Not currently, but it is our goal for our next filings to better justify that certain CQAs, when controlled by an analytical procedure, are correctly covered.

Join Dr. Cyrille Chéry (UCB) to learn more about Critical Analytical Procedure Parameters and Risk Assessments.

Watch the On-Demand presentation now: https://bio-qc.com/critical-analytical-procedure-parameters-and-risk-assessments/  

Plus, don’t miss his expert insights during the panel discussion on Overcoming key challenges in understanding and implementing guideline ICH Q14 for Analytical Procedure Development.