Novatek interviendra et parrainera le webinaire de l'affilié philippin de l'ISPE de septembre sur les directives PIC/S relatives aux BPF et à l'intégrité des données. Novatek présentera les meilleures pratiques en matière d'intégrité des données et les systèmes de gestion des informations de laboratoire (LIMS) basés sur les risques. Frais de webinaire : PHP 1,500.00…
The regulations are evolving as are the processes we use to validate and monitor controlled areas and utility systems. Automating these processes and digitizing the data is a must to ensure regulatory compliance and process control. This session will review the regulations regarding the trending and data analysis requirements and which trending tools are applicable…
European Annex 1 encourages companies to develop a “Total Contamination Control Strategy” (TCCS). TCCS starts with proper determination of Maximum Safe Carryover (MSC), calculated based on health-based exposure limits (HBELs), a routine cleaning program to evaluate effectiveness of the steps used, followed by microbial Environmental Monitoring, Water and Utilities Monitoring, HVAC filter qualifications, Media Fills,…
