I love risk, and FDA risk management is something I live in every single day. I think it’s really important to understand that when people talk about risk and FDA risk management, it’s not about the elimination of all risk. It’s almost impossible to eliminate all risk. We get out of bed each day, and as soon as we hit the floor, we experience risk.
Importance of FDA Risk Management
What is critically important for companies to do, is to understand the drivers of risk. Understand where risk flows from, and to manage that risk and prioritize that risk, such that some risk is really important to address, and we have managed it, controlled it, and mitigated it to the extent possible… and some risk is really, you know, just not all that important. That’s really important for a company to do, because no company has infinite resources.
So regardless of whether you’re talking about a regulatory submission, or you’re talking about building controls, or quality systems, or a new product introduction… you know, it’s all about risk. Telling that story of where the risk flows from, what are the characteristics, what’s the likelihood, the probability, and using good risk models to quantify that risk and create relative risks is really important for companies to get a handle on.
And, if they’re not good with FDA risk management, they need help to build those risk models such that they can explain both internally, to their own internal stakeholders and to the external parties, in particular the regulators, what is the risk considerations they should be looking at.
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