Implementing Process Controls for Optimum Performance of Cell-Based Assays


Instructor: Dr. Wise Blackman
Product ID: 700191

  • Duration: 60 Min
Guidance for developing, optimizing, validating and maintaining cells used for cell-based assays using control charts. Bioassays are defined as any biological assay that can be used to show that a product will perform its’ stated function. Due to the nature of bioassays they are inherently variable and require extra care to achieve consistent performance.
Last Recorded Date: May-2008


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Why Should You Attend:

Monitoring several parameters graphed in control charts can help laboratory personnel, laboratory managers, and QA maintain cell-based assays within specifications. Control charts can be used to manage excursions toward limits or recognize early trends resulting from changes in analysts, equipment, or specific reagents.

What Attendees will Learn:

  • The importance of cell-based potency assays
  • Specifics of assay performance
  • Defining the control chart
  • Identifying data to enter into the control chart
  • Monitoring the process
  • Establishing limits and defining actions and alerts

Who Will Benefit:

This web seminar will provide guidance in developing, optimizing, valdiating and maintaining cells used for cell-based assays. The use of control charts will be addressed as an important component for maintaining control of cell-based assays.

  • Laboratory personnel responsible for day-to-day functioning of cell culture laboratories
  • Quality system auditors and managers examining OOS and OOT data
  • Laboratory managers monitoring critical systems and reportable results
  • Science staff designing new cell-based assays

Instructor Profile:

Dr. Wise-Blackman, is currently Senior Manager, Cellular Technologies, at the Cardinal Health RTP-Bio site. Dr. Wise-Blackman leads a team that successfully develops, optimizes, validates, and performs cell-based assays for lot release and stability projects in a GxP environment She was the co-recipient of both the Customer Focus Award for 3rd Quarter FY2004 and the Presidents Award for FY2004. Her expertise is GMP bioassays to support release and stability testing of biotechnology products, GLP ELISA assay development and validation, Cell Based Screens, and Receptor Binding Assays. Dr. Wise-Blackman was previously employed at Dupont Pharmaceuticals for nine years, working in the cardiovascular pharmacology and high throughput screening departments. She received her Ph.D. in Pharmacology from the University of Virginia, Charlottesville, VA and her Bachelor of Science in Biology from the Massachusetts Institute of Technology, Cambridge, MA

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