Let's Combinate - Pharma + Medical Devices with Subhi Saadeh19 Maalis 2025

180 - MIT Leadership Expert Reveals Management Secrets for Scientists!

🚀 Stay ahead in combination products, pharma, and medical devices 👉 https://www.letscombinate.com🎙️ Listen to more expert discussions on regulations, drug delivery, and quality 👉 https://www.letscombinate.com/Get expert insights on FDA regulations, risk management, quality systems, and the latest trends in drug-device combination products. In this episode of Let's Combinate, host Subhi Saadeh interviews Gwen Acton, author of Leadership for Scientists and Engineers. Acton, an MIT Ph.D. turned leadership coach, discusses her book's key topics, including effective hiring, delegation, transitioning from individual contributor to team manager, and managing different personalities. They delve into the challenge of balancing technical work and leadership, the importance of defining leadership, and practical tips for delegation. Acton emphasizes that leadership skills can be learned and provides strategies for managing team goals and career development.Amazon: https://www.amazon.com/Leadership-Scientists-Engineers-Transforming-Brilliant-ebook/dp/B0DYWCDVRV?ref_=ast_author_dpBarnes and Noble: https://www.barnesandnoble.com/w/leadership-for-scientists-and-engineers-gwen-acton/1147071445?ean=979899239330900:00 Introduction and Guest Overview01:56 Gwen Acton's Leadership Journey04:30 Defining Leadership08:18 Optimizing Group Output09:30 Challenges in Leadership Transition12:35 Leadership vs. Technical Skills13:05 Transitioning from Technical to Leadership Roles14:18 Challenges of Dual Roles15:42 The Art of Delegation16:53 Motivating Your Team21:21 Balancing Trust and Oversight24:58 Conclusion and Final ThoughtsDr. Gwen Acton is a leadership expert specializing in the biotech and pharmaceutical industries. With a PhD in biology from MIT and years of experience guiding scientists and technical professionals into leadership roles, she helps individuals transition from expert contributors to effective managers. As a sought-after speaker, consultant, and author, Gwen provides practical strategies for navigating the complexities of leadership in highly regulated, innovation-driven environments.Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

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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