novatek international event

SPEAKER: KENX Laboratory University | Philadelphia, PA

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…

novatek international event

HYBRID CONFERENCE & SPEAKER: KENX Validation University

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…

novatek international event

Digitizing your Cleaning Validation Program and Strategy

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,…

novatek international event

Speaker: KENX Validation & GMP University

We’re excited to sponsor Validation & GMP University! Take a look below to see our session spotlights: Annex 1 Contamination Control — What the Recent Revision Means for Validation, Parsa Famili, President & CEO, NOVATEK INTERNATIONAL Risk-based Cleaning Validation – Key Elements for Success, Susan B. Cleary, B.Cs, M.B.A., Director of Product Development, NOVATEK INTERNATIONAL  Validation & GMP…

novatek international event

VIRTUAL EVENT: Dublin Validation University

Knowledge Exchange Network (KENX) is very excited to announce their Validation University is returning virtually to Ireland this fall. The event is a dream come true for engineering, quality, C&Q and validation professionals by offering hands-on training for the pharmaceutical, biotech, medical device and related industries. Participants create their own experience by choosing from over…

novatek international event

SPEAKER: KENX Laboratory University

Laboratory University contains 3 amazing events at one location! Create your own event by choosing from over 40 knowledge exchanges tutorials, including: Analytical Procedures & Methods Validation Life Cycle Management and Training Implementation Risk-Based Test Method Validation Analytical Transfer and Comparability Studies Method Variation – Handling Measurement Uncertainty Stability-Indicating Analytical Methods Criteria for System Suitability Testing…

novatek international event

TRAINER: Change Control & Program Management Virtual Training Event

Effective change management is a critical component in your Quality System. A robust program should ensure procedures are justified, reviewed and approved by your quality unit. This seminar outlines the steps needed to build an effective program from the ground up. Top issues such as; implementing a risk-based approach, training personnel, identifying risks, monitoring effectiveness…

novatek international event

SPEAKER: KENX Cleaning University

Many companies spend exorbitant amount of money and time on the qualification of cleanrooms and the validation of product manufactured within. KENX is proud to present a one-stop-shop for professionals tasked with the contamination control and disinfection, cleanroom design, environmental monitoring and cleaning validation practices at their facility. This hybrid conference showcases those paving the…