This webinar series provides an introductory yet comprehensive overview of cleaning validation principles and requirements that are crucial for ensuring the effectiveness of cleaning as well as compliance with GMP requirements. Speakers: Vivien Santillan, Director Asia Dr. David Vincent, CEO VTI Lifesciences Learning objective: To understand the Requirement of cleaning validation in GMP To understand…
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,…
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…
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…