Instructor: Dr. Wise Blackman This Method Validation training in drug development process will provide guidance in setting appropriate specifications, determining if the assay is validatable, and monitoring progress during the validation. Why Should You Attend:
This webinar will address frequently observed issues and problems with method validations. Validated methods are required for Phase III of the drug development process. Moving methods from the development phase to the validated phase ready for sample analysis does not always occur without unforeseen issues arising. Differences in laboratories and analysts, as well as instrumentation can contribute to delays in validating methods.
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 judgment can lead to unnecessary delays and repeated work. Setting solid requirements for determining that methods are ready for validation is critical. Unambiguous documentation of the method is also key when new analysts or laboratories are included in cross-validations. The attendees will understand key concepts from practical examples that will address major issues encountered during method validation.
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 foundation of 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
Instructor Profile:
Dr. Wise-Blackman, is currently Principal Investigator, Immunochemistry, Covance Laboratories, Chantilly, VA. Dr. Wise-Blackman leads a matrix team that successfully develops, optimizes, validates, and performs PK, biomarker, and neutralizing antibody cell-based assays in a GLP environment. Previously, Dr. Wise-Blackman was Senior Manager, Cellular Technologies, at the Cardinal Health RTP-Bio site. for 9 years. Dr. Wise-Blackman lead a team that successfully developed, optimized, validated, and performed 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 GLP ELISA methods, GLP neutralizing antibody assays, and GMP bioassays to support release and stability testing of biotechnology products, 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. more
