process validation scale-up biologics training

    Process Scale-up, Validation and Technology Transfer for Biologics

    5 – 7 December 2022, live 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.

    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

    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

    Past Participants

    • Senior Scientist, CGTT, Orchard Therapeutics
    • USP Manufacturing Technician, Alvotech
    • Head of Production, F. Hoffmann-la Roche
    • Technical Project Leader, Fujifilm
    • R&D Scientist, ProBioGen
    • DSP Process Transfer Lead, UCB
    • Director, Quality Assurance, Adverum Biotechnologies
    • Project Manager Validation Services, Sartorius
    • Senior Process Scientist, Bluerock Therapeutics
    • R&D Manager, MilliporeSigma
    • Process Engineer, Morphosys
    • Scientist Process Development, Novozymes

    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

    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 and has revolutionised availability of extractable data and change notification practices around single use systems facilitating uptake of these systems.

    Process Scale-up, Validation and Technology Transfer for Biologics

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

    Registrations 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.

    pharma learning leader

    Lydia Makori

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

    Training Details
    • Start Date
      5. December 2022
      08:30 AM Vienna time
      07:30 AM London time
      02:30 AM New York time
      11:30 PM Los Angeles time
    • End Date
      7. December 2022
    What participants said about this course

    "The case studies and real life examples really helped to put things into perspective."
    Portfolio Manager, GSK

    "Practical examples were extremely useful and well presented."
    Senior Development Specialist, Bioton

    "I found the case studies very helpful. Also, the slides content was very well thought through, so that the course was not just a read-out of the text, but they are still a valuable material to go back to."
    Senior Manufacturing Sciences Scientist, Thermo Fisher Scientific

    "The amount of things that I still need to understand. This course definitely triggered my motivation to learn more and more in this specific field."
    Senior Process Scientist, BlueRock Therapeutics