Let's Combinate - Drugs + Devices

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

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

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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

FDA is changing how it organizes and deploys its investigators but it isn’t simply returning to the old generalist model.
Eric Pittman spent more than 20 years at FDA, conducted approximately 800+ inspections, led the Bioresearch Monitoring Division West, and served for a decade as editor-in-chief of FDA’s Investigations Operations Manual.
In this episode, Eric explains how FDA investigators are trained to think, the difference between technical expertise and inspection skill, why investigators sometimes “phone home,” and what the transition from ORA to OII means for the agency’s inspection model.
We also discuss BIMO inspections, the difference between inspections and investigations, the end of QSIT, and how companies can use FDA’s Investigations Operations Manual and compliance programs to prepare more effectively.
Timestamps
00:00 Introduction
00:48 FDA’s generalist and specialist inspection models
03:52 What is Bioresearch Monitoring (BIMO)?
05:03 What makes someone an effective FDA investigator?
08:39 Technical expertise versus auditing and inspection skills
11:25 What FDA investigators are actually looking for
14:07 Eric’s experience conducting 800–1,000 inspections
15:11 How investigators prepare, inspect, and write reports
19:44 Why FDA investigators sometimes “phone home”
23:35 The transition from ORA to OII
28:00 What responsibilities remain within OII?
30:31 FDA inspections versus investigations
33:05 The IOM, QSIT, and investigator discretion
38:25 How industry should use FDA compliance programs
44:13 What companies waste time preparing for
45:55 Where to find Eric
About Eric Pittman
Eric Pittman is Vice President of Quality Assurance and Regulatory Affairs at Project Farma. Before moving into industry, he spent more than 20 years at FDA across drugs, devices, foods, biologics, and bioresearch monitoring.
He served as Division Director for Bioresearch Monitoring West, was the U.S. delegate to the OECD Working Party on Good Laboratory Practice, and spent a decade as editor-in-chief of FDA’s Investigations Operations Manual. Eric is also an adjunct professor in Temple University’s QA/RA graduate program.
Connect with Eric
LinkedIn: https://www.linkedin.com/in/ericspittmanmba-fda
Project Farma: https://projectfarma.com
About Subhi Saadeh
Subhi Saadeh is a combination-product quality professional, consultant, and host of Let’s Combinate: Drugs + Devices. His work focuses on the intersection of pharmaceutical and medical-device requirements, including combination-product quality systems, design controls, supplier quality, manufacturing, inspection readiness, and regulatory strategy.
Through Let’s Combinate, Subhi brings together regulators, industry leaders, and technical experts to make complex drug-device topics easier to understand and apply.
Connect with Subhi
LinkedIn: https://www.linkedin.com/in/subhi-saadeh-1169aa21/
YouTube: https://www.youtube.com/@LetsCombinate
Website: https://letscombinate.com

Acceptance sampling is one of the most commonly used and commonly misunderstood tools in quality.

In this video, I break down the fundamentals of acceptance sampling: what it is, what an AQL actually means, the difference between sampling by attributes and variables, and the risk involved when we use a sample to make an accept/reject decision about an entire lot.

We’ll also introduce Operating Characteristic (OC) curves, producer risk, and consumer risk — because acceptance sampling is probability-based and every sampling plan comes with tradeoffs.

This is the first video in a series on acceptance sampling. Future videos will go deeper into attribute sampling, variable sampling, and how to select and apply sampling plans in practice.

Topics Covered:
* What acceptance sampling is
* Why acceptance sampling is probability-based
* AQL — Acceptance Quality Limit
* Why AQL does not simply mean “allowable percent defective”
* Attribute vs. variable acceptance sampling
* ISO 2859-1 / ANSI-ASQ Z1.4
* ISO 3951 / ANSI-ASQ Z1.9
* Operating Characteristic (OC) curves
* Producer risk vs. consumer risk
* How overly tight or overly loose sampling plans can create problems

Chapters

00:00 Introduction
01:30 Why Acceptance Sampling Matters
01:45 Perfect World vs. Reality
02:49 What Is Acceptance Sampling?
03:53 Attributes vs. Variables
05:21 What Is AQL?
07:05 Risk & the OC Curve
09:57 Producer & Consumer Risk
12:05 Practical Takeaway

About Subhi Saadeh

Subhi Saadeh is the Founder and Principal of Let’s Combinate, an independent media, education, and consulting company focused on drug device combination products, quality systems, and quality engineering.

Subhi is a consultant, trainer, and auditor with a background spanning R&D, industrialization, commercialization, and quality across the pharmaceutical and medical device industries.

He is also the host of Let’s Combinate: Drugs + Devices where he talks with industry leaders and breaks down complex quality, regulatory, device, pharma and combination-product topics.

**Need help with consulting, training, or auditing?**
Learn more at: [https://www.letscombinate.com](https://www.letscombinate.com)

**Connect with Subhi:**
LinkedIn: [https://www.linkedin.com/in/subhi-saadeh-1169aa21](https://www.linkedin.com/in/subhi-saadeh-1169aa21)
Email: [subhi@letscombinate.com](mailto:subhi@letscombinate.com)

#AQL #AcceptanceSampling #QualityEngineering #Pharma #MedicalDevices #CombinationProducts #ISO2859 #ISO3951