Development and Validation of Bioassays

    18 – 20 March 2024, live online training


    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


    Steven Walfish
    Steven Walfish brings over 30 years of industrial expertise in the development and application of statistical methods for solving complex business issues. Steven has experience applying statistical methods to analytical method verification and validation and stability analysis.

    Development and Validation of Bioassays

    Download the full training agenda to reveal complete session details, training takeaways, case studies, daily schedule, special features and full trainer bio.

    Online Participation
    1 850  Price incl. VAT: 1 850 
    Equivalent of approx. 2 073 USD.
    The price calculation in USD is informative and might slightly differ from your bank exchange rate

    Price per delegate including:

    Online participation

    Online workbook & materials


    PC, microphone, camera, stable internet connection and the Zoom application.

    Yes, we will make every effort to ensure best possible interaction. You will see the slides, interact with the trainer and fellow participants. Questions and group exercises will be facilitated through the online meeting platform.

    Yes, you can transfer the registration to a colleague at any time.

    Yes, you may transfer your registration to a different event up to one month before the scheduled dates, provided the training fee has been paid in full.

    pharma learning leader

    Lydia Makori
    +421 222 200 543

    Training Details
    • Start Date
      18. March 2024
      01:30 PM Vienna time
      12:30 PM London time
      08:30 AM New York time
      05:30 AM Los Angeles time
    • End Date
      20. March 2024
    What participants said about this course

    "The content was excellent, the format appropriate especially for a diverse audience, backgrounds and applications."
    Analytical Development Scientist, Genhelix

    "I really appreciate the training, how it's organized, thanks for letting the possibility to ask question at each step."
    Director Analytical Development, Curevac

    "Loved day 3 and the additional conversation and slides to summary high level the context based on application."
    Pd Analytical Scientist, Spark Therapeutics

    "Awesome course! Thank you. I would recommend this for everyone working in bioassays as early in development as possible."
    QC Analyst, Oxford Biomedica Solutions

    "A complete review of Bioassay."
    Senior Scientist, Oxford Biomedica

    "Very much liked the break out sessions and also the questions from other participants."
    Research Associate, Xencor

    "Instructor was very knowledgeable and easy to follow."
    Associate Director, GSK

    "Thanks Steven. You gave us a huge amount of information to consider and incorporate."
    Senior Research Scientist, Sanofi

    "Thank you Steven and thank you to Symmetric, a very interesting training."
    Senior Scientist, Galapagos