Process Scale-up, Validation and Technology Transfer for Biologics

    22 – 24 November 2021, online training

    Summary

    This 3-day online training is a deep dive into the world of state-of-the-art process scale-up and technology transfer of biologics. You will obtain crucial tools for designing quality into processes and managing the complex regulatory landscape.

    Who should attend?

    • Pharmaceutical Technologists
    • Bioprocess Scale up Scientists
    • Bioprocess Engineers
    • Process Scientists and Process Engineers
    • Process Validation Specialists
    • Technology Transfer Specialists
    • Manufacturing Management
    • Regulatory Affairs Managers
    • Quality Assurance Managers
    • Manufacturing Project Management
    • CMO Managers

    Learning Objectives

    • Understand the regulatory landscape for process validation & technology transfer
    • Apply QbD principles to scale-up, validation & technology transfer of biologics
    • Learn from proven best practices for scale-up of biologics manufacturing processes
    • How to work with and manage suppliers
    • Theory vs. practice and overcoming regulatory challenges

    Key Topics

    • Scale-up of bioprocesses
    • QbD principles during process development & scale-up
    • Process validation & managing regulatory changes
    • Process risk assessment
    • Continued process verification
    • Process performance qualification
    • Technology transfer – regulatory, planning & execution

    Programme

    • Training materials will be provided in digital form
    • All delegates will receive digital and LinkedIn certificates

    Trainers

    Managing Partner, BioFrey
    Dr. Denby is a Biochemical Engineer. Over the years he has worked at AstraZeneca, Oxford BioMedica and Becton, Dickinson and Company. In 2017 he founded BioFrey in 2017 and has revolutionised availability of extractable data and change notification practices around single use systems facilitating uptake of these systems.
    Registration Closed

    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.

    Lydia Makori

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

    Training Details