Method Development and Validation for Assays Supporting Testing of Biologics

Method Development and Validation for Assays Supporting Testing of Biologics is a seminar that covers topics such as:

  • Understanding the different requirements for small versus large molecules
  • Mapping appropriate timelines with decision points
  • Designing, developing, optimizing, and validating key methods
  • Potency methods, other release and stability methods
  • Preclinical and clinical methods
  • Use of DOE and statistical analysis
  • Handling of critical materials
  • Process monitoring concepts
  • Assessment of orthogonal methods
  • Assessing readiness for validation
  • Defining the validation protocol with real-time capture of data analysis
  • Maintaining quality through documentation

Method Development and Validation for Assays Supporting Testing of Biologics brings together:

  • Validation Scientists
  • QA/QC
  • Regulatory Affairs
  • Laboratory Managers
  • Assay Development Specialists
  • Statistician
  • CMC Titles
  • Bio Assay

Important

Please, check the official conference website for possible changes, before you make any traveling arrangements

Prices are for evaluation only.

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