# 210 - How AI Is Rewriting GMP: Smarter CAPA, PAT, DOE, and Continuous Yield

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2025-10-15
- Length: 22m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2025-10-15-210-how-ai-is-rewriting-gmp-smarter-capa-pat-doe-and-continuous-yield
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/210---How-AI-Is-Rewriting-GMP-Smarter-CAPA--PAT--DOE--and-Continuous-Yield-e39hbgk

## Summary

Ben Locwin, a Healthcare Executive and Quality SME, joins host Subhi Saadeh to discuss integrating AI into Good Manufacturing Practices (GMP) within pharmaceutical and medical device manufacturing. They explore current applications like AI-assisted CAPA and deviation management, while highlighting the regulatory challenges of algorithmic opacity in Process Analytical Technology (PAT) and continuous manufacturing. The conversation emphasizes the critical role of Design of Experiments (DOE) in training AI models and using yield calculations as an early warning system for process discrepancies in combination products.

## Chapters

- [0:06](https://hardwarepodcasts.com/podcast/lets-combinate/2025-10-15-210-how-ai-is-rewriting-gmp-smarter-capa-pat-doe-and-continuous-yield#t=6) Introduction: AI in GMP and Quality 4.0
- [0:46](https://hardwarepodcasts.com/podcast/lets-combinate/2025-10-15-210-how-ai-is-rewriting-gmp-smarter-capa-pat-doe-and-continuous-yield#t=46) Current Applications: AI in CAPA and Deviation Management
- [2:37](https://hardwarepodcasts.com/podcast/lets-combinate/2025-10-15-210-how-ai-is-rewriting-gmp-smarter-capa-pat-doe-and-continuous-yield#t=157) Validation Challenges: PAT and Algorithmic Opacity
- [9:49](https://hardwarepodcasts.com/podcast/lets-combinate/2025-10-15-210-how-ai-is-rewriting-gmp-smarter-capa-pat-doe-and-continuous-yield#t=589) Design of Experiments (DOE) and Process Optimization
- [13:27](https://hardwarepodcasts.com/podcast/lets-combinate/2025-10-15-210-how-ai-is-rewriting-gmp-smarter-capa-pat-doe-and-continuous-yield#t=807) Continuous Manufacturing and Real-Time Release
- [15:40](https://hardwarepodcasts.com/podcast/lets-combinate/2025-10-15-210-how-ai-is-rewriting-gmp-smarter-capa-pat-doe-and-continuous-yield#t=940) Yield Calculation as a Process Indicator

## Topics

- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)
- [Manufacturing partners & offshoring](https://hardwarepodcasts.com/topic/manufacturing-partners)
- [AI & machine learning](https://hardwarepodcasts.com/topic/ai-and-machine-learning)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)

## Most relevant to

large enterprises

## Mentioned

- FDA (other)
- PAT (tool)
- DOE (tool)
- NIR spectroscopy (tool)
- Excel (tool)

## Related episodes from other shows

- [How to Use Artificial Intelligence & Machine Learning to Produce Better, Smarter, Safer Devices](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-05-13-how-to-use-artificial-intelligence-machine-learning-to-produce-better-smarter-sa) (Global Medical Device Podcast)
- [#456: What You Don’t Know Can Hurt You: 483 Pitfalls and Regulatory Accountability](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-04-20-456-what-you-dont-know-can-hurt-you-483-pitfalls-and-regulatory-accountability) (Global Medical Device Podcast)
- [#460: FDA AI Regulations: Master the QA/RA Skills to Stay Ahead](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-05-18-460-fda-ai-regulations-master-the-qa-ra-skills-to-stay-ahead) (Global Medical Device Podcast)
- [What are the Top Compliance Issues Plaguing Medical Device Manufacturers?](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-11-10-what-are-the-top-compliance-issues-plaguing-medical-device-manufacturers) (Global Medical Device Podcast)
- [#459: The Purolea Warning Letter & Validating AI in Medical Devices - What FDA Actually Requires](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-05-11-459-the-purolea-warning-letter-validating-ai-in-medical-devices-what-fda-actuall) (Global Medical Device Podcast)

## Citing this page

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