Sterility Assurance University
Advancing Microbiology, CCS, Cleaning Validation, EM & Digital Tools Across the Lifecycle
Platinum Sponsor
Gold Sponsors
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
