The Big Restructure- System Risk Assessment & The Benefits in Application


CET Berlin
16:00 - 17:30


Feb 15 2023

Learning Type

Free Live Webinar


During Validation and qualification projects, we always have conversations regarding the impact a particular element has on product quality or patient safety. However, finding the right tool for applying a risk-based approach to the commissioning and qualification activities can be difficult.

Combining the dots between a test failure and a link to product impact or a Critical Process Parameter (CPP) can help keep the qualification on track.

If you answer Yes to one of those questions, this webinar can help you out take your risk activities to the next level:

  • Do your Validation Specialists, Validation Engineers, and stakeholders need a quick way to identify the impact of a deviation on a system, product, or patient safety?
  • Do they waste time due to a lack of understanding of a particular component’s impact on the product or patient safety?
  • Are you searching for a better risk assessment tool to inform your C&Q activities?
  • Are you looking for an alternative to FMEA to help support compliance with regulatory requirements and ICH Q9?

This webinar will discuss the risk assessment tools available in the industry, System Risk Assessment (SRA), best practices, and regulatory guidelines. We will also share real-life learning from the practical application – the good, the bad, and the ugly.

  • Who Should Attend:

    Anyone who deals with system validation and qualification, such as QA Managers, QC Managers, Validation Managers/Engineers/Specialists/Technicians.

  • Skill Level: Novice, Intermediate
  • Topics:

    Topic 1

    - Type of tools
    - Differences in tools
    ​​​​​​​- What they deliver

    Topic 2

    - Connecting documents
    - Areas to be mindful of and questions to consider
    ​​​​​​​- Content not discussed in industry best practice

    Topic 3 - Practical Application

    - Lessons Learned
    ​​​​​​​- Benefits experienced

  • Special event information:

    All participants will get a free certificate of attendance courtesy of our event's sponsor Qualifyze.


  • Laura Butchart
    Laura Butchart
    Validation Project Specialist

    Laura is a commissioning, qualification, and validation specialist with a wealth of experience, holding a Master’s degree in Pharmaceutical Validation Technology from TU Dublin.

    She has been performing CQV activities for over 15 years in major companies such as Thermo Fisher Scientific, Novartis, Patheon, and Lonza.

    Laura has delivered successful validation projects for start-up companies and large capital projects. Her experience includes equipment qualification, facility qualification, validation of computer systems, cleaning validation, and environmental validation.

    She is the co-author of the article The Big Reshuffle — Impact Assessments and System Criticality, published on KENX Insights.




The Qualifyze mission is to build the trust layer for global supply chains by creating a digitally connected ecosystem. They operate the first online platform for GxP audits that connects pharma companies, suppliers, and auditors.

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Local Time

  • Timezone: Asia/Singapore
  • Date: Feb 15 - 16 2023
  • Time: 23:00 - 00:30

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