Process Scale-up & Tech Transfer for Injectables

    25 – 27 October 2021, online training

    Summary

    This three-day online training course is providing vital practical insights into QbD implemented Process Scale-up, Technology Transfer, and Process Validation for sterile injectable dosage forms.

    Who should attend?

    Injectables Technologists, Process Scientists, Process Engineers, Process Validation Specialists, CMO Managers, Technology Transfer Specialists, Manufacturing Management, Regulatory Affairs Managers, QC & QA Managers

    Learning Objectives

    • Understand industry approaches for Scale-up, Tech Transfer and PV applying QbD principles
    • Explore proven best practice in Scale-up and Tech transfer for sterile injectables
    • Take an excellent opportunity to discuss issues and challenges with industry peers
    • Gain practical knowledge from case studies

    Key Topics

    • QbD Principles during Process Development and Scale-Up
    • Process Scale-Up of sterile injectable dosage forms
    • Technology Transfer: Regulatory, Planning & Execution
    • Process Validation new guidance and requirements
    • Process Design Stage
    • Process Performance Qualification
    • Continued Process Verification
    • Process risk assessment

    Trainers

    Protea, CEO
    Laura has an extensive industrial experience in the development of drug products for the worldwide market, from scratch to registration, in accordance with GxP and ICH requirements.

    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