Bianca van de Swaluw

Senior Life Science Consultant at QbD Group

Bianca is a Senior Life Science Consultant at QbD Group, delivering expert guidance on quality, regulatory, and compliance challenges across the life sciences industry.

2 articles

Qualification & Validation31 oct 2025 3 min

Analytical Method Validation: From One-Time Event to Lifecycle Approach

ICH Q2(R2) and Q14 redefine method validation as a continuous lifecycle. Learn how to keep analytical methods fit for purpose and inspection-ready.

Qualification & Validation30 abr 2025 5 min

Cleaning Validation in Pharma: Strategy & Best Practices

Cleaning validation ensures product safety in pharma. Discover types, methods, MACO limits, and how to build an efficient strategy with worst-case selection.

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