Gabriele Bano

Company: GSK

Job title: Modelling Team Leader- Biopharmaceuticals

Seminars:

Fireside Chat: Complexity of Model Requirements – Addressing Potential Variability in Raw Materials & Changes in Hardware 4:00 pm

Variability can arise from supplier changes or variations in process/starting materials, process equipment or the process itself Automation of model calibration and validation may solve some issues, but how does post approval changes for model impact regulatory status? How can we maintain the accuracy and precision of PAT sensor equipment during process conditions and over…Read more

day: Day Two

Multivariate Statistical Process Monitoring (MSPM) for Real-Time Intervention and Multivariate Analysis (MVA) for Retrospective Assessment in Commercial Biopharmaceutics Manufacturing 11:30 am

Detection of real-time events such as process drifts, probe failures, and erroneous operators’ intervention, which enables early fault detection and near real-time intervention Enable improved tech transfer of processes into commercial manufacturing Moving from low to medium impact models (according to regulatory ICH Q8 classification) and integration of models into routine manufacturing operationRead more

day: Day Two