Let's Combinate - Drugs + Devices with Subhi Saadeh

What is a Quality Unit and how do Quality Assurance and Quality Control fit within it?

In this episode, I explain the practical differences between the Quality Unit, QA, and QC across pharmaceutical, medical-device, and combination-product companies. We’ll look at the Quality Unit’s major responsibilities, why QA is generally system- and process-focused, why QC is generally testing- and product-focused, and why the organizational structure varies between companies.

CHAPTERS

00:00 What is a Quality Unit?

01:18 The Quality Unit as the umbrella function

01:55 Three major Quality Unit responsibilities

03:08 What functions may sit within Quality

04:08 Establishing, operating, and releasing

04:37 Quality Assurance vs. Quality Control

05:38 Common QA responsibilities

06:16 Common QC responsibilities

06:53 Why pharma and device companies look different

07:32 Drug vs. device terminology

08:06 How QC supports product release

08:26 Final QA vs. QC summary

KEY TAKEAWAYS

• The Quality Unit provides overall quality oversight.

• QA primarily focuses on systems and processes.

• QC primarily focuses on inspection, measurement, and testing.

• QC testing provides essential evidence supporting product disposition.

• Exact responsibilities and reporting structures vary by company and industry.

How are QA and QC organized at your company? Share your experience in the comments.

#QualityAssurance #QualityControl #QualityUnit #Pharma #MedicalDevices #qualitymanagement

Subhi Saadeh is a quality professional, consultant, auditor, and trainer who specializes in drug-device combination products, medical devices, pharmaceutical quality systems, supplier quality, and lifecycle management.

Through Let’s Combinate, he helps pharmaceutical and medical device teams bridge the gap between drug and device quality, regulatory expectations, and practical execution.

Learn more about Let’s Combinate:

https://www.letscombinate.com

Schedule an introductory call:

https://calendly.com/letscombinate/let-s-combinate-intro-session

Connect with Subhi on LinkedIn:

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

Listen to Let’s Combinate on Apple Podcasts:

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

Listen on Spotify:

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

Quality is often treated like a necessary function rather than an exciting career path. But working in quality can give professionals in pharma, biotech, and MedTech a much broader understanding of how regulated businesses actually operate.

In this video, Subhi Saadeh explains three reasons everyone in the industry should consider spending time in quality:

You learn how the business works. Quality follows the product across its lifecycle from development and suppliers through manufacturing, operations, regulatory changes, and post-market activities.

You develop judgment. Quality professionals regularly make structured, risk-based decisions in gray areas and document those decisions so they can withstand audits, inspections, and future review.

You learn to influence without owning everything. Quality is often accountable for outcomes without directly controlling every activity, which requires strong questions, clear communication, and the ability to help teams navigate competing priorities.

Even if you do not spend your entire career in quality, the experience can make you a stronger decision-maker, collaborator, and leader throughout the rest of your career.

00:00 Why Quality Matters

00:35 Why Work in Quality

01:41 Reason One: Learn How the Business Works

02:47 Reason Two: Make Defensible Decisions

05:23 Reason Three: Influence Without Authority

07:43 Key Takeaways

About Subhi

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 the intersection of drugs, devices, quality, and regulatory requirements.

Most discussions about One QMS focus on harmonization.

But before deciding whether a single global Quality Management System is the right approach, it's worth understanding the three primary ways organizations structure a QMS.

In this episode, I compare centralized, decentralized, and federated (hybrid) Quality Management System models, including the trade-offs of each in terms of ownership, standardization, flexibility, governance, and decision-making.

We also walk through how the document hierarchy typically differs across each model—from the Quality Policy and Quality Manual to standards, SOPs, work instructions, and records—and discuss why governance often has a greater impact on success than the operating model itself.

Timestamps

00:00 Why "One QMS" Is Trending

01:33 The Three Primary QMS Models

01:50 Centralized QMS

02:01 Decentralized QMS

02:28 Federated (Hybrid) QMS

03:50 Comparing the Document Hierarchy

04:14 Centralized Document Structure

05:04 Decentralized Document Structure

05:22 Federated Standards, SOPs, and Governance

06:50 The QMS Tree: Philosophy, Governance, and Execution

08:20 Why Governance Matters More Than the Model

Subhi Saadeh is a quality professional, consultant, auditor, and trainer who specializes in drug-device combination products, medical devices, pharmaceutical quality systems, supplier quality, and lifecycle management. Through Let’s Combinate, he helps pharmaceutical and medical device teams bridge the gap between drug and device quality, regulatory expectations, and practical execution.

In this episode of Let’s Combinate: Drugs + Devices, Subhi Saadeh talks with Julia Anthony, founder and chief strategy officer of Solution Medical, about adrenal crisis, emergency hydrocortisone, and what it takes to build a drug-device combination product from a patient need.

