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HYBRID CONFERENCE & SPEAKER: KENX Cleanroom Validation, Disinfection & EM
April 27, 2022 @ 8:00 am - April 29, 2022 @ 5:00 pm
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of Annex 1 as it applies the sterile environment and FDA’s Quality Consideration in Non-Sterile Drug Manufacturing Draft Guidance, the time has never been greater to ensure you have procedures mastered to comply with regulatory authorities.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 way in best practices in cleanroom qualification, disinfection, contamination control, environmental monitoring and more. As a bonus, the event is co-located with Cleaning Validation and Critical Cleaning Processes and has over 40 tutorials to enhance your professional development.
Join KENX at industry’s cleanroom validation event of the year! Whether you’re in QA, validation, or engineering; a novice or advanced professional; or, attending in-person or online, this is your chance to network with over 200 of like-minded colleagues in the FDA-regulated environment.
Novatek Speaker Session:
Trending as part of a contamination control strategy
Susan Cleary B.CS, EMBA – Direct Product Development, Novatek International
- Overview on regulations and guidelines on EM data analysis
- Understand EM Trending Requirements
- Learn How to Trend & Analyze Environmental Monitoring Data
- Considerations for EM data analysis using computerized systems
Takeaway Tools
- Example Trend Reports
- Root cause assessment data fields list
- Trending requirements examples for on demand, weekly, monthly, quarterly, and annual review