Training on FDA "Establishment Registration"

[SGquality]

Does any one know if there are training courses available on FDA's "Establishment Registration" ?

 

[Stijloor]

A Quick Bump!

Can someone help?

Thank you very much!!

 

[Ronen E]

Does any one know if there are training courses available on FDA's "Establishment Registration" ?

Hi,

I assume you are looking for training as a result of the 2012 changes.

I'm not aware of any such course or a cohesive set of training / guidance materials. My general feeling is that even the FDA is not yet 100% coherent about it, and the practice is being fine tuned and slowly improved as we speak.

You might be interested in the following:
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/ucm314844.htm
http://www.fda.gov/MedicalDevices/D...urDevice/RegistrationandListing/ucm053185.htm

The educational materials under
http://www.fda.gov/Training/CDRHLearn/ucm162015.htm#reglist
Don't seem to be too updated.

Cheers,
Ronen.