Let's Combinate - Pharma + Medical Devices with Subhi Saadeh1 Helmi 2023

070 - The First Auto-Injectors, ISO-11608 History, and Managing Product with Paul Jansen

On this episode, I was joined by Paul Jansen, who's a drug/device consultant, advisor, and board member in the combination products space. Paul discusses:

- His experience leading combination product focused organizations at Eli Lilly & Sanofi

- The first autoinjectors and the history surrounding ISO 11608

- Managing a product line, owning P&L and the product development mindset shift that came with that

Paul Jansen is currently working as a Drug Device Development Consultant. He is also on the Board of Directors at Subcuject and sits on the Advisory Boards of Evoleen, Windgap & Kymanox. He was formerly Associate Vice President, Medical Device Development, Sanofi until his retirement in January 2017. Paul has extensive experience in the design, development, manufacturing and lifecycle management of medical devices. Paul has multiple patents to his name and has deep experience in the creation and management of intellectual property portfolios. He has successfully led teams that have developed and launched several award winning devices, including Lantus SoloStar the world’s most popular insulin pen injection device. In addition, he has expertise in the design and development of injection molding systems and electronic components. Paul has been a long time member of the International Standards Organization serving as Working Group Convenor and Expert on many work groups responsible for standards related to injection devices. Until January 2022 he was the Chair of Technical Committee 84, Devices for the Administration of Medicinal Products and Catheters.

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258 - Combination Product Quality: Human Factors, CDMO Scorecards, ISO 14971 vs. ICH Q9, with Ben Locwin

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...

12 Loka 34min

257 - 21 CFR Part 4 Explained: CGMP Requirements for Combination Products

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 ...

5 Loka 12min

256 - The New FDA Inspection Playbook: Where to Start with QMSR

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...

28 Syys 9min

255 - Audit Interview Techniques: How Good Auditors Get Better Evidence

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 ...

21 Syys 11min

254 - Saying No Is the Easy Part of Quality

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 abs...

13 Syys 12min

253 - FDA Is Making Big Changes to Its Inspection Approach

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+ insp...

7 Syys 45min

252 - Acceptance Sampling Fundamentals: AQL, Attributes vs Variables, and Risk (OC Curves)

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 m...

31 Elo 13min

251 - The Future of Drug Delivery: Orals, Injectables, Sustainability & Device Strategy

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 del...

24 Elo 49min