Medical device training with James Pink

    Process Design, Scale-up and Technology Transfer for Medical Devices

    New dates TBC, online training

    Summary

    This interactive 3-day training will provide you with practical tools and knowledge for process risk assessment during scale-up and technology transfer of medical devices. You will receive an in-depth update on the regulatory landscape, presented interactively through case studies involving a cannula, femoral prosthesis, and an infusion pump.

    Learning Objectives

    • Navigate the complex medical device regulatory landscape
    • Understand how to manage process and design changes
    • Learn how to use statistical methods
    • Gain new perspectives on how to design in quality (QbD principles)
    • Build transparent and methodical processes to achieve commercial-scale production

    Key Topics

    • FDA & EU regulatory requirements
    • Using standards
    • Statistical methods
    • Risk Management Process
    • Quality by design Principles
    • Managing suppliers
    • Design planning/validation/transfer/scale-up
    • Process planning/validation/transfer/scale-up

    Who should attend?

    This course is designed for those involved with quality assurance, regulatory, engineering, manufacturing in medical device design, development and manufacturing.

    • Quality Managers & Engineers
    • Medical Device Engineers
    • Manufacturing Engineers
    • Process Engineers
    • Validation Managers, Engineers and Technicians
    • R&D and Product Development Managers, Engineers and Scientists

    Past participants

    • Senior Process Expert, B. Braun
    • Head of Primary Packaging & Process Development, Boehringer Ingelheim
    • Tech Transfer Operations Lead, Novartis
    • Process Development Manager, Stevanato Group
    • Product Transfer, Biokit

    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

    Health Sciences and Medical Devices Consultant
    James Pink has over 20 years of experience in the medical devices industry including 10 years as a healthcare technology expert and lead auditor for a leading European notified body.
    Online Participation
    1 650  Price incl. VAT: 1 650 
    Equivalent of approx. 1 713 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.

    Lydia Makori

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

    Training Details
    What participants said about this course

    "No issues, for me the course was brilliant, I was impressed with the digital format. Thanks a lot!"
    Senior Technology Transfer Scientist, Quotient

    "Very insightful. James is very knowledgeable on the topic and all aspects that form part of ISO13485 and is very well prepared and organized."
    Product Transfer Manager, Biokit