quality requirements for biologics

    Quality Requirements for Biologics

    4 – 6 October 2023, live online training


    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 (CFR, FDA, EU-GMP guidelines), 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 7 days
    • Training in digital format
    • Digital and LinkedIn certificates


    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.

    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.

    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

    +421 222 200 543

    Training Details
    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

    "It was really good to have questions after each part."
    Director Analytical Development, Curevac

    "Very much enjoyed the regulatory section, the questions and discussions."
    Business Development Manager EU, Aspen

    "Thank you very much for the valuable presentations and training."
    Head of CMC Statistics, Novavax