3-Hour Virtual Seminar: Validation Challenges for Bioassays

Gwendolyn Wise-Blackman

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Validation of test methods is a critical requirement for the drug development process. Bioassays are used to support biologics in the drug development process and in post-market analytical support. Unlike analytical test methods for small molecules, bioassays have unique requirements due to the variable nature of some critical components. Although some variability may be inherent, careful attention to setting appropriate limits and to robust qualification of critical components enhances the likelihood of success during validation. This 3-hour webinar will address several parameters that are important for the successful validation of a bioassay. Included in this discussion are multiple challenges that often lead to rework and failure that if appropriately addressed during development should not become issues that hinder validation.

  • Why method development is critical for a good method validation
  • Use of DOE 
  • Challenges unique to bioassays  
  • Challenges in cell culture 
  • Handling critical reagents 
  • Identifying and managing analyst variability
  • Details of the written method
  • Defining the validation process
  • Data Analysis
  • Learning from failures
  • Timelines and Continuous Improvement

Topics covered include:

  • Process of method selection
  • Selection and certification of the reference standard 
  • Setting appropriate limits for reagents 
  • Reagent supply and sample handling
  • Pre-test of critical reagents 
  • Testing robustness/ruggedness/selectivity/specificity prior to validation Analyst training
  • Peer review of the test method
  • Statistical analysis
  • Validation protocol and templates 
  • Preplanning
  • Documentation of deviations and failures

  • Method development scientists (pharmaceuticals, biopharmaceuticals, dietary supplements)
  • Method validation scientists (pharmaceuticals, biopharmaceuticals, dietary supplements)
  • Quality control professionals (pharmaceuticals, biopharmaceuticals, dietary supplements)
  • Quality assurance professionals (pharmaceuticals, biopharmaceuticals, dietary supplements)
  • Manufacturing professionals (pharmaceuticals, biopharmaceuticals, dietary supplements)
  • Laboratory managers (pharmaceuticals, biopharmaceuticals, dietary supplements)
  • Auditors (pharmaceuticals, biopharmaceuticals, dietary supplements

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Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment

Recorded video

Recorded video session

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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