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RA (Regulatory Assurance) Training (FDA) looking for resources

contigo123

Starting to get Involved
#1
Hello,
I've been working in quality but will start to have ownership of regulatory tasks. Does anyone have suggestions for getting up to speed on specifically US regulatory submissions, etc.? I know that experience is the best way to go, but I don't have a resource to learn from right now. Any books that are good? Or training courses? (online training courses specifically, but would prefer live instead of prerecorded, if possible)
Thank you!
 
Last edited:
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Watchcat

Trusted Information Resource
#4
I think CDRH Learn is the place to start.

I would also recommend Connecting with and following some folks on LinkedIn. Try Michelle Lott and Ethan Drower. Everyone is pretty focused on the MDR right now, but they post good information regularly and, once you start following them, you will get posts by other RA folks in your feed and can expand your network from there. Plus the EU is probably going to cave on the MDR again shortly, so hopefully everyone can turn back to FDA and other regulators for a bit.

The RAPS forum is a good place for Q&A, although the expert to newbie ratio is extremely high and the scope of topics is huge, from submissions to quality systems to risk management for every regulatory agency from FDA to Health Canada to EU (and now the new UK), to Australia to Taiwan to China to India to...well, you get the idea. I might suggest you work through CDRH Learn before you look at RAPS. It provides a very good foundation, and then you can go from there, wherever you decide you need to go.

PS If you have been in Quality for a long time and the FDA submissions are for premarket clearance, I will warn you that I don't think that's an very good idea. Very different mindsets. So fasten your seatbelt, and good luck to you!
 

contigo123

Starting to get Involved
#5
I think CDRH Learn is the place to start.

I would also recommend Connecting with and following some folks on LinkedIn. Try Michelle Lott and Ethan Drower. Everyone is pretty focused on the MDR right now, but they post good information regularly and, once you start following them, you will get posts by other RA folks in your feed and can expand your network from there. Plus the EU is probably going to cave on the MDR again shortly, so hopefully everyone can turn back to FDA and other regulators for a bit.

The RAPS forum is a good place for Q&A, although the expert to newbie ratio is extremely high and the scope of topics is huge, from submissions to quality systems to risk management for every regulatory agency from FDA to Health Canada to EU (and now the new UK), to Australia to Taiwan to China to India to...well, you get the idea. I might suggest you work through CDRH Learn before you look at RAPS. It provides a very good foundation, and then you can go from there, wherever you decide you need to go.

PS If you have been in Quality for a long time and the FDA submissions are for premarket clearance, I will warn you that I don't think that's an very good idea. Very different mindsets. So fasten your seatbelt, and good luck to you!

Thanks, that's helpful!
 
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