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Validation of Complex Cell- Based Potency Methods Webinar  

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Seminar Summary:

Acquire knowledge on complex cell-based methods, selection of the method and the cell line, and correlating the method with the pharmaceutical activity. (see full course description)

 

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Training Course Syllabus:


Validation of Complex Cell- Based Potency Methods Webinar

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:


  • 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

Seminar Summary:

Acquire knowledge on complex cell-based methods, selection of the method and the cell line, and correlating the method with the pharmaceutical activity. (see full course description)

print this agenda print agenda for the Validation of Complex Cell- Based Potency Methods Webinar training seminar

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