Guidance for developing, optimizing, validating and maintaining cells used for cell-based assays using control charts.Description
Bioassays are defined as any biological assay that can be used to show that a product will perform its’ stated function. Due to the nature of bioassays they are inherently variable and require extra care to achieve consistent performance.
Monitoring several parameters graphed in control charts can help laboratory personnel, laboratory managers, and QA maintain cell-based assays within specifications.
Control charts can be used to manage excursions toward limits or recognize early trends resulting from changes in analysts, equipment, or specific reagents.You Will Learn:
Who Will Benefit:
- The importance of cell-based potency assays
- Specifics of assay performance
- Defining the control chart
- Identifying data to enter into the control chart
- Monitoring the process
- Establishing limits and defining actions and alerts
This web seminar will provide guidance in developing, optimizing, valdiating and maintaining cells used for cell-based assays. The use of control charts will be addressed as an important component for maintaining control of cell-based assays.
- Laboratory personnel responsible for day-to-day functioning of cell culture laboratories
- Quality system auditors and managers examining OOS and OOT data
- Laboratory managers monitoring critical systems and reportable results
- Science staff designing new cell-based assays