In our most recent webinar, Heather Purvis was joined by Federico Rodriguez Quezada, a regulatory giant in the cell therapy field!
She got to ask him some burning questions about quality management across cell therapy workflows and the standards needed to ensure patient safety.
Question 1 was all about regulatory challenges:
“I think of the most challenging is two new guidances that came up this year… because these institutions out there, they’re trying to comply with these recommendations. Sometimes they have a lot of trouble because they don’t have a structure or mechanism to keep up with the changes. You know, the FDA is giving all these guidances and regulations. They tell you what to do, but not tell you how to do it.”
There’s a whole lot more insight from Federico in the on-demand webinar. What it here.
