Some cell-based methods are multifaceted. This webinar will address development and validation of complex cell-based methods. It will discuss the selection of the method and the cell line, correlating the method with the pharmaceutical activity, the need for orthogonal methods, and the timeline for method validation.
This webinar will address development and validation of complex cell-based methods. In addition attendees will receive some recommendations on addressing orthogonal methods that support the validation of the selected potency method. Included is a discussion of selection of the method and the cell line. Also, correlating the method with the pharmaceutical activity of the product will be addressed. Finally, the timeline for method validation will be discussed.
Why Should You Attend:
This training will bring those interested in the subject matter up to date with the current Validation of Complex Cell-Based Potency Methods. Some cell-based methods are multifaceted. 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.This webinar will address development and validation of complex cell-based methods. In addition attendees will receive some recommendations on addressing orthogonal methods that support the validation of the selected potency method. Included is a discussion of selection of the method and the cell line. Also, correlating the method with the pharmaceutical activity of the product will be addressed. Finally, the timeline for method validation will be discussed.
Learning Objectives:
- Correlation of method with activity
- Understanding requirements for complex, multi-stage methods
- Verification of critical materials
- Process monitoring
- Assessment of orthogonal methods
- Validation parameters
- Setting appropriate timelines
Areas Covered in the Webinar:
- 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
Who Will Benefit:
- Validation Scientists
- QA and QC
- Regulatory Affairs
- Laboratory Managers
- Assay Development Specialists working in biopharmaceuticals, pharmaceuticals, and natural products/botanicals
Course Provider
Gwen Wise Blackman,
