Description:
Bioassays are used to demonstrate that a biologic product performs per the stated function and potency. Typically, these methods are performed in living systems. Cell-based methods can have inherent variable due to the nature of living systems. Minimizing potential variability can be achieved through careful documentation and analysis of assay performance on control charts. Monitoring numerous parameters may assist laboratory scientists, laboratory managers, QC and QA personnel identify and manage trends that could lead to OOS/OOT results. Since the number of parameters evaluated is dependent on the cell-type, assay-type, and number of critical component or reagents, this webinar will provide a general overview of the topic as well as specific examples of successful monitoring of cell-based methods leading to reduced assay failures
Course Objective
- Understanding the variable nature of cell-based methods
- Understanding the critical characteristics of cell-based assays that may affect performance
- Defining critical reagents
- Defining parameters to monitor
- Setting intermediate performance controls
- Details of control charts
- Setting alert and action limits Learn the Four Basic Steps needed for compliance with the FCRA
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Course Outline
- Brief introduction to cell-based methods
- Specific areas that may introduce variability in cell-based methods
- Value of control charts
- Risk associated with lack of monitoring of cells and critical reagents
- Best practices for data entry on control charts
- Evaluation of control chart data
- Reporting structures
- Inclusion in written test method
- Training of analysts
Target Audience
This webinar will provide valuable assistance to all personnel in:
- Biopharmaceutical
- Pharmaceutical
- Dietary supplements
Speaker: Gwendolyn Wise-Blackman,
Gwen Wise-Blackman 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), Covance, and Salix Pharmaceuticals. Her 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.
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