Process Scale-up, Validation & Technology Transfer

    28 – 30 March 2022, online training

    Summary

    This three-day training course is intended to provide insight 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 on how to translate theory into practice and overcome frequently faced challenges.

    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

    Learning Objectives

    • Understand industry approaches for Scale-up, Technology Transfer and PV applying QbD principles
    • Gain regulatory insights & guidance 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

    Programme

    • Training materials will be provided in digital form
    • All delegates will receive digital certificates of attendance 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.
    Online Participation
    1 650 Price incl. VAT: 1 650

    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.

    Lydia Makori

    l.makori@symmetric.events
    +421 222 200 543

    Training Details