Podcast

Let's Combinate - Drugs + Devices

Author: Subhi Saadeh
Feed episode count: 261
Official site: https://letscombinate.com
RSS: https://anchor.fm/s/6770b9a0/podcast/rss
JSON: /v1/public/podcasts/let-s-combinate-drugs-devices-4474248
Markdown: /podcast/let-s-combinate-drugs-devices-4474248.md

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!

Episodes

Sep 7, 2026 · not_requested

253 - FDA Is Making Big Changes to Its Inspection Approach

Duration seconds: 2753
Source: https://podcasters.spotify.com/pod/show/letscombinate/episodes/253---FDA-Is-Making-Big-Changes-to-Its-Inspection-Approach-e3oe86q

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Aug 31, 2026 · not_requested

252 - Acceptance Sampling Fundamentals: AQL, Attributes vs Variables, and Risk (OC Curves)

Duration seconds: 786
Source: https://podcasters.spotify.com/pod/show/letscombinate/episodes/252---Acceptance-Sampling-Fundamentals-AQL--Attributes-vs-Variables--and-Risk-OC-Curves-e3o44b6

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Aug 24, 2026 · not_requested

251 - The Future of Drug Delivery: Orals, Injectables, Sustainability & Device Strategy

Duration seconds: 2969
Source: https://podcasters.spotify.com/pod/show/letscombinate/episodes/251---The-Future-of-Drug-Delivery-Orals--Injectables--Sustainability--Device-Strategy-e3np4sc

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Aug 18, 2026 · not_requested

I'm Changing The Podcast

Duration seconds: 167
Source: https://podcasters.spotify.com/pod/show/letscombinate/episodes/Im-Changing-The-Podcast-e3nj021

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Aug 12, 2026 · not_requested

250 - PIC/S PI 006-4 (2026): What Changed in Qualification & Validation?

Duration seconds: 675
Source: https://podcasters.spotify.com/pod/show/letscombinate/episodes/250---PICS-PI-006-4-2026-What-Changed-in-Qualification--Validation-e3n9m1r

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Aug 5, 2026 · not_requested

249 - The Best Audit Advice Nobody Told Me

Duration seconds: 869
Source: https://podcasters.spotify.com/pod/show/letscombinate/episodes/249---The-Best-Audit-Advice-Nobody-Told-Me-e3mvrbf

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Jul 29, 2026 · not_requested

248 - What Is a Quality Unit? QA vs. QC Explained

Duration seconds: 534
Source: https://podcasters.spotify.com/pod/show/letscombinate/episodes/248---What-Is-a-Quality-Unit--QA-vs--QC-Explained-e3mm6oe

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Jul 22, 2026 · not_requested

247 - Why Everyone in Pharma and MedTech Should Work in Quality

Duration seconds: 497
Source: https://podcasters.spotify.com/pod/show/letscombinate/episodes/247---Why-Everyone-in-Pharma-and-MedTech-Should-Work-in-Quality-e3mcirn

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Jul 15, 2026 · not_requested

246 - The 3 Ways to Structure a Quality Management System (Centralized vs. Federated vs. Decentralized)

Duration seconds: 536
Source: https://podcasters.spotify.com/pod/show/letscombinate/episodes/246---The-3-Ways-to-Structure-a-Quality-Management-System-Centralized-vs--Federated-vs--Decentralized-e3m3g06

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Jul 8, 2026 · not_requested

245 - Reducing a 14-Step Emergency Injection to a Two-Step Auto-Injector

Duration seconds: 2712
Source: https://podcasters.spotify.com/pod/show/letscombinate/episodes/245---Reducing-a-14-Step-Emergency-Injection-to-a-Two-Step-Auto-Injector-e3lo25b

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Jul 1, 2026 · not_requested

244 - 5 Critical Quality Differences Between Drugs and Devices

Duration seconds: 529
Source: https://podcasters.spotify.com/pod/show/letscombinate/episodes/244---5-Critical-Quality-Differences-Between-Drugs-and-Devices-e3lg88e

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Jun 24, 2026 · not_requested

243 - Why Kitting A Finished Medical Device with a Drug Create So Much Work

Duration seconds: 878
Source: https://podcasters.spotify.com/pod/show/letscombinate/episodes/243---Why-Kitting-A-Finished-Medical-Device-with-a-Drug-Create-So-Much-Work-e3l6s0r

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Jun 17, 2026 · not_requested

242 - Pharma/MedTech Audits: 6 Strategies for Choosing Where to Start

Duration seconds: 730
Source: https://podcasters.spotify.com/pod/show/letscombinate/episodes/242---PharmaMedTech-Audits-6-Strategies-for-Choosing-Where-to-Start-e3ksv8t

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Jun 10, 2026 · not_requested

241 - ICH Q14 Explained: Have We Been Validating Methods Backwards?

