This Validation training will provide guidance in overcoming inherent variability in bioassays.
Challenges that are frequently encountered are setting appropriate ranges for validation parameters, getting enough data for ruggedness and robustness, minimizing analyst and instrument variability, and performing the appropriate statistical analysis on the data.
Areas Covered in the Seminar:
- Optimization studies
- Ranges for Validation Parameters
- Ruggedness and Robustness Challenges
- Analyst and Instrument Variability
- Parallelism
Who Will Benefit:
This webinar will provide guidance in overcoming inherent variability in bioassays.
- Laboratory personnel responsible for day-to-day functioning of laboratories
- Laboratory managers monitoring critical systems and reportable results
- Science staff performing validation studies
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.
