Episode 54: Risk Management Tools and Techniques with Michael Tyo

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 discussion on risk management tools. They discuss the importance of a risk plan and a risk assessment SOP, plus the FDA's expectations regarding the use of risk assessment tools.

Key Takeaways:

01:11 Introducing Michael and his Background

02:31 Does the FDA have a clear expectation for the use of risk assessment tools?

06:13 The importance of a risk plan

09:20 Why companies must all have an SOP for risk assessment

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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