Validation of Complex Cell-Based Potency Methods 2015

Topics

• Selection of potency-indicating method(s)
• Identification of pathways involved in activity
• Selecting the assay platform
• Identifying the cell line
• Creation of MCB and WCB
• Method development
• FDA/EMEA/USP Guidelines
• Consideration of orthogonal methods
• Timeline for method validation
• Selection and documentation of reference standard
• Annual updates

Who should Attend

Attendees from:

• QA, QC
• Validation Scientists
• Laboratory Managers
• Regulatory Affairs
• Assay Development Specialists