bioassay

    Development and Validation of Bioassays

    27 February – 1 March 2023, live online training

    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 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
    • Explain bioassay design and development:
    • Data and assumptions, variance heterogeneity
    • Acceptance criteria
    • Understand robustness (experimental design concepts)
    • Explain bioassay validation and post-validation:
    • Identifying and measuring significant sources of error

    Key Topics

    • Introduction to 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 30 days
    • Training in digital format
    • Digital and LinkedIn certificates

    Trainers

    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.
    Bioassays

    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. 2 056 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

    Certificate

    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

    l.makori@symmetric.events
    +421 222 200 543

    Training Details
    • Start Date
      27. February 2023
      02:00 PM Vienna time
      01:00 PM London time
      08:00 AM New York time
      05:00 AM Los Angeles time
    • End Date
      1. March 2023