Common Problems and Mistakes in Method Validation in drug development process
Instructor:
Dr. Wise Blackman
Product ID: 700267
Training Level: Intermediate to Advanced
- Duration: 60 Min
Validated methods are required for Phase III of the drug development process. Setting appropriate specifications and criteria based on solid data from development and qualification will contribute to successful completion of method validations. Key issues may be overlooked or not anticipated when methods are developed, optimized, and qualified that can lead to assay failures during validation. Rushing to judgement can lead to unecessary delays and repeated work.
Areas Covered in the seminar:
- Importance of defining the method and trending necessary information. Importance of setting appropriate specifications.
- Designing appropriate assays
- Establishing correct specifications
- Identifying an appropriate reference standard
- Building on the foundationof a good qualification
- Creating effective templates for validation studies
Who Will Benefit:
This webinar will provide guidance in setting appropriate specifications, determining if the assay is validatable, and monitoring progress during the validation.
- Laboratory personnel responsible for day-to-day functioning of laboratories
- Laboratory managers monitoring critical systems and reportable results
- Scientific staff involved in assay development, qualification, and/or validation
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.
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