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
Podden och tillhörande omslagsbild på den här sidan tillhör SOLABS, Mandy Gervasio, Philippe Gaudreau, and Guests. Innehållet i podden är skapat av SOLABS, Mandy Gervasio, Philippe Gaudreau, and Guests och inte av, eller tillsammans med, Poddtoppen.
