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

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        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

        Dr. Michael Braun
        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.

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        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
        • Email
          l.makori@symmetric.events
        Request in-house
        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