Let's Combinate - Drugs + Devices

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

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: info@combinationproductsolutions.com
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: subhi@letscombinate.com

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/
subhi@letscombinate.com

Connect with Subhi on LinkedIn:
https://www.linkedin.com/in/subhi-saadeh-1169aa21