Julia was born with salt-wasting congenital adrenal hyperplasia, a life-threatening form of adrenal insufficiency. Because her body cannot make cortisol, she takes cortisol replacement daily and may need an emergency hydrocortisone injection during a crisis.

The problem?

The current emergency injection can take upto 14 steps to prepare, mix, and administer.

Julia explains why the liquid and powder need to stay separate for stability, why the current process is so difficult during an emergency, and how Solution Medical is developing a proprietary dual-chamber primary container to simplify reconstitution while maintaining shelf life without refrigeration.

We also discuss how the company evolved from a device idea into a drug-led 505(b)(2) NDA program, the development of a four-step prefilled syringe and two-step auto-injector, human factors testing with both patients and injection-naive users, manufacturing challenges in aseptic processing, supplier trust, regulatory strategy, and the broader platform potential for other mix-before-inject drugs.

Chapters

00:00 Meet Julia Anthony

01:04 Living Without Cortisol

02:03 The 14-Step Injection

05:01 Building a Combination Product

07:54 From Device Concept to Pharma Company

10:06 Needles, Steps, and Testing

13:25 Patient Insights and Human Factors

16:58 Real-World Access Challenges

21:50 Why Not a Liquid Formulation?

24:15 Regulatory Pathway: 505(b)(2)

25:13 Manufacturing and Partner Trust

27:32 Rare Disease and Supplier Power

31:53 Platform Vision Beyond Adrenal Insufficiency

38:05 Reconstitution Is the Hard Part

41:12 COVID Tailwinds and Timeline

43:38 Where to Find Solution Medical

44:42 Final Thoughts on Cortisol

About Subhi

Subhi Saadeh is a consultant, trainer, and auditor focused on quality, regulatory, manufacturing, and supplier challenges for drugs, devices, and combination products.

Through Let’s Combinate, Subhi helps companies navigate the messy intersection of pharmaceutical and medical device requirements through consulting, training, audits, and practical education.

He also hosts Let’s Combinate: Drugs + Devices, where he speaks with leaders building, regulating, manufacturing, and improving combination products.

Download the free Drug vs. Device Quality comparison guide here: https://letscombinate.kit.com/216fbfc6c2

In this Let’s Combinate episode, Subhi explains why drug and device quality are not the same and highlights five key areas where they differ for combination products.

Drug quality often focuses on consistently remaking the product that was proven clinically, using critical quality attributes, specifications, analytical methods, stability, process validation, and batch release.

Device quality emphasizes design robustness and intended use through design controls and product realization, from user needs and design inputs to validation and design transfer.

This episode covers five major differences:

Quality philosophy and evidence

Development approach

Risk management

Regulatory submission focus

Lifecycle management and change control

The goal is not to force one system onto the other. The goal is to understand the differences early enough to intentionally integrate drug and device quality across development, manufacturing, regulatory strategy, and lifecycle management.

Chapters

00:00 Drugs vs. Devices: Why Quality Differs

00:20 Intro and Practical Guide

00:50 Quality Philosophy and Evidence

02:27 Development Approach Differences

03:56 Risk Management Mindsets

05:48 Regulatory Submission Focus

06:23 Lifecycle and Change Control

08:03 Summary and Next Steps

Subhi Saadeh is a quality professional, consultant, auditor, and trainer who specializes in drug-device combination products, medical devices, pharmaceutical quality systems, supplier quality, and lifecycle management. Through Let’s Combinate, he helps pharmaceutical and medical device teams bridge the gap between drug and device quality, regulatory expectations, and practical execution.

Chat with Subhi: https://calendly.com/letscombinate/let-s-combinate-intro-session

Finished medical devices can create a lot of surprises when they are added to combination product kits.

A needle, vial adapter, filter, or transfer device may already be sterile, cleared, qualified, and sold at massive scale.

But already on the market does not automatically mean ready for your combination product.

In this episode, I talk through the challenges of selecting finished medical devices for combination product kits and the three lifecycle moments that usually determine whether qualification goes smoothly or turns into a late-stage problem.

We cover:

* Why “already approved” does not mean combination-product ready

* Why you inherit the supplier’s design, QMS, packaging, validation, change control, and outsourcing decisions

* What to think about before supplier selection

* How to set expectations during supplier selection

* Why structured qualification matters

* How PPAP concepts like process flow, PFMEA, control plans, inspections, sampling, and validation evidence can help

The main point: A commercially available device may be qualified for someone else’s intended use. Your job is to determine whether it is qualified for yours.

