Development and Validation of Bioassays

Summary

This 3-day course will focus on factors to be considered in the design, development, and validation of bioassays. The course introduces terminology and important statistical tools and best practices. Examples and case studies will be provided to help solidify understanding on the topics of design and development, robustness, validation, and post-validation. Relevant pharmacopeial and EUA regulations will be highlighted.

Learning Objectives

• Recognize applicable terminology
• Explain concepts of relative potency
• Understand the bioassay life cycle
• Recognize bioassay best practices
• Explain bioassay design and development:
  • Fitness for use/potential challenges
  • Screening and optimization
  • Data and assumptions, variance heterogeneity
  • Goodness for fit and measurement of uncertainty
  • Normality, transformation and weighting
  • Validity/assay/system/sample suitable criteria
  • Acceptance criteria
• Understand robustness (experimental design concepts)
• Explain bioassay validation and post-validation:
  • Identifying and measuring significant sources of error
  • Experimental design and acceptance criteria
  • Statistical considerations involved

Key Topics

• Introduction to Bioassays
• Guidance Documents on Bioassays
• Design & Development
• Robustness
• Validation & Post Validation
• Statistical Analysis Models
• Examples / Case Studies

Who should attend?

Bioassay Development Scientists, QA/QC Personnel, Stability Scientist, Statisticians, CMC Scientists, Assay development Scientists

Our online training experience includes

• Our client zone – a single source for all training materials as well as pre and post-training communication
• Live interactive format via the Zoom platform
• Direct interaction with the trainer
• Q&As, case studies, polls
• Revisit recorded sessions for 7 days
• Training in digital format
• Digital and LinkedIn certificates