Drug-Device Combination Products: Quality & Regulatory Requirements

    23 – 25 March 2022, online training

    Summary

    The challenges associate with drug-device combination products are complicated as they must be registered either as pharmaceutical or medical device products. This course will help you navigate this complicated regulatory landscape. You will return with an understanding of the medical device world as it applies to your drug/device combination, including risk management, clinical considerations, and design control.

    Who should attend?

    This course is suitable for all those involved in:

    • Quality Control
    • Product Technology Transfer
    • Process Development
    • Medical Device Engineering
    • Production
    • Regulatory Affairs

    Learning Objectives

    • Understand the regulatory requirements for drug-device, device-drug combinations
    • Generate critical quality attributes and critical process parameters to design capable processes
    • Understand design control expectations
    • Examine best practices for working with medical device suppliers and manufacturers
    • Establish a control strategy to deliver safe and efficacious products
    • Understand the difference between CQAs and process parameters
    • Focus on the correct quality attributes

    Key Topics

    • Quality management systems
    • Critical quality attributes
    • Critical process parameters
    • EU MDR
    • Market access
    • Post-market surveillance
    • Key functional elements
    • ISOs

    Our online training experience includes

    • Live interactive format via the Zoom platform
    • Direct interaction with the trainer
    • Q&As, case studies, polls
    • Revisit recorded sessions for 30 days

     

    Programme

    • Training materials will be provided in digital form
    • All delegates will receive 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

    Price per delegate including:

    Online participation

    Online workbook & materials

    Certificate

    Revisit recorded sessions for 30 days

    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