NC and Deviation approach - please help

[Jim Wynne]

What is the product and what is the standard you're trying to satisfy?

You answered one of the two questions I asked.

Sorry sir. We’ll make cell therapy products (cells) derived from patient's own (autologous) or other (allogeneic) immune cells.

I'll try one more time: What is the standard you're trying to satisfy?

 

[Seasides]

I'll try one more time: What is the standard you're trying to satisfy?

FDA, cGMP, and some extent 21 CFR 11

 

[Jim Wynne]

FDA, cGMP, and some extent 21 CFR 11

Thread moved to a more appropriate forum.