- Save the Date · Aug 10-11, 2027
- Conference
Sterility Assurance University
Contamination Control That Holds Up to FDA: CCS, Microbiology & Cleaning Validation
- Aug 10-11, 2027
- Philadelphia, PA
Special Rate ends December 31
Need approval? Download a justification letter
Overview
Contamination Control, Proven.
EU GMP Annex 1 made the contamination control strategy a requirement, and FDA investigators look just as closely at aseptic practice, EM trending, and cleaning. A CCS on paper isn’t enough. It has to be backed by data, connected across the site, and defensible during an inspection.
Built for sterile and controlled operations
Sessions cover cleanroom classification and qualification, disinfectant selection and efficacy, EM program design and trending, microbiology, and cleaning validation.
From the people doing it
Speakers are sterility assurance leads, microbiologists, and validation engineers who run these programs, sharing their data, their findings, and what investigators asked.
Outcomes
What you'll leave with
Cleanroom Classification & Qualification
ISO 14644 classification, airflow visualization, and requalification strategies that stay compliant without over-testing.
Disinfection Programs
Disinfectant selection, efficacy studies, rotation, and residue management that hold up to FDA and EU scrutiny.
Environmental Monitoring
Risk-based EM program design, alert and action limits, trending, and responding to excursions.
Microbiology & the CCS
Building and maintaining a site-wide contamination control strategy, with microbiology data at its center.
Cleaning Validation
Health-based exposure limits, worst-case selection, sampling recovery, and continued process verification for cleaning.
Aseptic Processing & Inspection Readiness
Aseptic behavior, media fills, and the contamination control findings that show up most often in 483s and warning letters.
Speakers
Practitioners from leading life sciences companies. More speakers to be announced.
Who should attend
Built for the people who have to make AI work, and sign off on it, in a GMP environm
- Heads of Sterility Assurance and Microbiology
- Validation Managers and Engineers
- Contamination Control Leads
- QC Microbiologists and EM Specialists
- QA and Compliance Managers
Group Pricing
Bringing 6 or more attendees?
Send your team for less. Tell us about your group and the KENX team will follow up with special group pricing for the Sterility Assurance University.
Group pricing
Tickets
Need approval to attend?
Download a justification letter
A ready-to-send letter for your manager with key sessions, takeaways and pricing.
Venue & Travel
Philadelphia, PA
Aug 10-11, 2027 · In person only
Venue and hotel room block details will be announced.
11 Events · North America & Europe
2027 Conference Schedule
Advance your professional development in the GxP and validation landscape.
Full agendas and registration coming soon at KENX.org
AI in GxP: Puerto Rico
Validation University
Process Validation & Equipment Qualification Across the Lifecycle, from the People Actually Doing It
AI in GxP: Pilot to Production to Scale
Real Deployments. Real Validation. Real Scale.
GxP Laboratory Summit
Analytical Methods, Data Integrity & Lab Modernization, from the People Running the Labs
CSV & CSA European Congress
Getting Ready for the New Annex 11: Risk-Based CSV & CSA in Practice
Sterility Assurance University
Contamination Control That Holds Up to FDA: CCS, Microbiology & Cleaning Validation
AI in GxP: Guardrails & Governance
Risk, Oversight, Model Monitoring, and Inspection Readiness for AI
GCP & Clinical Operations Summit
Making E6(R3) Work: Quality by Design, Vendor Oversight & AI in Clinical Trials
GMP & Quality Operations Summit
Inspection Readiness, Warning Letter Lessons & New-Site Startup, from the Quality Teams Living It
AI in GxP: Europe
Annex 22, Annex 11 & the EU AI Act, in the Heart of Europe’s Pharma Industry
CSV & CSA University
Less Paperwork, More Assurance: Making the Move from CSV to CSA
Who should attend?
This event is designed for professionals in Pharmaceutical, Biotech, MedTech, CDMO, Compounding and Outsourcing Facilities
Is there a virtual option?
No. Sterility Assurance University is an in person only event in Philadelphia, PA on Aug 10-11, 2027.
What's included in my pass?
Access to all sessions across both days, the exhibitor showroom, breakfast, lunch, networking refreshment breaks and the networking reception.
Are group rates available?
Yes. Registering 6 or more attendees? Use the group pricing form to request special group pricing.
What's the cancellation policy?
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.
How do I become a sponsor or exhibitor?
Use the Become a Sponsor or Become an Exhibitor links, or contact the KENX team to discuss opportunities.
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.
