One of the first elements of any regulatory audit is to analyze and scrutinize a firm’s investigation reports and review how they control their manufacturing and laboratory processes. Considering this, it is critically important for patient safety as well as quality compliance that both investigations and how the firm demonstrates process control is done right the first time.In this webinar, presented with personnel from the qualification subject matter experts at Biogen, we’ll review real-world examples that showcase how they developed a plan for utilizing the automation functionalities and data generation capabilities with Cortex™.
- Matthew Paquette, MBA, Product Specialist, Charles River
- Stephen Spence, Candidatus Scientiarum, Qualification SME, Biogen (Denmark) Manufacturing ApS
- Svend da Silva, Sr. Associate II, Global QC Operations, Biogen (Denmark) Manufacturing ApS
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