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: [email protected]

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: [[email protected]](mailto:[email protected])

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

In this episode, Subhi Saadeh sits down with Steven Kaufman, Founder of Combination Product Solutions, Inc. and fractional Chief Commercial Officer at Portal Instruments, to discuss where the drug delivery device market is headed and what it takes for new technologies to actually make it to patients.

Steven brings more than 21 years of experience across drug delivery and combination products, spanning strategy, business development, commercialization, consulting, and executive leadership.

The conversation explores what makes a drug delivery device commercially successful in 2026, why pharma companies can be hesitant to adopt unproven technologies, and how device companies can differentiate in an increasingly crowded market. Steven also discusses the growth of larger-volume subcutaneous delivery, the tradeoffs between reusable and disposable devices, sustainability, primary container strategy, and the changing role of sales and business development in drug delivery.

Subhi and Steven also dig into oral GLP-1s and whether oral drugs could ultimately displace injectables. Steven explains why route of administration alone does not determine the better solution — efficacy, patient adherence, cost, usability, and the overall treatment experience all matter.

The episode closes with Steven looking ahead to 2035 and explaining why he believes sustainability will be one of the major forces shaping the next generation of drug delivery devices.

Timestamps

00:00 Introduction and Steven’s Drug Delivery “Bookshelf”

02:24 From Marketing to Drug Delivery Strategy

06:10 What Makes a Device Commercially Successful in 2026?

11:11 Is the Large-Volume Injection Market Getting Crowded?

14:28 The Chicken-and-Egg Problem With New Device Technologies

19:25 CDAs, Proprietary Information and Working With New Suppliers

22:31 How Do You Sell a Drug Delivery Device in 2026?

29:17 Why Drug Delivery Is Still “Sexy”

31:20 Oral Drugs, Adherence and the Mucinex Horse Pill

33:18 Reusable Devices and Human Factors

35:22 Sustainability as a Drug Delivery Market Force

39:32 Cartridge vs. Prefilled Syringe

43:57 If You Had to Bet on One Drug Delivery Trend Through 2035

46:55 IV Drugs and the Shift Toward Subcutaneous Delivery

49:15 Steven’s Book Recommendation: Make Your Bed

51:22 Where to Find Steven

Steven Kaufman Bio

Steven Kaufman is the Founder of Combination Product Solutions, Inc. and a drug delivery and combination product executive with more than 21 years of industry experience.

His career has spanned device strategy, commercialization, business development, consulting, executive leadership, and entrepreneurship. Steven has held senior roles across the drug delivery industry and today works with device companies, biotech and pharmaceutical organizations, and investors on commercialization, technology strategy, platform evaluation, and bringing new drug delivery technologies to market.

Steven also serves as fractional Chief Commercial Officer at Portal Instruments.

Connect with Steven

Website: Combination Product Solutions

Email: [email protected]

LinkedIn: Steven Kaufman on LinkedIn

Subhi Saadeh Bio

Subhi Saadeh is a Quality Professional and host of Let’s Combinate. With a background in Quality, Manufacturing Operations, and R&D, he has worked in large medical device and pharmaceutical organizations supporting the development and launch of hardware devices, disposable devices, and combination products for vaccines, generics, and biologics.

For questions, inquiries, consulting, or episode suggestions:

Website: Let’s Combinate

LinkedIn: Subhi Saadeh on LinkedIn

Email: [email protected]

After 250 straight weeks of publishing Let’s Combinate every Wednesday, I’m making a change.

Starting now, new episodes will go live Mondays at 5:00 AM CT.

To everyone who watches, listens, shares, or has been part of the journey: thank you. This podcast has been one of the most enriching things I’ve ever done.

See you Monday.

🌐 https://letscombinate.com

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

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

About Subhi Saadeh

Subhi Saadeh is a combination product quality and compliance professional, consultant, auditor, trainer, and host of Let’s Combinate: Drugs + Devices, where he explores the intersection of pharmaceutical and medical device quality.

PIC/S has issued its first major update to its qualification and validation recommendations in nearly 20 years. PI 006-4 replaces PI 006-3 from 2007 and brings the document much closer to how qualification and validation are approached today.

In this video, I walk through where PI 006-4 fits within the broader GMP framework, how it relates to EU Annex 15, and the sections I think are most worth paying attention to.

A few of the major themes include a much stronger emphasis on quality risk management and lifecycle thinking, more explicit expectations around statistics, sampling, variability, and process capability, a move away from treating three validation batches as a default answer, and clearer discussion of traditional validation, continuous process verification (CPV), hybrid approaches, and ongoing process verification (OPV).

The goal isn't to suggest that all of these concepts are brand new. Many have been developing across the industry for years. What is interesting is seeing how PIC/S has now pulled them together into an updated recommendation that reflects current qualification and validation thinking.

Chapters

00:00 Big Update Overview

01:02 Who PIC/S Serves

01:28 Annex 15 Relationship

02:12 Scope and Exclusions

02:39 Why Update Now

04:05 Four Key Changes

04:47 Risk and Lifecycle Shift

06:43 Statistics and Sampling

07:48 Rethinking the Three-Batch Rule

08:30 Ongoing Process Verification

09:11 Traditional, CPV and Hybrid Approaches

10:45 Key Takeaways

About Subhi

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.

Connect With Let’s Combinate

Website:
https://www.letscombinate.com

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

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

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

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

Documents Discussed

PIC/S PI 006-4 — Recommendations on Qualification and Validation (2026)
https://picscheme.org/docview/11277

PIC/S PI 006-3 — Validation Master Plan, IQ/OQ, Non-Sterile Process Validation & Cleaning Validation (2007)
https://picscheme.org/docview/3447

EMA / PIC/S Concept Paper — Revision of Annex 15: Qualification and Validation (2026)
https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-revision-guidelines-good-manufacturing-practice-medicinal-products-annex-15-qualification-validation_en.pdf

PIC/S Publications Page
https://picscheme.org/en/publications

Audits are not supposed to be gotchas, and they are not meant to evaluate one person’s work in isolation. A good audit looks at whether a system is suitable, effective, and adequate and where it may need to improve.

In this video, I share the lessons I learned as I moved from being audited and supporting audit rooms to conducting audits as a certified lead auditor:

1) Audit the system, not the person: The goal is to understand how the system operates, not to catch an individual making a mistake.

2) Look for patterns, not isolated errors: One typo is different from a recurring or systemic problem, unless the individual event is critical.

3) Scope the audit before you start: The objective, criteria, time, resources, and agenda need to align before the audit begins.

4) Technical expertise is not the same as audit skill: Auditing requires its own tools, tactics, strategies, interviewing skills, and qualification.

5) Lower the temperature to get better evidence: People communicate more clearly when the auditor reduces unnecessary anxiety, although assertiveness is sometimes necessary when information is being withheld.

Chapters

00:00 Audits Aren’t Gotchas

00:38 Audit the System, Not the Person

03:16 Look for Patterns, Not Isolated Mistakes

05:27 Set a Clear Audit Scope

08:21 Auditing Is Its Own Skill and Being Technical Helps

11:11 Lower the Temperature and Be a Human

About Subhi

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:

https://letscombinate.com/

[email protected]

Connect with Subhi on LinkedIn:

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

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.