Outline Setting the Stage: What “BLA Readiness” Means Role of QA & Compliance in CMC Success Process Characterization (PC) — Building the Knowledge Foundation Process Validation (PV) — Confirming Control and Consistency Key Compliance Elements for PC/PV Case Examples or Lessons Learned (CABA/OXB/CDMO examples) Forward Path: Ensuring Sustained State of Control Q&A

This training focuses on compliance in the pathway to Biologic License Application (BLA) readiness. Topics include transitioning from clinical to commercial, ensuring process control and reproducibility, alignment with ICH guidelines, and adherence to GMP requirements. Key sections cover Process Characterization (PC) and Validation (PV), critical for demonstrating robustness and regulatory alignment. Emphasis is placed on quality assurance, traceability, risk management, and documentation...