Process validation for additive manufacturing in the medical device industry

The training course offers you the opportunity to acquire in-depth knowledge on the topic of qualification & validation in the medical device industry. You will be comprehensively introduced to the topic, which plays a decisive role in ensuring product quality and compliance with regulatory requirements such as ISO 13485. By focussing on the phases of qualification and validation, you will gain the necessary tools to manage complex processes safely and effectively. By participating, you will not only acquire technical expertise, but also the competence to establish and continuously improve valid processes in the additive manufacturing of medical devices. The training focuses on hands-on as well as practical and pragmatic solutions.

Content

> Basics of qualification & validation in the medical device industry
    - Regulatory requirements including for ISO 13485
    - Phases of qualification & validation
    - Risk-based approach
  Equipment qualification and process studies in the medical device industry
   - Installation qualification (IQ)
   - Basics and tools of process studies
  Process stability through validation
   - Worst-case analyses in functional qualification (OQ)
   - Repeatability and reproducibility in performance qualification (PQ)

Practice
     - Comparison between different printing processes
   - Process sequences and materials
   - Process of FLM printing
    Process studies in additive manufacturing
   - Influence of process variations on component quality
   - Identification and optimisation of critical printing parameters
  Valid additive manufacturing of medical devices
  - Process monitoring and test methods
  - Fundamentals and application of change control

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