Chapters:

00:00 Device Selection Stakes

02:05 Common Supplier Myths

03:54 Inheriting the Device QMS

04:53 Three Crucial Moments

05:51 Before Selection: Intended Use

07:21 Packaging, Markets, and Risk Flags

08:55 During Selection: Set Expectations

10:33 Qualification: Use a Structured PPAP Approach

14:12 Wrap Up and Next Steps

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, supplier quality, and regulatory expectations across drug and device domains. He is a consultant, auditor, trainer, and speaker with experience across companies including Pfizer, Gilead, and Baxter, supporting the development and launch of combination products across vaccines, biologics, and generics.

Let’s Combinate helps teams develop and control drug-device combination products by aligning quality systems, development, supplier quality, and regulatory expectations across drug and device domains.

#CombinationProducts #MedicalDevices #PharmaQuality #SupplierQuality #DrugDeviceCombinationProducts #PPAP #QualitySystems

One of the hardest parts of auditing is not knowing what to look for.It is deciding where to start. Do you trace a deviation? Walk the process? Focus on one department? Audit CAPA across the organization? Or pull on a thread that does not quite make sense?

In this video, Subhi walks through six audit strategies from the ASQ Certified Quality Auditor Body of Knowledge and explains how they apply in real-world pharma, biotech, and combination product audits.

The six strategies covered are:

1. Tracing

2. Process Approach

3. Process-Based Management

4. Department Method

5. Element Method

6. Discovery Method

These approaches are useful whether you are auditing a supplier, a manufacturing site, a testing laboratory, or a quality system that spans drug, device, and combination product responsibilities.

Need support with combination product quality, auditing, supplier quality, or quality system strategy?

Schedule a Let’s Combinate intro call:

https://calendly.com/letscombinate/let-s-combinate-intro-session

Learn more about Let’s Combinate:

https://letscombinate.com

Preparing for the CQA exam?

Check out the CQA Master Class here:

https://cqeacademy.teachable.com/p/the-cqa-master-class-course

Chapters:

00:00 Six Audit Strategies Overview

01:12 Tracing Method Explained

02:59 Process Approach Workflow

04:27 Process-Based Management

05:46 Department Method Deep Dive

06:27 Element Method Across the QMS

07:12 Discovery Method: Pull the Thread

08:55 Summary: Pros and Cons

11:31 Final Tips and Next Steps

Subhi 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.

#Pharma #Biotech #Quality #Auditing #QualityAudits #CQA #GMP #CombinationProducts #QualitySystems #ISO13485

In this final episode of the ICH Quality series, we walk through the most important concepts in ICH Q14 and how they fit into the broader ICH quality framework.

Rather than reviewing the guideline section by section, this episode focuses on the ideas that are most useful in practice:

Why does ICH Q14 start with the Analytical Target Profile (ATP)?

How is it different from ICH Q2?

How do you develop analytical procedures using a science- and risk-based approach?

And what does all of this have to do with ICH Q12 and lifecycle management?

One quick note: at the time of recording, ICH Q14 remains under public comment, so some details may evolve before the final version is adopted.

Chapters

00:00 – Intro and ICH Q14 vs. Q2

01:08 – The Analytical Target Profile (ATP)

04:16 – The Analytical Procedure Lifecycle

05:32 – Risk-Based Development and Enhanced Approaches

06:20 – Where ICH Q2 Fits: Validation

08:04 – Connecting Q14 to ICH Q12 and Lifecycle Management

09:22 – Closing the ICH Quality Series

In this episode, we cover:

• Why ICH Q14 exists

• The difference between ICH Q14 and ICH Q2

• What an Analytical Target Profile (ATP) is

• ATP examples and performance criteria

• Technology selection and fit-for-purpose methods

• The analytical procedure lifecycle

• Risk assessments and enhanced development approaches

• Multivariate experiments and DOE concepts

• Analytical procedure control strategies

• Validation and the role of ICH Q2

• Lifecycle management of analytical procedures

• The connection between ICH Q14 and ICH Q12

• Why understanding matters more than simply checking a box

If you've followed along through the ICH Quality series, one of the themes that keeps showing up is that quality isn't something you test into products at the end. Whether we're talking about Q8, Q9, Q10, Q12, or now Q14, the emphasis continues to shift toward building knowledge, understanding risk, and using that understanding throughout the lifecycle.

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, speaker, and host of the Let's Combinate podcast, with experience across companies including Pfizer, Gilead, and Baxter supporting vaccines, biologics, generics, and combination products.

