Do your validation specialists, validation engineers and stakeholders need a quick way to identify the impact of a test deviation on a system, product or patient safety? Have your validation specialists or engineers had time wasted due to lack of understanding a particular component has on product or patient safety? Are you searching for a better risk assessment tool to inform your C&Q activities? Or looking for an alternative to FMEA to help support compliance with regulatory requirements and ICH Q9? Finding the right tool for application of risk-based approach to the commissioning and qualification approach can be difficult.
Finding a tool that solves the problem but without experience can be a leap of faith. In the depths of a project implementation is often when key conversations occur regarding the impact a particular element has on product quality or patient safety. Being able to join the dots between a test failure and link to product impact or a Critical Process Parameter (CPP) rapidly can keep the qualification of a system on track This webinar will discuss the risk assessment tools available in industry best practice, regulatory guidelines and share insight and lessons learned for implementation. This webinar will discuss real life learning from practical application – the good, the bad and ugly.
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.
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