EU GMP Annex 1: Insights on total particles and TOC monitoring

In this expert webinar, Dr. Alessio Rosati (PQE) and Beckman Coulter Life Sciences explore best practices for environmental monitoring in sterile manufacturing, focusing on total particle monitoring, cleanroom compliance, and continuous TOC monitoring. Learn how to: • Design risk-based environmental monitoring programs • Optimize particle counter placement • Establish alert and action limits • Improve Grade A and Grade B monitoring strategies • Implement continuous TOC monitoring for water systems • Use trend analysis to detect issues early • Enhance contamination control and data integrity • Prepare for regulatory inspections with confidence Topics covered: EU GMP Annex 1 Environmental Monitoring (EM) Cleanroom Particle Monitoring ISO 14644 Considerations TOC Monitoring Pharmaceutical Water Systems Contamination Control Strategy (CCS) Sterility Assurance Data Integrity CAPA and Deviation Management Learn more about Beckman Coulter Life Sciences solutions for contamination control, particle counting, facility monitoring, and TOC analysis. #GMP #Annex1 #EnvironmentalMonitoring #Cleanroom #PharmaceuticalManufacturing #SterilityAssurance #ContaminationControl #TOCMonitoring #ParticleMonitoring #LifeSciences #BeckmanCoulter #DataIntegrity #Pharma #ISO14644 #QualityAssurance