Let's Combinate - Pharma + Medical Devices with Subhi Saadeh8 Maj 2024

135 - Combination Products Mindset, MDUFA and Combination Products, FDA Hierarchy, Supplier Management, Surprises in Industry, and Culture with Tony Watson

On this episode, I was joined by Tony Watson, Vice President of Regulatory and Quality at Windgap Medical.

On this episode, Anthony discusses:

03:11 The Formation and Impact of the Office of Combination Products

04:16 Challenges and Changes in the Regulatory Landscape for Combination Products

07:53 Understanding FDA Titles and Organizational Structure

11:03 From FDA to Biogen: Transitioning to Industry and Building Medical Device Competency

16:41 Insights into FDA and Industry Dynamics: Conferences, Regulations, and Mindset Shifts

20:05 Combination Product Mindset in Large Organizations vs. Startups

21:54 Navigating Small Company Dynamics and Supply Chain Management

22:29 The Importance of a Combination Product Mindset

25:14 Challenges and Evolution of Combination Products

26:42 Global Perspectives on Combination Products

27:30 Digital Health: The New Frontier

35:02 Quality Culture and Open Communication

Anthony started his career as a naval officer on ships before transitioning to the civilian side of government. He served nearly 20 years at FDA as a reviewer, branch chief, and division director. In his time at FDA, he was one of the original regulatory policy-makers for combination products on the CDRH side. He has led the development of sevral guidance documents that are still in use more than 10 years after he left FDA. He has been active in industry advocay groups and standards efforts related to combination products for nearly 20 years. Since leaving FDA in 2013, Anthony has been developing and leading device and combination product teams in biotech, biopharma, and digital health companies from startups to global scale. He is presently the Vice President of Regulatory Affairs and Quality at Windgap Medical, a drug delivery device startup in Watertown, Massachusetts. He is also an adjunct professor at Northeastern University in the Regulatory Affairs Program and advises companies in the digital health field.

LinkedIn url: https://www.linkedin.com/in/anthony-w-77abaa3?utm_source=share&utm_campaign=share_via&utm_content=profile&utm_medium=android_app

Det här avsnittet är hämtat från ett öppet RSS-flöde och publiceras inte av Podme. Det kan innehålla reklam.

Avsnitt(267)

259 - The Career Lesson I Learned the Hard Way in Pharma

Career growth in pharma and medical devices takes technical knowledge, leadership, and the ability to earn your team’s trust. In this episode, Subhi Saadeh shares a lesson from leading a drug-device c...

19 Okt 5min

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

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

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

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

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

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)

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