-4474248/248-what-is-a-quality-unit-qa-vs-qc-explained) — 2026-07-29T10:00:00+00:00 - [247 - Why Everyone in Pharma and MedTech Should Work in Quality](https://stenobird.com/podcast/let-s-combinate-drugs-devices-4474248/247-why-everyone-in-pharma-and-medtech-should-work-in-quality) — 2026-07-22T10:00:00+00:00 - [246 - The 3 Ways to Structure a Quality Management System (Centralized vs. Federated vs. Decentralized)](https://stenobird.com/podcast/let-s-combinate-drugs-devices-4474248/246-the-3-ways-to-structure-a-quality-management-system-centralized-vs-federated-vs-decentralized) — 2026-07-15T10:00:00+00:00 - [245 - Reducing a 14-Step Emergency Injection to a Two-Step Auto-Injector](https://stenobird.com/podcast/let-s-combinate-drugs-devices-4474248/245-reducing-a-14-step-emergency-injection-to-a-two-step-auto-injector) — 2026-07-08T10:00:00+00:00 - [244 - 5 Critical Quality Differences Between Drugs and Devices](https://stenobird.com/podcast/let-s-combinate-drugs-devices-4474248/244-5-critical-quality-differences-between-drugs-and-devices) — 2026-07-01T10:00:00+00:00 - [243 - Why Kitting A Finished Medical Device with a Drug Create So Much Work](https://stenobird.com/podcast/let-s-combinate-drugs-devices-4474248/243-why-kitting-a-finished-medical-device-with-a-drug-create-so-much-work) — 2026-06-24T10:00:00+00:00 - [242 - Pharma/MedTech Audits: 6 Strategies for Choosing Where to Start](https://stenobird.com/podcast/let-s-combinate-drugs-devices-4474248/242-pharma-medtech-audits-6-strategies-for-choosing-where-to-start) — 2026-06-17T10:00:00+00:00 - [241 - ICH Q14 Explained: Have We Been Validating Methods Backwards?](https://stenobird.com/podcast/let-s-combinate-drugs-devices-4474248/241-ich-q14-explained-have-we-been-validating-methods-backwards) — 2026-06-10T10:00:00+00:00 - [240 - ICH Q13: Continuous Manufacturing, Batches, Residence Time Distribution and Control Strategy](https://stenobird.com/podcast/let-s-combinate-drugs-devices-4474248/240-ich-q13-continuous-manufacturing-batches-residence-time-distribution-and-control-strategy) — 2026-06-03T10:00:00+00:00 - [239 - ICH Q12: What’s Binding? Established Conditions and Post-Approval Changes](https://stenobird.com/podcast/let-s-combinate-drugs-devices-4474248/239-ich-q12-what-s-binding-established-conditions-and-post-approval-changes) — 2026-05-27T12:24:18+00:00 - [239 - ICH Q11 in 6 Minutes](https://stenobird.com/podcast/let-s-combinate-drugs-devices-4474248/239-ich-q11-in-6-minutes) — 2026-05-20T10:00:00+00:00 - [238 - 6 Audit Strategies Every Auditor Should Know](https://stenobird.com/podcast/let-s-combinate-drugs-devices-4474248/238-6-audit-strategies-every-auditor-should-know) — 2026-05-13T10:00:00+00:00 - [237 - ICH Q10: The Pharmaceutical Quality System](https://stenobird.com/podcast/let-s-combinate-drugs-devices-4474248/237-ich-q10-the-pharmaceutical-quality-system) — 2026-05-06T10:00:00+00:00 - [236: ICH Q9: Quality Risk Management (QRM) + ISO 14971 Differences](https://stenobird.com/podcast/let-s-combinate-drugs-devices-4474248/236-ich-q9-quality-risk-management-qrm-iso-14971-differences) — 2026-04-29T10:00:00+00:00 - [235 - ICH Q8: How Pharmaceutical Development Actually Works](https://stenobird.com/podcast/let-s-combinate-drugs-devices-4474248/235-ich-q8-how-pharmaceutical-development-actually-works) — 2026-04-22T10:00:00+00:00 - [234 - ICH Q7: The GMP Framework for API Manufacturing](https://stenobird.com/podcast/let-s-combinate-drugs-devices-4474248/234-ich-q7-the-gmp-framework-for-api-manufacturing) — 2026-04-15T10:00:00+00:00 - [233 - Most Teams Misunderstand Specifications | ICH Q6](https://stenobird.com/podcast/let-s-combinate-drugs-devices-4474248/233-most-teams-misunderstand-specifications-ich-q6) — 2026-04-08T10:00:00+00:00 - [232 - MedTech Material Selection: Cost, Compliance, Sustainability, and Biocompatibility Risk](https://stenobird.com/podcast/let-s-combinate-drugs-devices-4474248/232-medtech-material-selection-cost-compliance-sustainability-and-biocompatibility-risk) — 2026-04-01T10:00:00+00:00 - [231 - Audit Findings Explained: Nonconformity vs Observation (CQA)](https://stenobird.com/podcast/let-s-combinate-drugs-devices-4474248/231-audit-findings-explained-nonconformity-vs-observation-cqa) — 2026-03-25T10:00:00+00:00 ## Actions Episode pages expose an explicit `request_transcript` action. 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