mRNA

        Manufacturing of mRNA-Based Therapeutics

        New Dates TBC 2023, live online training

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        Summary

        This 3-day online training is a deep dive into the world of messenger ribonucleic acid (mRNA). You will obtain detailed information about the manufacturing and quality characteristics and intensify your know-how about the process of scaling up and the transfer of know-how from the development stage to the market manufacturing stage.

        Learning Objectives

        • Understand the regulatory landscape
        • Overview over GMP and quality requirements for the manufacture of mRNA medicinal products
        • Learn about development and the basic requirements for manufacturing
        • How to manage facilities, utilities and equipment?
        • Modern cross contamination prevention concepts
        • Modern process validation concepts
        • How to implement effective process changes?
        • Implementation of analytical methods
        • How to implement a good In-Process Control concept?
        • Tech transfer from the development to the market manufacturing department

        Key Topics

        • Regulatory framework
        • Quality & GMP requirements
        • Manufacturing of the drug substance
        • Sterile filling
        • Process validation
        • Managing process changes
        • Analytical methods
        • Release specification vs IPC requirements

        Who should attend?

        Quality Assurance and Quality Control Manager, Regulatory Affairs Manager, Process Validation Specialist, Manufacturing Management, Process Development, Research and Development

        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

        quality, biotech, biologics, regulatory
        Dr. Felix Kern
        Dr. Felix Tobias Kern is the Associate Director - Head of Compliance Launch and Technology Center at the Merck KGaA in Darmstadt (Germany). He studied pharmacy in Mainz (Germany) and graduated at the Ludwig-Maximilians-University in Munich (Germany). He is an expert pharmacist for pharmaceutical analytics and pharmaceutical technology.
        Fritz Roder
        Fritz Röder
        Fritz Röder is Director Engineering at Merck KGaA in Germany and is a recognized expert in the pharmaceutical industry. He has large experience in pharmaceutical media supply, GMP environments and the processing of solid, semisolid and liquid (sterile) dosage forms.
        mRNA

        Manufacturing of mRNA-Based Therapeutics

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

        See the full training agenda
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        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

        "Really enjoyed the live Q&A section. Thank you."
        R&D Scientist, Phion Therapeutics

        "The discussion opened by questions from the participants was really great."
        VP CMC, Splisense

        "The examples for area design and the discussions were really interesting."
        Technical Leader, Chiesi Farmaceutici

        "Thank you for this training. The lively Q&A session has been well organised and I've learned a lot from the trainers, as well as the other participants during this session."
        Scientist Analytics, Axolabs

        "The training was very interactive, maximising the advantages of digital formats. The trainers were highly organised and open, backing each other up when needed. If the agenda was busy, it was well followed up."
        R&D Leader, Thermofisher Scientific

        "It was an enjoyable dive into the world of mRNA manufacturing process."
        Drug Substance Process Development Expert, Sanofi

        "Useful & efficient training. Very well organised."
        R&D Director, Syvento

        "It was really nice and interesting :)"
        Formulation Team Leader, Enesi Pharma

        "Q&A via live chat is very good."
        CMC Manager, Ziphius Vaccines

        "Coming from academic side of things and breaking into more industry related areas, this training is very interesting and insightful."
        Project Manager, Swiss Vaccines Institute for Pandemic & Biosecurity

        "Thanks for the great insight."
        C & GT Process Engineer, Celonic

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