Sign up to save your podcasts
Or
Share Episode 54: Risk Management Tools and Techniques with Michael Tyo
Share to email
Share to Facebook
Share to X
Share to email
Share to Facebook
Share to X
Or
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 [email protected]
View all episodes
By SOLABS, Mandy Gervasio, Philippe Gaudreau, and Guests
5
44 ratings
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 [email protected]