Validation of Complex Cell- Based Potency Methods

Duration: 60 Minutes
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. The areas covered in this presentation include:
Complex Cell Based Methods Validation
Product ID: 500888

  • 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
Why Should you Attend:
Quality professionals and laboratory professionals who are faced with validating a complex method for a novel product should attend this webinar to gain insights into navigating multifaceted methods. In addition attendees will receive some insights into orthogonal methods that support the validation of the selected potency method.

Objectives of the Presentation:
The objectives of the presentation include:
  • Correlation of method with activity
  • Understanding requirements for complex, multi-stage methods
  • Verification of critical materials
  • Process monitoring
  • Assessment of orthogonal methods
  • Validation parameters
  • Timelines
Who can Benefit:
  • Validation Scientists
  • QA, QC
  • Regulatory Affairs
  • Laboratory Managers
  • Assay Development Specialists
$375
Recorded Session for one participant
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Minimum 10 attendees
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  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Gwendolyn Wise-Blackman is a successful scientist/manager with increasing accountability for scientific expertise and budget in the pharmaceutical industry, including managing multiple projects. She has working knowledge of FDA/ICH GLP and GMP guidelines and has proven experience with cell-based potency assays, Cell-based neutralization assays, PK and immunogenicity ELISA used to support bioprocess techniques for large molecule therapeutics. Ms. Wise-Blackman also holds Research & Development expertise in High Throughput Screening, 7-transmembrane receptor binding assays, cell-based assays, cell culture, and ELISA. Ms. Wise-Blackman is gifted with excellent presentation skills as evidenced by numerous scientific speaking engagements and working knowledge of PMP principles. She was an invited lecturer for IBC and IVT conferences, 1999-2008.
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