Viral Safety for Biologics

    8 – 10 November 2021, online training

    Summary

    This three-day training course provides an in-depth analysis of scientific and regulatory challenges connected to viral clearance evaluation and characterization studies. Topics from virus safety of raw materials to critical process parameters for virus removal and inactivation during the manufacturing of Biotherapeutics will be thoroughly covered.

    Who should attend?

    Process development, Downstream development, Downstream production managers and scientists, QA and QC managers and personnel, Regulatory affairs managers

    Learning Objectives

    • Select the correct model viruses for the clearance studies
    • Get insights of important regulatory guideline and requirements for market applications
    • Background of tests for the characterization of cell lines
    • Inactivate & remove viruses during downstream processes
    • Conduct a viral clearance study from study plan, interaction with CRO to final validation report
    • Select the correct down scale model for the different clearance steps
    • Prepare the validation studies into required regulatory documents

    Key Topics

    • Sources and types of virus contamination
    • Virus safety regulatory background
    • Techniques for virus inactivation and removal in the Downstream Process
    • Viral clearance studies for clinical trials material in EU and US
    • Virus clearance studies for market authorization
    • Evaluation and characterization of viral clearance procedures
    • Limitations of virus validation studies

    Programme

    • Training materials will be provided in digital form
    • All delegates will receive digital and LinkedIn certificates
    • Online  networking with industry peers

    Trainers

    Nothelfer Consulting, Downstream Processing & Viral Safety
    Franz Nothelfer is currently professional consultant for downstream processing and viral safety. Before his retirement in 2017, he was heading a position as associate director Protein Science at Boehringer Ingelheim Pharma GmbH & Co. KG.
    MorphoSys, Director / Deputy Head of Production
    Dr. Hans Rogl is a Biochemist by training and started his industry career as manager of a downstream process GMP production facility at Roche Diagnostics GmbH in Penzberg, Germany.
    Online Participation
    1 450 Price incl. VAT: 1 450

    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.

    Lydia Makori

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

    Training Details