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Episode 54: Risk Management Tools and Techniques with Michael Tyo
Manage episode 399578259 series 2364916
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
56 episodes
Manage episode 399578259 series 2364916
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
56 episodes
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