Design Control and Risk Management for Combination Products training

    Design Control and Risk Management For Combination Products

    12 – 14 March 2024, online training


    The course has been developed to introduce you to the international requirements for design control and risk management of combination products. There is a particular emphasis on drug – device combinations and drug delivery devices that are regulated as combination products or drug-device combinations in Europe requiring the notified body opinion (NBOp).

    We assume no prior knowledge of design control or risk management as many of the attendees will be more familiar with pharmaceutical regulation and cGMP.

    Our course is based upon worked examples facilitated by the tutor but also enables participants to discuss their products (without breaching intellectual property restrictions!).

    The sessions are a blend of regulatory requirements discussing in particular ISO13485:2016 section 7.1 and 7.3 in particular but also CFR21 Part 4 and CFR21 Part 820.30.

    Learning Objectives

    • Critically evaluate product design to ensure compliance with essential safety and performance requirements
    • Understand the regulatory requirements for drug-device, device-drug combinations
    • Understand design control expectations
    • Identify requirements of key International Standards and regulatory requirements relative to risk management and design control
    • Understand the importance of human factors and useability engineering
    • Identify how risk management affects quality management system practices

    Key Topics

    • Risk management and design control fundamentals
    • Standards and regulations
    • Usability engineering
    • Design Controls Requirements
    • Design Changes
    • Post-approval
    • Risk Analysis, Evaluation And Controls

    Who should attend?

    This course is suitable for all those involved in:

    • Regulatory Affairs
    • Quality Control/ Assurance/ Engineering
    • Product Development/ Engineering/ Technology Transfer
    • Process Development
    • Research & Development

    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 7 days
    • Training in digital format
    • Digital and LinkedIn certificates


    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.

    Design Control and Risk Management For Combination Products

    Download the full training agenda to reveal complete session details, training takeaways, case studies, daily schedule, special features and full trainer bio.

    Online Participation
    1 850  Price incl. VAT: 1 850 
    Equivalent of approx. 2 073 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


    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
    +421 222 200 543

    Training Details
    • Start Date
      12. March 2024
      09:00 AM Vienna time
      08:00 AM London time
      04:00 AM New York time
      01:00 AM Los Angeles time
    • End Date
      14. March 2024
    What participants said about Symmetric courses

    "It is not at all frequent to find this grade of preparation and reaction to specific cases such as the ones presented. I'm enthusiastic! Thanks really."
    Tech Transfer Lead, Novartis

    "Practical examples were extremely useful and well presented."
    Senior Development Specialist, Bioton

    "Diving into the case studies and the ensuing discussion and learnings were great."
    Regulatory Affairs Specialist, Csl Behring

    "Excellent work of the lecturer, good materials, clear explanations."
    Clinical Pharmacologist, Boehringer Ingelheim

    "You succeed only when you are trained enough! Trust Symmetric's Training Team to achieve your goals."
    Analytical Developer, Gedeon Richter

    "Thank you for sharing all the links and informative material. Very professional organization and execution."
    Manufacturing Manager, Thermo Fisher Scientific

    "Very well organized event. Thanks and hope to work-learn from you again soon."
    Deputy Manager of Solid Dosage Forms Plant, Gedeon Richter

    "Many thanks for the invitation, organization of the training and the atmosphere. I found the course very well organised and presented."
    Formulation Manager, Curia