Viral Safety for Biologics online training course for pharmaceutical professionals

        Viral Safety for Biologics

        TBC, live online training

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        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.

        Learning Objectives

        • Select the correct model viruses for the clearance studies
        • Get insights into important regulatory guidelines 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 the 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

        Who should attend?

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

        Past participants

        • Senior Process Development Scientist, Merck
        • QC Product Coordinator Live Viral Vaccines, GSK
        • MSAT Process Scientist, Lonza
        • Development Team Lead, AGC Biologics
        • Associate Scientist, Amgen
        • USP Cell Culture Plant Team Leader, Polpharma Biologics

        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
        • Digital and LinkedIn certificates

        Trainers

        Franz Nothelfer
        Franz Nothelfer is currently a 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.
        Dr. Hans Rogl
        Dr. Hans Rogl is a Biochemist by training and started his industry career as a manager of a downstream process GMP production facility at Roche Diagnostics GmbH in Penzberg, Germany.

        Viral Safety for Biologics

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

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        Online Participation
        1 850 € Price incl. VAT: 1 850 €
        Equivalent of approx. 2 018 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
        Request in-house
        What participants said about this course

        "A very good training!"
        QC Manager, Praha Vaccines

        "Good meeting for not experts and also for well-trained participants."
        Scientific Director for the Healthcare Business, Biomerieux

        "A very good workshop including a lot of practical experience!"
        Head of Downstream Processing, Polymun

        "I have received a lot of knowledge that will be of big use for my profession."
        Quality manager, Vironova AB

        "I appreciate the atmosphere, the availibility of tutor, the interactions tutors and with other participants."
        Test Facility Director, Kendrion

        "The training has given me a broad overview challenges of viral studies and validation procedures to be applied."
        Biosafety Officer, University of Namur

        "The training was really well organized and the topics covered a large part of the virus safety field."
        Scientist in Biotech Process Development, Merck

        "A good training about viral safety. I will recommend this to my colleagues."
        Technicienne DSP Process Development, Merck

        "Every question that was asked in the chat was anwered promply and in details. The trainers were very friendly."
        MSAT Senior Scientist, Sanofi

        "Training is well performed and very informative."
        Expert Science & Technology, Novartis

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