Facing FDA Scrutiny with Confidence: Strengthening Control to Prevent Losses and Ensure Sterility
EducationalTACKLING PRODUCTION CONTROL CHALLENGES IN PHARMA
2026-05-27 | 05:00 PM - 05:15 PM | TPD Room
Abstract
- Mapping loss points: filter integrity issues, vial defects, overfill strategies, improper handling
- Root causes of sterility loss: airflow disruption, gloveport issues, poor intervention discipline
- How FDA evaluates your contamination control strategy (CCS)
- Ensuring compliance with Annex 1, cGMP, and updated FDA expectations
- Building a “single source of truth” for batch documentation
- Using deviation trending to identify systemic weaknesses
- Practical steps for improving audit readiness on the filling floor shorten it
