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Episode 54: Risk Management Tools and Techniques with Michael Tyo

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Manage episode 399578259 series 2364916
Content provided by SOLABS, Mandy Gervasio, and Philippe Gaudreau. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by SOLABS, Mandy Gervasio, and Philippe Gaudreau or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://player.fm/legal.

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

  continue reading

56 episodes

Artwork
iconShare
 
Manage episode 399578259 series 2364916
Content provided by SOLABS, Mandy Gervasio, and Philippe Gaudreau. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by SOLABS, Mandy Gervasio, and Philippe Gaudreau or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://player.fm/legal.

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

  continue reading

56 episodes

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