Automating Quality9 Heinä 2024

Episode 57: Introduction to the Software Bill of Materials with Joseph Silvia

Welcome to Automating Quality, the life sciences-centric show that bridges the gap between automation and quality management systems. This episode is the first in a two-part series discussing the Software Bill of Materials (SBOM) with guest Joseph Silvia. We explore the history of SBOM, its current importance for the FDA, and how to ensure you have an SBOM in place when implementing or developing medical devices.

"Joseph is the CEO of MedWareCyber, a consulting firm specializing in FDA readiness, cybersecurity, and software readiness for the medical devices industry. He is extremely knowledgeable about the regulatory landscape, and we frequently refer to him for his regulatory expertise.

Key Takeaways

01:10 Introducing today's guest: Joseph Silvia

02:35 What is an SBOM?

04:24 What is the history of SBOM?

05:50 Now, the government is getting involved and SBOM is picking up steam.

06;35 What is the FDA's expectation on this topic for the medical devices industry?

09:03 When implementing or developing a device, how do you ensure that you have an SBOM in place to support it?

11:38 Who is responsible for SBOM within organizations?

14:37 Where can listeners learn more about this topic?

Reach Joseph at jsilvia@medwarecyber.com

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Jaksot(63)

Episode 55: Inspection Readiness Strategies with Caroline Guay-Adam

Welcome to Automating Quality, the Life Sciences centric show that bridges the gap between automation and quality management systems. In this episode, we discuss a topic key to the heart of most quali...

7 Touko 202415min

Episode 54: Risk Management Tools and Techniques with Michael Tyo

Welcome to Automating Quality, the Life Sciences centric show that bridges the gap between automation and quality management systems. In this episode, guest Michael Tyo joins Philippe Gaudreau in a di...

6 Helmi 202415min

Episode 53: Leveraging the FDA's Warning Letters with Michael Tyo

Welcome to Automating Quality, the Life Sciences centric show that bridges the gap between automation and quality management systems. In this episode, guest Michael Tyo discusses how warning letters c...

9 Tammi 202418min

Episode 52: Supplier Quality Management w. Mandy Gervasio

Welcome to Automating Quality, the Life Sciences centric show that bridges the gap between automation and quality management systems. This show is hosted by Philippe Gaudreau, CEO at SOLABS, and Mand...

28 Marras 202317min

Episode 51: Takeaways from 2023 Quality Conferences with Mandy Gervasio

17 Loka 202320min

Episode 50: Analytics for GMP Floor Environment with Jamie Villeneuve

Welcome to Automating Quality, the Life Sciences centric show that bridges the gap between automation and quality management systems. Philippe Gaudreau, CEO at SOLABS is your host for this very specia...

1 Elo 202316min

Episode 49: Designing Analytics for the Life Sciences Industry with Jamie Villeneuve

4 Heinä 202316min

Episode 48 - Supplier Management Quality for the Medical Devices Industry with Joseph Silvia

2 Touko 202314min

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