Let's Combinate - Pharma + Medical Devices with Subhi Saadeh

Combination product quality with Ben Locwin: why drug and device quality systems differ, how human factors studies are designed, what to do when a CDMO's clean audit doesn't match its performance, and how ISO 14971 risk management compares with ICH Q9.
This conversation was recorded for Ben Locwin's Life Science Shifts podcast from Reliant Life Sciences, with Subhi Saadeh as the guest. It covers where pharma and medical device thinking diverge, and what that means when one product has to satisfy both.
IN THIS EPISODE
- Why drugs and devices prove safety and effectiveness in different ways
- Drug development (clinical, nonclinical, CMC) vs. device design controls
- Why the same syringe can need new human factors work for a different user
- How human factors studies are built: patient and caregiver arms, trained and untrained users
- CGMPs for combination products: QMSR, ISO 13485, ICH, and PIC/S
- Global harmonization: IMDRF for devices, ICH for drugs, and the gap for combination products
- CDMO oversight when the supplier scorecard and the audit result don't match what you see
- ISO 14971 and ISO/TR 24971 vs. ICH Q9: initial and updated probability
- FMEA as a living document

TIMESTAMPS
0:00 Pharma vs. medical device quality: two philosophies
2:10 Drug development vs. device design controls
4:29 Why device trials rarely use placebo controls
9:52 Platform technology and delivery devices
12:10 Same device, different user: bracketing and generic platforms
14:14 Human factors studies: recruitment, study arms, formative studies
15:40 CGMPs for combination products: QMSR, ISO 13485, ICH, PIC/S
16:58 Harmonization: IMDRF and ICH
19:12 Conway's Law and organizational inertia
22:06 Staying objective as a consultant
25:10 CDMO oversight: when the scorecard doesn't match reality
30:18 Scoring bias in subjective weighting
31:14 ISO 14971 vs. ICH Q9 risk management
32:32 FMEA as a living document

RELATED VIDEOS

Pharma vs. Medical Device Quality Systems: 5 Differences
https://youtu.be/xG0htEu0ph4

Working with a Device CDMO: Common Sponsor Mistakes
https://youtu.be/d2SDwndXuCk

ICH Q9 Explained
https://youtu.be/Is67hbh71RY

Design Controls Explained for Pharma and Combination Product Teams
https://youtu.be/f7esiLpUhfM

Need help with CDMO oversight, supplier audits, or risk management on a combination product?
https://letscombinate.com/services/

ABOUT BEN LOCWIN

Ben Locwin is Vice President at Reliant Life Sciences and host of the Life Science Shifts podcast. His work spans drug therapies, vaccines, and medical devices, and he is a frequent industry speaker and commentator on pharma and medical device quality.

Reliant Life Sciences:
https://www.reliantlifesciences.com/

ABOUT SUBHI SAADEH
Subhi Saadeh is the Founder and Principal of Let's Combinate, a consultant, auditor, and trainer specializing in drug-device combination products, medical devices, and pharmaceutical quality systems. He has held quality and engineering roles at Pfizer, Gilead, and Baxter, with experience spanning quality, R&D, and commercialization and a focus on design controls, supplier quality, inspection readiness, and translating regulatory expectations into practical execution.

Subhi is an ISO 13485 Lead Auditor and an ASQ Certified Quality Auditor and Certified Quality Engineer. He has chaired the Combination Product Working Group for Rx-360, served as International Committee Chair for the Combination Products Coalition (CPC) and as a member of ASTM Committee E55, and served on AAMI's Combination Products Committee.

CONNECT WITH SUBHI

Consulting, audits, and training:
https://letscombinate.com/services/

Discuss a project:
https://calendly.com/letscombinate/quick-chat

LinkedIn:
https://www.linkedin.com/in/subhi-saadeh-1169aa21/

Email:
subhi@letscombinate.com

FOLLOW LET'S COMBINATE

YouTube:
https://www.youtube.com/@LetsCombinate

Spotify:
https://open.spotify.com/show/71wYadhCrfLsdYTVachpD2

#CombinationProducts #HumanFactors #RiskManagement

21 CFR Part 4 sets the CGMP requirements for combination products. If your product has a drug and a device in it, you're on the hook for both sets of regulations. In this video, I walk through Part 4 Subpart A section by section: the scope, the key definitions, which CGMPs apply, and the two ways to comply, including the streamlined approach under 4.4(b).

