- Conference
Sterility Assurance University
Advancing Microbiology, CCS, Cleaning Validation, EM, Digital Tools & Risk-Based Strategies Across the Lifecycle
- San Diego, CA
- August 12-13
- Prices increase July 17!
Attend Virtually or In-Person
Top 10 Challenges STERILITY ASSURANCE LEADERS are solving IN 2026





Gold Sponsors
Overview
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 from pharma, biopharma, and device organizations to share actionable insights on Annex 1 implementation, environmental monitoring, aseptic processing, and cleaning validation — including lifecycle development, data-driven approaches, and regulatory alignment. Whether you’re preparing for inspections or proactively strengthening your programs, this is your go-to event for expert guidance, peer networking, and practical tools.
Top 10 Reasons to Attend
- Implement a site-wide CCS aligned with Annex 1 and current regulatory expectations
- Explore environmental monitoring design, trending, and excursion investigations
- Strengthen your cleaning validation lifecycle from acceptance limits to tech transfer
- Discover strategies for managing microbial excursions and aseptic process failures
- Learn from real-world case studies on gowning, airflow, smoke studies, and visual inspection
- Understand rapid methods, automation, and AI for proactive microbial control
- Benchmark personnel monitoring and objectionable organism risk assessments
- Identify design and facility risks that impact contamination control
- Take home SOPs, checklists, and other takeaway tools you can apply immediately
- Hear directly from Sanofi, Takeda, Alcon, Charles River Laboratories, and Bausch + Lomb as they share how they’re advancing sterility assurance and contamination control
Who Should Attend
- Microbiology & Environmental Monitoring Professionals
- Quality Assurance & Quality Control Leaders
- Validation, Sterility Assurance & Aseptic Processing Personnel
- Regulatory Affairs & Inspection Readiness Teams
- Facilities, Engineering & Cleanroom Design Specialists
- Manufacturing, Operations, and Technical Services
- R&D and Process Development Teams
- Consultants and Service Providers in the Sterility Space
This was one of the most effective conferences I ever attended: very well organized with choices and knowledgeable presenters.
Great convention. I enjoyed the presentations and seeing the passion there is for doing the right thing in the industry. Very refreshing.
I thoroughly enjoyed attending the conference. The relaxed and low-key atmosphere fostered a strong sense of engagement among the audience and created a comfortable space for openly sharing insights. I particularly appreciated the attendees’ openness to learning and their willingness to kindly share their experiences and expertise. I also greatly valued the productive discussions both at the end of the presentations and during the networking breaks. It truly felt like a collaborative and enriching environment. Thank you for organizing such a great event!
Attending the Sterility Assurance University conference was a game-changer. The sessions were packed with cutting-edge insights, practical strategies, and real-world case studies that elevated our understanding of contamination control and regulatory compliance. The speakers were industry leaders who brought clarity to complex topics, and the networking opportunities were invaluable. We left feeling empowered, informed, and ready to implement best practices with confidence.
All speakers were informative, with good detailed presentations. Everyone was professional, and very easy to speak with, the conference was on point.
Please Note: KENX does not issue refunds. If you are unable to attend after registering, we are happy to apply your registration fee toward a future KENX event or transfer your registration to a colleague. All cancellation or transfer requests must be received at least seven days prior to the event.



















