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

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 can be leveraged as a source of information on the FDA's current areas of focus and how monitoring them can help avoid the FDA's attention.

Key Takeaways

01:04: Michael introduces himself and his background

02:21: How can companies use warning letters as a source of information on the FDA's current area of focus

04:31: Michael shares a statistical analysis he conducted on warning letters in 2023

08:52: How warning letters give you an idea of what happened at the company

12:31: Understanding warning letters helps companies avoid the FDA's attention

Contact us at solabs-podcast@solabs.com

Avsnitt(63)

Episode 63 - Qualification of Software Vendors with Masha Ivankovic

Episode 63 - Qualification of Software Vendors with Masha Ivankovic

Welcome to Automating Quality, the life sciences–focused show that bridges the gap between automation and quality management. In this episode, our host Philippe welcomes Masha Ivankovic, President and...

18 Nov 202516min

Episode 62: Leveraging Internal Audits with Jim Ferguson

Episode 62: Leveraging Internal Audits with Jim Ferguson

Welcome to Automating Quality, the life sciences–focused show that bridges the gap between automation and quality management. In today's episode, our host Philippe welcomes Jim Ferguson, President and...

19 Aug 202523min

Episode 61: Value Added Quality with Ed Siurek

Episode 61: Value Added Quality with Ed Siurek

Welcome to Automating Quality, the life sciences–focused show that bridges the gap between automation and quality management. In today's episode, Ed and Philippe explore how quality can bring added va...

5 Juni 202527min

Episode 60: Investigative Methods with Michael Tyo

Episode 60: Investigative Methods with Michael Tyo

Welcome to Automating Quality, the life sciences-centric show that bridges the gap between automation and quality management. In today's episode, Michael and Philippe discuss investigation methods, ho...

5 Nov 202418min

Episode 59: Introduction to Investigations with Michael Tyo

Episode 59: Introduction to Investigations with Michael Tyo

Automating Quality Episode 59 – Inspection Readiness with Michael Tyo Welcome to Automating Quality, the Life sciences-centric show that bridges the gap between automation and quality. In today's ep...

1 Okt 202418min

Episode 58: Discovering AIBOM and the Future of SBOM with Joseph Silvia

Episode 58: Discovering AIBOM and the Future of SBOM 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 second in a two-part series discussing the Sof...

6 Aug 202415min

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

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 Soft...

9 Juli 202416min

Episode 56: Tips and Tricks for Maintaining Inspection Readiness with Caroline Guay-Adam

Episode 56: Tips and Tricks for Maintaining Inspection Readiness with Caroline Guay-Adam

Welcome to Automating Quality, the Life Sciences centric show that bridges the gap between automation and quality management systems. This episode is the second in a series on Inspection Readiness fea...

4 Juni 202418min

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