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Validity : 14th Apr'24 to 24th Apr'24
Validation of Complex Cell-Based Potency Methods
- Identification of pathways involved in activity
- Selection of potency-indicating method(s)
- Identifying the cell line
- Selecting the assay platform
- Method development
- Creation of MCB and WCB
- Consideration of orthogonal methods
- FDA/EMEA/USP Guidelines
- Selection and documentation of reference standard
- Timeline for method validation
- Annual updates
Overview of the webinar
- This webinar will address development and validation of complex cell-based methods some cell-based methods are multifaceted
- Will discuss the selection of the method and the cell line, correlating the method with the pharmaceutical activity,
- Will also discuss the need for orthogonal methods, and the timeline for method validation
Who should attend?
- Validation Scientists
- Regulatory Affairs
- QA and QC
- Laboratory Managers
- Assay Development Specialists
Why should you attend?
- This webinar will address development and validation of complex cell-based methods
- Included is a discussion of selection of the method and the cell line
- In addition attendees will receive some recommendations on addressing orthogonal methods that support the validation of the selected potency method
- Also, correlating the method with the pharmaceutical activity of the product will be addressed and the timeline for method validation will be discussed
- The number of variables that contribute to the final result increase the complexity of cell-based methods that are often difficult to control in a GxP laboratory
Faculty - Dr.Gwen Wise-Blackman
Gwen Wise-Blackman has 20 years of combined experience in Cell-Based Assays and Quality Systems. She has worked at DuPont Pharmaceuticals, Catalent Pharma Solutions (formerly Magellan Laboratories and Cardinal Health), Covance, and Salix Pharmaceuticals. Her focus has been in High-Throughput Screening, Cell-Based Assay Method Development and Validation, and Quality Assurance. Gwen has a Bachelor of Science degree in biology from M.I.T and a PhD in Pharmacology from UVa. She is a member of ASQ and AAPS.