173 - Shelley Amster on 45 Years Trailblazing: IUD’s, Breaking Barriers in IVF & Women's

173 - Shelley Amster on 45 Years Trailblazing: IUD’s, Breaking Barriers in IVF & Women's

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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 Shelley Amster, a trailblazer in reproductive health with over 45 years of experience.

Shelley shares her journey from being one of the first IVF lab directors in the U.S. to her role as an advisor at 3Daughters. They discuss the early days of IVF, overcoming career-related insecurities, and the challenges and advancements in fertility treatments. Shelley also talks about her experience in managing technical conferences and offers advice for early-career professionals. The conversation covers innovative technologies in women's health, particularly in IUD development and surgical advancements.00:00 Welcome to Let's Combinate00:13 Pioneering in Reproductive Health00:42 Early Challenges and Opportunities02:10 Breaking Barriers in IVF04:52 Career Reflections and Lessons06:40 Conference Planning Insights13:37 Overcoming Shyness and Networking19:11 Retirement and Career Advice26:21 Innovations in Women's Health30:26 Future Technologies and Closing ThoughtsShelley Amster is a trailblazer in reproductive medicine with over 45 years of experience, including being one of the first IVF lab directors in the United States. Currently an advisor at Three Daughters, she has dedicated her career to advancing fertility treatments, IUD development, and surgical innovations in women’s health. Shelley is also a seasoned conference organizer and mentor, sharing invaluable insights with early-career professionals in the field.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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Avsnitt(266)

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

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 Okt 34min

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

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 Okt 12min

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

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 Sep 9min

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

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 Sep 11min

254 - Saying No Is the Easy Part of Quality

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 Sep 12min

253 - FDA Is Making Big Changes to Its Inspection Approach

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 Sep 45min

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

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 Aug 13min

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

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 Aug 49min

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