This course goes into detail about the CQA risk assessment process which is derived from the strategies in A-Mab: A Case Study in Bioprocess Development, CMC Biotech Working Group Web ISPE and/or CASSS, Ver 2.1, pp 001-278, Oct 30, 2009.  These strategies have been updated and expanded to include best-practice Failure Mode and Effects Analysis (FMEA) techniques from the CEO of PVLMC.  These updates have been used in regulatory filings which gained approval, including multiple FDA breakthrough status filings.  eTraining run time is 1 hr 45 min for 89 slides.  pdf copy and eTraining certificate also included.
 
Highlights of this training include the following:
Understanding the QTPP.
Identifying potential CQAs (pCQAs).
Using risk assessment to differentiate final CQAs (fCQAs) from non-CQAs.
 
A CQA Risk Assessment eTool is available to guide and help execute a CQA determination risk assessment.  This eTool includes all the potential CQAs which are evaluated for a typical biologic product. Purchase of the eTool plus this eTraining includes a 50% reduction in the cost of the company eTraining license.