Oliver Steinhof

Oliver Steinhof

Company: Biogen

Job title: Senior scientist, PAT


Sensing Technology and Process Requirements 12:00 pm

• PAT in the product life cycle – how to connect process needs with technology • PAT technology readiness: what’s out there, what’s needed? • Data engineering for PAT • Compliance aspects – data integrity and GMP, monitoring vs. controllingRead more

day: Stream 2 - Day 2

Panel Discussion: Measure Vs Model in CM Validation & Approval 9:00 am

• What measurements can be replaced with a model, whilst retaining product quality and regulatory compliance? • How can regulatory approval for CM differ across the world? • Key differences between traditional bath processing vs continuous in regulatory submission, e.g. continuous process validation • Inspection preparedness as we move into commercial spaceRead more

day: Day Two

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