process and equipment change

    Process and Equipment Change Management

    19 – 21 June 2023, live online training


    Changes of equipments and manufacturing processes, but also of analytical processes are on top of the agenda in the world of digitalization. These quality systems are time and material consuming, so there is a need for the implementation of smart management strategies. In this 3 day course the basics of the management of significant equipment and process changes is presented and discussed, as well as the regulatory background behind such changes.

    Learning Objectives

    • Implementation of correct management of significant changes of equipments
    • Learn about the management of significant changes of manufacturing and analytical processes
    • Understand the regulatory requirements behind the changes
    • What are the systems linked to the change management?
    • Practical Case Studies
    • Big Workshop
    • Interactive discussions with colleagues from different pharmaceutical areas

    Key Topics

    • Smart management of equipment changes and smart qualification strategies
    • Smart management of process changes and smart revalidation strategies
    • Regulatory background behind such changes
    • Deviation, risk and audit management
    • Case Studies for significant changes and follow-ups
    • Workshop with an example directly from practice

    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


    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.
    process and equipment change

    Process and Equipment Change Management

    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 
    Equivalent of approx. 2 056 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


    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
    • Start Date
      19. June 2023
      01:30 PM Vienna time
      12:30 PM London time
      07:30 AM New York time
      04:30 AM Los Angeles time
    • End Date
      21. June 2023