Quality Requirements for Solids

    Quality Requirements for Solids

    Dates TBC 2024, live online training


    This 3-day online training is a deep dive into the world of solids. You will obtain detailed information about the manufacturing and quality characteristics and intensify your know-how about the complex regulatory landscape. This course will cover the area of API manufacturing, as well as of finished product manufacturing with many examples (e.g. capsules, tablets, suppositories). In break-out sessions and in many case studies we will discuss different GMP challenges together and we will focus on recent findings by the authorities. Another topic will be the switch to Continuous Manufacturing – what are the requirements and how can CM be realized?

    Learning Objectives

    • Understand the regulatory landscape
    • Overview over GMP and quality requirements for the manufacture
    • Pharma 4.0 for solid manufacturing
    • Challenges for the manufacturing of different solid medicinal products
    • Modern process validation concepts
    • How to implement effective and smart IPC concepts
    • Implementation of analytical methods for solids

    Key Topics

    • Regulatory framework (EU-GMP Guideline, CFR, ICH guidelines e.g. Q9 and Q13, PIC/S, ISPE)
    • Quality & GMP requirements
    • Manufacturing challenges
    • Process validation
    • Pharma 4.0 and smart quality
    • Analytical methods
    • IPC requirements
    • Case studies for significant changes and follow-ups:
      • How to implement Continuous Manufacturing?
      • PAT for solid manufacturing areas
    • New breakout sessions during the course: You ask – the group discusses. Selected questions during the course will be discussed in the middle and at the end of each day to have an interactive course and to hear different opinions to a specific challenge

    Who should attend?

    Specialist from API and Solid Finished Product Manufacturing, Auditors for Solid Manufacturing Areas, 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
    Associate Director - Head of Compliance Launch and Technology Center
    Merck KGaA, Germany
    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 Solids

    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 breakout sessions were a nice way to interact with people from around the world and gain different perspectives on the process."
    Quality Control Manager, Boehringer Ingelheim

    "As my expertise is in sampling/inspecting incoming raw materials/components this training was a good overview of the OSD manufacturing process."
    Production Supervisor, Merck

    "The quality challenges section was very entertaining and informative."
    Quality Control Technician, Laboratorios Rubio

    "Defect Evaluation Lists and Analytical Methods for Solids Sessions were great."
    Quality Control Raw Material Compliance Specialist, Gedeon Richter

    "Multiple choice questions were good; break-out sessions were good; the trainer was very respectful and nice."
    Production Supervisor, Chiesi