Validation of Complex Cell-Based Potency Methods
Instructor:
Gwen Wise Blackman
Product ID: 705172
Training Level: Intermediate
- Duration: 60 Min
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
Gwen Wise Blackman
Manager, Salix Pharmaceuticals
Gwen Wise-Blackman, Ph.D., 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), and Salix Pharmaceuticals. She is currently Principal Consultant at Gwen Wise-Blackman Consulting. Her career 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.
Refund Policy
Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
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. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar 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).
