Let's Combinate - Drugs + Devices

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....

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 de...

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 inspect...

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 quest...

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 evidenc...

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 t...

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 Cha...

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, span...

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-...

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 pa...

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 per...

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-fo...

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...

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, s...

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...

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,...

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...

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 i...

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 develo...

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 con...

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, Es...

In this episode, Subhi breaks down Q11 by focusing on three key sections: how the drug substance process is developed, where that process begins, and how it is controlled. He places Q11 in context with Q7 for API GMP, Q8 for pharmaceutical development, Q9 for quality risk management, and Q10 for the pharmaceutical quality system. The episode covers Section 3 on manufacturing process development, S...

Six Major Auditing Strategies: Tracing, Process, Department, Element, Process-Based Management, and Discovery Course Link: https://cqeacademy.teachable.com/p/the-cqa-master-class-course In this episode, Subhi explains why selecting the right auditing strategy matters when auditors have limited time, limited access, and a specific audit objective. He walks through six major strategies: tracing, pro...

his episode looks at where Q10 fits in the broader quality landscape, including its roots in ISO 9001, ISO 9004, and ISO 13485, while making the key distinction that Q10 is not a certifiable ISO-style standard. Instead, Q10 is designed to augment regional GMPs and provide a lifecycle model for managing pharmaceutical quality. Using the Annex 2 PQS diagram, Subhi walks through how Q10 applies acros...

ICH Q9 is one of the most referenced guidelines in pharma and one of the most misunderstood. In this video, I break down what Quality Risk Management (QRM) actually is, how the process works, and how it’s different from ISO 14971. We cover: What “risk” means in ICH Q9 (probability × severity) The full QRM process (initiation → assessment → control → communication → review) How to actually think th...