Transitioning Complex Cell-Based Bioassays from the Non-Regulated Lab to the GMP Test Facility: Executing a Successful Transfer
Instructor:
Dr. Wise Blackman
Product ID: 701059
- Duration: 90 Min
Description
Parameters that must be addressed include documentation of the assay, transfer of knowledge surrounding the performance of the assay, the effect of defined small changes to the assay procedure, and specifics of new analyst training.
Transitioning complex cell-based bioassays betweeen laboratories often contributes to high variability and marked faliure of assays. Careful attention to specific details can enhance ruggedness in cell-based bioassays leading to greater percentage of assays meeting acceptance criteria and less down-time. Parameters that must be addressed include documentation of the assay, transfer of knowledge surrounding the performance of the assay, the effect of defined small changes to the assay procedure, and specifics of new analyst training.
Areas Covered in the seminar:
- Importance of documenting the entire method, defining how to train the analyst, determing when the assay is considered successfully transferred and when an analyst is trained to performt he assay.
- Monitoring the assay for ruggedness during early optimization through method transfer.
- Setting criteria for assay acceptance and new analyst training.
- Defining "proficient to perform" the assay and "proficient to train".
Who will benefit:
This webinar will provide guidance in developing assays that will meet specifications thus reducing OOS and OOT results:
- Science staff designing, validating and transferring new assays
- Managers certifying new analysts
- Laboratory managers designing assay transfer and validation
Dr. Wise-Blackman, is currently Senior Manager, Method Development and Validation, at the Catalent Pharma Solutions 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 1st Quarter FY08 and 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.
More Training By Experts
- Implementing Process Controls for Optimum Performance of Cell-Based Assays
- Method Development With the Intention of Minimizing OOS Results
- Validation Challenges for Bioassays
- Common Problems and Mistakes in Method Validation in drug development process
- Skilled and Trained for the GXP Environment: Training That Works
Refund Policy
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).
