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 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:…