Aseptic Fill & Finish for Biologics

    TBC 2022, online training

    Summary

    This training course provides an in-depth analysis of aseptic filling, one of the most challenging process steps in fill & finish of liquid formulated, biopharmaceutical drugs or lyophilized biopharmaceuticals. The training will offer real life examples and best practices for aseptic filling process management, qualification, validation & enviromental monitoring, plus digital networking time with industry peers.

    Who should attend?

    • Heads of production
    • Shift leads
    • QA reps or shop floor QA
    • Project managers
    • Operators in aseptic filling or visual control

    Learning Objectives

    • Three interactive workshops and group exercises
    • Learn what are the causes for contaminations in an aseptic filling process
    • Development of a fictive aseptic filling process (what technology is used, which equipment and assignment of the requirements?)
    • Let’s build an aseptic filling facility, what are the main areas to be considered?
    • How to set up a holistic aseptic filling concept?

    Key Topics

    • Aseptic filling process management
    • New requirements by EMA and Annex 1
    • Holistic concept, techniques, interfaces
    • Validation and re-validation of aseptic filling steps
    • Environmental Monitoring
    • Visual control
    • Failure investigation & Practical tips
    • Examples of FDA findings for contaminations in aseptic products

    Programme

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

    Trainers

    Independent Consultant, Former Head of Production (Sandoz)
    Dr. rer. nat. Dipl. Ing Ute Reichert has more than 20-year experience in the biopharmaceutical and pharmaceutical industry, the last years as Head of an aseptic fill and finish production in Sandoz.
    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