In this OOS (Out of Specification) training guidance will be provided in developing assays that will meet specifications thus reducing OOS and OOT results.
Attention to parameters that may be difficult to control or require trending to insure appropriate values are consistently met is necessary during the early development phase. A good development plan will allow full investigation of these parameters.
What Attendees will Learn
- 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
Who Will Benefit:
- Importance of defining the method and trending necessary information
- Specifics of assay performance
- Using the control charts in method development
- Setting prelimnary specifications
Instructor Profile
Dr. Wise-Blackman is currently Senior Manager, Cellular Technologies, at the Cardinal Health RTP-Bio site. Dr. Wise-Blackman leads a team that successfully develops, optimizes, validates, and performs cell-based assays for lot release and stability projects in a GxP environment She was the co-recipient of both the Customer Focus Award for 3rd Quarter FY2004 and the Presidents Award for FY2004. Her expertise is GMP bioassays to support release and stability testing of biotechnology products, GLP ELISA assay development and validation, Cell Based Screens, and Receptor Binding Assays. Dr. Wise-Blackman was previously employed at Dupont Pharmaceuticals for nine years, working in the cardiovascular pharmacology and high throughput screening departments. She received her Ph.D. in Pharmacology from the University of Virginia, Charlottesville, VA and her Bachelor of Science in Biology from the Massachusetts Institute of Technology, Cambridge, MA