Updated for February 2026, when the device side moved to the QMSR and ISO 13485, plus the new medical gas provisions.

Working on your first combination product program? Watch this next: https://youtu.be/uG_Ea__-Pjc

Want a second set of eyes on your combination product quality system? Book a quick call: https://calendly.com/letscombinate/quick-chat

Sources
21 CFR Part 4 (eCFR): https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-4
FDA Guidance, CGMP Requirements for Combination Products: https://www.fda.gov/media/90425/download

Chapters
0:00 Intro
0:50 21 CFR Part 4 Subpart A vs. Subpart B
2:00 Full compliance vs. the streamlined approach
2:39 21 CFR 4.1: Scope (single-entity and co-packaged)
3:52 21 CFR 4.2 and 4.3: Definitions and which CGMPs apply
4:37 21 CFR 4.4: How to comply with CGMPs for combination products
5:38 Drug-based system: ISO 13485 and QMSR provisions to add
7:58 Device-based system: 21 CFR 211 provisions to add
11:24 Medical gas and 4.4(c)–(e): separate facilities
12:10 Wrap-up

About me
I'm Subhi Saadeh. I help companies make drug and device quality systems work together. I'm a consultant, auditor, and trainer focused on combination products, an ISO 13485 Lead Auditor, and an ASQ CQA and CQE. I've worked on prefilled syringes, autoinjectors, IV bags, cartridges, and vial-based systems, from clinical through commercial.

🌐 https://letscombinate.com
📅 https://calendly.com/letscombinate/quick-chat
💼 https://www.linkedin.com/in/subhi-saadeh-1169aa21
✉️ subhi@letscombinate.com

#CombinationProducts #21CFRPart4 #QMSR

QMSR became effective on February 2, 2026. Alongside that change, FDA retired the Quality System Inspection Technique (QSIT) and began using the inspection process described in Compliance Program 7382.850.

What does that mean for industry and how should we use the new program to prepare?

In this episode of Let’s Combinate: Drugs + Devices, Subhi Saadeh introduces a four-part series on QMSR inspection readiness. We compare QSIT’s four major inspection subsystems with the new program’s six QMS areas, explore how risk informs inspection coverage, and identify where industry should start reading.

The episode also features an excerpt from Subhi’s conversation with Eric Pittman, a former FDA investigator who spent a decade as editor-in-chief of FDA’s Investigations Operations Manual.

IN THIS EPISODE
• What replaced QSIT and where to find it
• Why Part III is a useful starting point for industry
• How FDA reorganized inspection coverage into six QMS areas
• How product risks and risk management documentation help guide record selection
• What’s coming in the QMSR inspection readiness series

TIMESTAMPS
00:00 QSIT is gone: What changed with QMSR
00:50 The new FDA inspection program
01:39 The four-part inspection readiness series
02:47 Eric Pittman: Where industry should start
04:14 Will FDA publish a new QSIT guide?
05:06 Comparing the old and new inspection approaches
05:47 Four major subsystems to six QMS areas
06:57 Inspection models and record selection
07:37 Risk, controls, and inspection evidence
08:08 What’s next in the series

THE SERIES
1. QSIT to QMSR: Understanding the new inspection program
2. Inspection models, coverage, and record selection
3. The six QMS areas and how they connect
4. Inspection readiness: Preparing people, processes, and records, with lessons from early QMSR warning letters

RESOURCES

FDA Compliance Program 7382.850 — Inspection of Medical Device Manufacturers
Part III begins on page 20. Attachment A details the QMS areas, elements, and requirements.
https://www.fda.gov/media/80195/download

FDA Investigations Operations Manual — Chapter 5
https://www.fda.gov/media/166533/download

FDA QMSR Frequently Asked Questions
https://www.fda.gov/medical-devices/quality-management-system-regulation-qmsr/quality-management-system-regulation-frequently-asked-questions

ABOUT SUBHI SAADEH

Subhi Saadeh is the Founder and Principal of Let’s Combinate, a consultant, auditor, and trainer specializing in drug-device combination products, medical devices, and pharmaceutical quality systems. His experience spans quality, R&D, and commercialization, with a focus on design controls, supplier quality, inspection readiness, and translating regulatory expectations into practical execution.

Subhi is an ISO 13485 Lead Auditor and an ASQ Certified Quality Auditor and Certified Quality Engineer.

