Quality Requirements for Solids

    Quality Requirements for Solids

    12 – 14 June 2023, live online training

    Summary

    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

    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.
    solids

    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.

    Online Participation
    1 850  Price incl. VAT: 1 850 
    Equivalent of approx. 2 023 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
      12. 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
      14. June 2023
    What participants said about Symmetric courses

    "It is not at all frequent to find this grade of preparation and reaction to specific cases such as the ones presented. I'm enthusiastic! Thanks really."
    Tech Transfer Lead, Novartis

    "Practical examples were extremely useful and well presented."
    Senior Development Specialist, Bioton

    "Diving into the case studies and the ensuing discussion and learnings were great."
    Regulatory Affairs Specialist, Csl Behring

    "Excellent work of the lecturer, good materials, clear explanations."
    Clinical Pharmacologist, Boehringer Ingelheim

    "You succeed only when you are trained enough! Trust Symmetric's Training Team to achieve your goals."
    Analytical Developer, Gedeon Richter

    "Thank you for sharing all the links and informative material. Very professional organization and execution."
    Manufacturing Manager, Thermo Fisher Scientific

    "Very well organized event. Thanks and hope to work-learn from you again soon."
    Deputy Manager of Solid Dosage Forms Plant, Gedeon Richter

    "Many thanks for the invitation, organization of the training and the atmosphere. I found the course very well organised and presented."
    Formulation Manager, Curia