Novatek will be both speaking and sponsoring September’s ISPE Philippines Affiliate’s webinar on PIC/S Guidance on GMP and Data Integrity. Novatek will be presenting on Data Integrity best practices and Risk-Based Laboratory Information Management Systems (LIMS). Webinar Fee: PHP 1,500.00 - ISPE Members, FDA, Government, and Students PHP 2,500.00 – Non ISPE Members Register at:…
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,…