Duration seconds: 629
Source: https://podcasters.spotify.com/pod/show/letscombinate/episodes/241---ICH-Q14-Explained-Have-We-Been-Validating-Methods-Backwards-e3kj7lg

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Jun 3, 2026 · not_requested

240 - ICH Q13: Continuous Manufacturing, Batches, Residence Time Distribution and Control Strategy

Duration seconds: 668
Source: https://podcasters.spotify.com/pod/show/letscombinate/episodes/240---ICH-Q13-Continuous-Manufacturing--Batches--Residence-Time-Distribution-and-Control-Strategy-e3k8o4c

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May 27, 2026 · not_requested

239 - ICH Q12: What’s Binding? Established Conditions and Post-Approval Changes

Duration seconds: 645
Source: https://podcasters.spotify.com/pod/show/letscombinate/episodes/239---ICH-Q12-Whats-Binding--Established-Conditions-and-Post-Approval-Changes-e3jt5h6

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May 20, 2026 · not_requested

239 - ICH Q11 in 6 Minutes

Duration seconds: 366
Source: https://podcasters.spotify.com/pod/show/letscombinate/episodes/239---ICH-Q11-in-6-Minutes-e3jke8m

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May 13, 2026 · not_requested

238 - 6 Audit Strategies Every Auditor Should Know

Duration seconds: 604
Source: https://podcasters.spotify.com/pod/show/letscombinate/episodes/238---6-Audit-Strategies-Every-Auditor-Should-Know-e3j9ttg

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May 6, 2026 · not_requested

237 - ICH Q10: The Pharmaceutical Quality System

Duration seconds: 492
Source: https://podcasters.spotify.com/pod/show/letscombinate/episodes/237---ICH-Q10-The-Pharmaceutical-Quality-System-e3iuvhf

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Apr 29, 2026 · not_requested

236: ICH Q9: Quality Risk Management (QRM) + ISO 14971 Differences

Duration seconds: 736
Source: https://podcasters.spotify.com/pod/show/letscombinate/episodes/236-ICH-Q9-Quality-Risk-Management-QRM--ISO-14971-Differences-e3ik4d1

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Apr 22, 2026 · not_requested

235 - ICH Q8: How Pharmaceutical Development Actually Works

Duration seconds: 649
Source: https://podcasters.spotify.com/pod/show/letscombinate/episodes/235---ICH-Q8-How-Pharmaceutical-Development-Actually-Works-e3i9408

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Apr 15, 2026 · not_requested

234 - ICH Q7: The GMP Framework for API Manufacturing

Duration seconds: 835
Source: https://podcasters.spotify.com/pod/show/letscombinate/episodes/234---ICH-Q7-The-GMP-Framework-for-API-Manufacturing-e3htt99

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Apr 8, 2026 · not_requested

233 - Most Teams Misunderstand Specifications | ICH Q6

Duration seconds: 417
Source: https://podcasters.spotify.com/pod/show/letscombinate/episodes/233---Most-Teams-Misunderstand-Specifications--ICH-Q6-e3hj6e4

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Apr 1, 2026 · not_requested

232 - MedTech Material Selection: Cost, Compliance, Sustainability, and Biocompatibility Risk

Duration seconds: 2054
Source: https://podcasters.spotify.com/pod/show/letscombinate/episodes/232---MedTech-Material-Selection-Cost--Compliance--Sustainability--and-Biocompatibility-Risk-e3h8k0t

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Mar 25, 2026 · not_requested

231 - Audit Findings Explained: Nonconformity vs Observation (CQA)

Duration seconds: 718
Source: https://podcasters.spotify.com/pod/show/letscombinate/episodes/231---Audit-Findings-Explained-Nonconformity-vs-Observation-CQA-e3gu8jk

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