CONNECT WITH SUBHI

Consulting, audits, and training:
https://letscombinate.com

LinkedIn:
https://www.linkedin.com/in/subhi-saadeh-1169aa21/

Schedule a quick chat:
https://calendly.com/letscombinate/quick-chat

Email:
subhi@letscombinate.com

FOLLOW LET’S COMBINATE

YouTube:
https://www.youtube.com/@LetsCombinate

Spotify:
https://open.spotify.com/show/71wYadhCrfLsdYTVachpD2

Apple Podcasts:
https://podcasts.apple.com/us/podcast/lets-combinate-drugs-devices/id1589285792

A huge part of the job is knowing how to interview people, understand how work is actually performed, and corroborate what you hear against records, observations, and other objective evidence.In this episode, I pulled one of the lessons from the auditing course Andy Robertson and I developed and walk through some of the fundamentals of audit interviewing: building rapport, asking open-ended questions, avoiding overly checklist-driven interviews, corroborating information, managing group interviews and translators, and handling some of the situations that make interviews difficult.If documents and records alone were enough to understand the quality of an organization, every audit could be a desktop audit. People are a huge part of what makes an audit work.Full CQA Master Class:https://cqeacademy.teachable.com/p/the-cqa-master-class-courseChapters0:00 Intro1:39 Interviewing Fundamentals3:04 Conversational vs. Checklist3:49 Building Rapport4:29 Focus on the Process5:30 Open-Ended Questions5:58 Corroborating Information6:44 Group Interviews7:29 Using Translators8:20 Interview Challenges10:29 Time Management11:16 ClosingAbout SubhiSubhi Saadeh is the Founder and Principal of 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 pharma, biotech, medical devices, and combination products.Learn more about Let’s Combinate:https://letscombinate.com/Connect with Subhi on LinkedIn:https://www.linkedin.com/in/subhi-saadeh-1169aa21Need help?https://calendly.com/letscombinate/let-s-combinate-intro-session#Quality #Auditing #QualityAssurance #CQA #Pharma #MedicalDevices #CombinationProducts

Quality has a reputation for saying no.

Sometimes that’s exactly the right call. Other times, “no” is just the easiest answer.

In this episode, Subhi breaks down four situations where Quality should absolutely stop the train, and a few where it’s worth stepping back and asking what’s really driving the no in the first place.

Subhi covers:

when there is real patient or product risk
when the evidence doesn’t support the decision
when moving forward would clearly violate requirements or SOPs
when schedule or business pressure is pushing a team to close something that isn’t actually closed

He also talks through some weaker reasons Quality says no, including:

personal preference or “this is how we’ve always done it”
uncertainty from lack of technical familiarity
applying more GMP rigor than the stage of development actually requires

If you work in quality, combination products, development, manufacturing, or technical leadership, this is a practical look at how to think about “no” in a more risk-based way.

Timestamps
00:00 Why Quality Says No
00:45 Channel Intro and Setup
02:02 No When Risk Is Real
03:06 No When Evidence Fails
05:02 No When Requirements Break
05:44 No to Schedule Pressure
07:48 Bad No From Preference
08:33 Bad No From Uncertainty
09:20 Overkill and Phase GMPs
10:08 Build Flexible Quality Culture
12:16 Wrap Up and Takeaways

Subhi Saadeh is a consultant, trainer, auditor, and the Founder and Principal of Let’s Combinate. He has spent his career across medical devices and pharmaceuticals, with experience spanning research and development, industrialization, quality systems, and combination products. Through Let’s Combinate, he helps professionals and organizations better understand and navigate the intersection of drugs, devices, quality, and regulatory requirements.

Connect with Subhi Saadeh
LinkedIn: https://www.linkedin.com/in/subhi-saadeh-1169aa21/
Website: http://letscombinate.com/
Book a quick chat: https://calendly.com/letscombinate/quick-chat
Email: subhi@letscombinate.com

Listen / Follow Let’s Combinate
YouTube: https://www.youtube.com/@LetsCombinate
Spotify: https://open.spotify.com/show/71wYadhCrfLsdYTVachpD2
Apple Podcasts: https://podcasts.apple.com/us/podcast/lets-combinate-drugs-devices/id1589285792

#Quality #CombinationProducts #Pharma #MedTech #RiskManagement #GMP #DesignControls #SupplierQuality #QualitySystems #LetsCombinate