📅 Schedule an intro session:

https://calendly.com/letscombinate/let-s-combinate-intro-session

🎙️ Let's Combinate Podcast:

https://www.letscombinate.com

#ICHQ14 #ICHQ2 #ICHQ12 #AnalyticalValidation #PharmaQuality #QualityByDesign #LifecycleManagement #DrugDevelopment #CombinationProducts

ICH Q13 explains how pharmaceutical companies can apply batch definition, traceability, control strategy, validation, release, and lifecycle management to continuous manufacturing of drug substances and drug products.Learn more:https://www.letscombinate.comSchedule a call:https://calendly.com/letscombinate/let-s-combinate-intro-sessionIn this episode, Subhi Saadeh explains ICH Q13 and the key concepts behind continuous manufacturing in pharmaceutical manufacturing.The core question behind ICH Q13 is simple:How do you apply traditional quality concepts like batch definition, traceability, control strategy, validation, release, and lifecycle management when the manufacturing process does not stop?This episode covers the major Q13 concepts, including the difference between batch and continuous manufacturing, how batches can be defined in continuous manufacturing, the three continuous manufacturing models described in the guideline, residence time distribution (RTD), disturbance handling, control strategy, validation, release, and lifecycle management.Subhi also discusses why batches still matter in continuous manufacturing. Even when a process operates as a continuous flow, batches remain essential for traceability, investigations, trending, stability programs, release decisions, and recalls.Key topics covered:• What ICH Q13 is and why it matters• Batch manufacturing versus continuous manufacturing• Why manufacturers still need batch definitions• Time-based, mass-based, and campaign-based batch definitions• The three continuous manufacturing models described in ICH Q13• Residence Time Distribution (RTD)• Why RTD matters for traceability and investigations• Disturbance impact assessment and material disposition• Control strategy considerations for startup, steady-state operation, and disturbances• The role of Process Analytical Technology (PAT)• Disturbance management using magnitude, duration, and frequency• Validation considerations for continuous manufacturing• Release strategies supported by process understanding and monitoring• Lifecycle management and risk-based change controlTimestamps:00:00 ICH Q13 Overview00:48 Why Batches Matter01:21 Batch vs. Continuous Manufacturing01:59 Defining Batches02:48 Three Continuous Manufacturing Models03:54 Residence Time Distribution (RTD)06:05 Control Strategy Basics07:19 Disturbance Handling08:19 Validation, Release, and Lifecycle Management10:16 Wrap-Up and Next StepsSource referenced in this episode:ICH Q13: Continuous Manufacturing of Drug Substances and Drug ProductsFinal version adopted 16 November 2022https://database.ich.org/sites/default/files/ICH_Q13_Step4_Guideline_2022_1116.pdfReferences to ICH Q13 guideline and are included for educational commentary and discussion.Questions or feedback?📧 [[email protected]](mailto:[email protected])🌐 https://www.letscombinate.comSubhi 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, manufacturing, and regulatory expectations across drug and device domains. He is a consultant, auditor, trainer, and speaker with experience across Pfizer, Gilead Sciences, and Baxter, supporting the development and launch of vaccines, biologics, generics, medical devices, and drug-device combination products.

In this episode, Subhi breaks down ICH Q12, the guideline focused on post-approval change management and pharmaceutical product lifecycle management.

The core question behind ICH Q12 is simple: once a product is approved, what is actually binding, what is supporting information, and how should future changes be managed?

This episode covers the major Q12 concepts, including reporting categories, Established Conditions, supporting information, Post-Approval Change Management Protocols, the Product Lifecycle Management document, and the role of the Pharmaceutical Quality System.

Subhi also discusses why Q12 matters for drug-device combination products, where lifecycle changes may involve CMC information, device constituent parts, functional performance characteristics, and the broader control strategy.

Key topics covered:

• Why post-approval change can become difficult after approval
• How ICH Q12 supports more predictable lifecycle management
• Reporting categories for post-approval CMC changes
• Established Conditions versus supporting information
• Examples of EC candidates, including CQAs, CPPs, material attributes, methods, sites, and process information
• Why overcommitting or undercommitting ECs creates lifecycle risk
• How PACMPs help companies plan future changes
• What belongs in the PLCM document
• How ICH Q12 applies to drug-device combination products
• Why a strong PQS is essential for making Q12 work

Timestamps:

00:00 Introduction to ICH Q12

00:46 Why post-approval change gets difficult

02:45 Reporting categories

03:14 Established Conditions vs supporting information

04:10 EC examples: CQAs, CPPs, methods, sites, and process information

05:32 Post-Approval Change Management Protocols

06:38 PLCM document

08:08 Drug-device combination product callout

10:11 PQS and change management

10:28 Closing thoughts

Questions or feedback? Email [email protected]

Source referenced in this episode: ICH Q12, Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management, Final version adopted 20 November 2019. Screenshots shown in this video are from the ICH Q12 guideline and are included for educational commentary. https://database.ich.org/sites/default/files/Q12_Guideline_Step4_2019_1119.pdf

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.