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…
SAVE $200 off your registration with CODE: Novatek200 55 Tutorials Overflowing with Rich Content and Tangible Takeaways for the CQV Universe Facility Commissioning & Equipment Qualification Implement a Risk-based Verification Strategy Design a Risk-based IQ, OQ, and PQ Approach Manage Process Validation Tech Transfers Qualify Critical Utility Systems – HVAC, Water and Gas Process Validation…
SAVE $200 off your registration with CODE: Novatek200 With the impending changes of Annex 1 as it applies the sterile environment and FDA’s Quality Consideration in Non-Sterile Drug Manufacturing Draft Guidance, the time has never been greater to ensure you have procedures mastered to comply with regulatory authorities. KENX’s hybrid conference showcases those paving the…
The time has never been greater to stay up-to-speed with current regulatory thinking. Join Novatek at KENX's Laboratory University and stay up to date with the latest developments and regulations in Analytical Procedures & Methods Validation, Stability Testing & Program Management, and FDA Inspections of Quality Control Laboratories. Novatek Presentation: Elements of Sample Control-Compliance, Inventory & Tracking…