Validation of Complex Cell-Based Potency Methods 2015 is a webinar that covers topics such as:
- 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
Validation of Complex Cell-Based Potency Methods 2015 is intended for attendees from:
- QA, QC
- Validation Scientists
- Laboratory Managers
- Regulatory Affairs
- Assay Development Specialists
