Mastery in mRNA Manufacturing - Online Course

    Mastery in mRNA Manufacturing: Navigating International Regulations & Best Practices

    15 – 17 October 2024, live online training

    Summary

    Discover the cutting-edge world of mRNA-based therapeutics for international markets. Led by industry leaders, this nine-session course is tailored to meet the unique needs and regulatory requirements of the US pharmaceutical landscape.

    Explore EU and FDA guidelines, pharmacopeia standards, and facility design specifics crucial for mRNA production worldwide. Gain practical insights into navigating complex regulatory frameworks and optimizing manufacturing processes for success in the US and international market. Specifically, EU guidelines are complex regarding mRNA technology, and they are used also worldwide.

    From sterile filling to packaging and transportation, learn the meticulous standards required to ensure product integrity and regulatory compliance. Dive deep into quality control protocols, testing standards, and modern process validation strategies.

    Join us to uncover crucial insights on cross-contamination control, supplier qualification, and in-process control strategies, essential for staying ahead in the dynamic world of mRNA manufacturing. Elevate your expertise and accelerate your success in the American pharmaceutical industry with this comprehensive course.

    Learning Objectives

    • Understanding of regulations and pharmacopeial standards relevant to mRNA-based therapeutics
    • Insight into facility design considerations specific to mRNA production, ensuring efficient and compliant manufacturing
    • Knowledge of sourcing raw materials and navigating US standards for drug substance and product manufacturing
    • Familiarity with sterile filling, packaging, and transportation protocols essential for maintaining product integrity
    • Mastery of quality control and testing procedures tailored to meet rigorous regulatory requirements
    • Adoption of modern process validation strategies aligned with US regulations to ensure product quality and safety
    • Implementation of effective cross-contamination control measures to maintain manufacturing integrity
    • Proficiency in supplier qualification methods and material release protocols for mRNA manufacturing
    • Understanding of in-process control strategies and sampling techniques crucial for maintaining process consistency and quality assurance
    • Awareness of the latest advancements and emerging trends in mRNA therapeutics, empowering attendees to contribute effectively to the rapidly evolving field

    Key Topics

    • Regulatory Frameworks: FDA and EU guidelines as well as pharmacopeia standards
    • Facility Design: Layout considerations for mRNA production
    • Manufacturing Processes: Sourcing raw materials and ensuring compliance with international standards
    • Sterile Filling and Packaging: Protocols for maintaining product integrity
    • Quality Control and Testing: Rigorous standards and analytical methods
    • Process Validation Strategies: Modern approaches
    • Cross-Contamination Control: Strategies to prevent contamination
    • Supplier Qualification: Modern methods for qualifying suppliers
    • In-Process Control Strategies: Implementing controls and sampling strategies

    Who should attend?

    • Professionals involved in the development, production, and regulation of mRNA-based therapeutics
    • Scientists and researchers specializing in nucleic acid therapeutics
    • Bioprocess engineers and biotechnologists interested in mRNA manufacturing
    • Quality assurance and control experts focusing on mRNA product testing and validation
    • Regulatory affairs specialists navigating the unique regulatory landscape of mRNA products
    • Supply chain managers handling materials and suppliers specific to mRNA production
    • Clinical researchers and medical professionals exploring the latest advancements in mRNA therapies
    • Investors and entrepreneurs seeking insights into the growing market of mRNA-based medicines
    • Educators and students looking to expand their knowledge of cutting-edge biopharmaceutical technologies, particularly mRNA therapeutics

    Past Participants

    • Senior Engineer, Mrna Process Development Process Development Prime Medicine, USA
    • Sr. Director, Recode Therapeutics, USA
    • Process Subject Matter Expert, Jacobs, USA
    • Engineer II, Technology Transfer, CSL Seqirus, USA
    • Research Advisor, Eli Lilly, USA
    • Director, Global MS&T, CSL Seqirus, USA
    • Research and Operations Associate, Project Manager, ARV Technologies, USA
    • Sr Specialist Supplier Quality, Moderna, Switzerland
    • Senior Scientist, Novavax, USA
    • mRNA Process Development Scientist, Thermofisher Scientific, Italy

    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 7 days
    • Training in digital format
    • Digital and LinkedIn certificates

    Trainers

    quality, biotech, biologics, regulatory
    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 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.
    Mastery in mRNA

    Mastery in mRNA Manufacturing

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

    Online Participation
    1 850  Price incl. VAT: 1 850 

    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
    • Start Date
      15. October 2024
      05:00 PM Vienna time
      04:00 PM London time
      11:00 AM New York time
      08:00 AM Los Angeles time
    • End Date
      17. October 2024
    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