Learning Level: Intermediate/Advanced
Session Length: 1.5 hours
Process validation stage 1, also known as process characterization (PCS), is the main step of generating process knowledge that is reported in filings. Statistical and data science procedures are frequently employed and regulatory requested to perform the main tasks such as setting a control strategy and risk classification of process inputs. In the webinar common practices, pitfalls, and open issues will be discussed for specific tasks within PCS such as scale down model qualification, experimental criticality assessment, and setting of a control strategy according to ICH Q8. Moreover, techniques will be presented to leverage knowledge across the process validation lifecycle into stage 2 (PPQ) and stage 3 (CPV).
- Data science workflow with critical steps to safely arrive at a regulatory compliant control strategy
- How to set up an ICH Q8 relevant control strategy
- Demystifying scale down model qualification