quality requirements for biologics

    Quality Requirements for Biologics

    14 – 16 November 2022, live online training

    Summary

    This 3-day online training is a deep dive into the world of Biologics. You will obtain detailed information about the manufacturing and quality characteristics and intensify your know-how about the complex regulatory landscape. Topics on regulatory framework, quality and GMP requirements, manufacturing of the drug substance & IMPs, process validation, managing process changes, analytical methods or the release specification vs IPC requirements will be covered by Dr Felix Kern, the Head of Manufacturing at Merck KGaA, Germany.

    Learning Objectives

    • Understand the regulatory landscape
    • Overview over GMP and quality requirements for the manufacture
    • Learn about the development and the requirements for manufacturing
    • Modern process validation concepts and biologics
    • How to implement effective process changes
    • Implementation of analytical methods for biologics and requirements
    • Release specification compared to in-process control requirements

    Key Topics

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

    Who should attend?

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

    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
    Head of Manufacturing
    Dr. Felix Tobias Kern is Head of Manufacturing 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.
    quality requirements for biologics

    Quality Requirements for Biologics

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

    Online Participation
    1 650  Price incl. VAT: 1 650 
    Equivalent of approx. 1 777 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
    • Start Date
      14. November 2022
      01:30 PM Vienna time
      12:30 PM London time
      07:30 AM New York time
      04:30 AM Los Angeles time
    • End Date
      16. November 2022
    What participants said about this course

    "The trainer and the interactivity is brilliant."
    Head of Production, Recipharm Pharmaceutical Development

    "Accumulation of most relevant information, guidances and regulations for the daily interference with production of biologicals."
    CMC Specialis, Lundbeck

    "The interactive nature with many questions for the group was great. I felt this really picked out Felix's expertise."
    Principal Scientist, Catalent Pharma Solutions

    "Really enjoyed the many real cases."
    Head of Quality, Jafral

    "Very clean/lean presentation with a nice logical order for the topics."
    Quality Director, Polpharma Biologics