Sterility Assurance University is the industry’s most focused event dedicated to microbiology, contamination control strategy (CCS), and sterility assurance across the product lifecycle. This two-day summit brings together leading experts…
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…
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…
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),…
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…
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…