Process Scale-up, Technology Transfer and Process Validation course applying QbD principles.

    Process Scale-up, Validation & Technology Transfer

    26 – 28 September 2022, live online training

    Summary

    This three-day training course is intended to provide insight into how state-of-the-art Process Scale-up, Technology Transfer, and modern Process Validation are tied together by applying Quality by Design principles. The regulatory requirements will be explained, and case studies will help you understand how to translate theory into practice and overcome frequently faced challenges.

    Learning Objectives

    • Understand industry approaches for Scale-up, Technology Transfer, and PV applying QbD principles
    • Gain regulatory insights & guidance on how to realize Technology Transfers and PV
    • Explore proven best practices in Scale-up for solid dose manufacturing processes
    • Gain practical knowledge and tools during two interactive sessions and workshops
    • Take an excellent opportunity to discuss issues & challenges with industry peers and with an expert

    Key Topics

    • QbD Principles during Process Development and Scale-Up
    • Scale-Up of Granulation and Tableting Process
    • Technology Transfer: Regulatory, Planning & Execution
    • Process Validation new guidance and requirements
    • Process Design Stage: Key input for Product and Process Quality
    • Process Performance Qualification
    • Continued Process Verification
    • Process risk assessment

    Who should attend?

    Pharmaceutical Technologists, Process Scientists and Process Engineers, Process Validation Specialists, CMO Managers, Technology Transfer Specialists, Manufacturing Management, Regulatory Affairs Managers, Quality Assurance Managers, Manufacturing Project Management

    Past participants

    • Manager Technology Transfer, Stada Arzneimittel
    • Research and Development Manager, Unipharm
    • Snr Technical Manager, Oriflame
    • Formulation Development Associate, Idorsia
    • Process Validation, Manufacturing, Packaging, Coripharma

    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
    • Digital and LinkedIn certificates

    Trainers

    Boehringer Ingelheim Pharma, Director Late Stage Drug Product Development
    Dr. Braun is a trained pharmacist with 20 years of experience in Drug Product Development. He received his Ph.D. in Pharmaceutical Technology at the University of Bonn and started his career in pharmaceutical industry as Head of Pharmaceutical Development at Rentschler Pharma.

    Process Scale-up, Validation & Technology Transfer

    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. 1 770 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
      26. September 2022
      09:00 AM Vienna time
      08:00 AM London time
      03:00 AM New York time
      12:00 AM Los Angeles time
    • End Date
      28. September 2022
    What participants said about this course

    "Thank you for the training, clear explanations and overviews about the different aspects to consider during transfer for also validation and development."
    R&D Support for Tech Transfer, Mithra Pharmaceuticals

    "Thanks for this training! That was my first training ever. I've learned a lot, the organisation was perfect."
    R&D Industrialization Project Officer, Mithra Pharmaceuticals

    "Very well organized and relevant training."
    Pharmaceutical Technology Manager, PharOS

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