Bruna Pastori Vinco

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Fresenius Kabi Deutschland GmbH
Validation & IT Quality Assurance Manager
I am Validation Manager responsible for enforcing that all CSV functionalities be executed in compliance with the legal requirements and for ensuring quality in the use of systems and laboratory equipment, through their validation, maintaining their status as validated/qualified .In the Validation area, I was responsible for managing and executing the validation processes concerning the infrastructure of computerized systems, spreadsheets, HVAC systems, compressed air, nitrogen, water purification and distribution system (PW and PWH), cleaning of production equipment (solids, liquids and semi-solids), processing of solids, liquids and semi-solids (production stage), and transportation of finished products. I also managed the qualification and requalification of all equipment and computerized systems at the plant (production and laboratory equipment), based on Risk Analysis (using the FMEA tool).

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The Road to Explainable AI in GXP-Regulated Areas
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The Road to Explainable AI in GXP-Regulated Areas

Recent advances in artificial intelligence (AI) have led to its widespread industrial adoption, with machine learning (ML) algorithms demonstrating advances in performance in a wide range of tasks. However, this comes with an ever-increasing complexity of the algorithms used, rendering such systems more difficult to explain.1

  • 1Samek, W., and K. R. Müller. “Towards Explainable...