- Save the Date · Jun 2-3, 2027
- Conference
GxP Laboratory Summit
Analytical Methods, Data Integrity & Lab Modernization, from the People Running the Labs
- Jun 2-3, 2027
- San Diego, CA
Special Rate ends December 31
Need approval? Download a justification letter
The Lab Is Where
Quality Gets Proven.
Every release decision rests on laboratory data. Inspectors know it, and so do warning letters. Method lifecycle, data integrity, OOS investigations, and aging lab systems remain among the most frequently cited areas in GxP inspections.
Sessions span analytical quality and control, stability testing and program management, and data integrity: from method development, validation, and transfer to predictive stability modeling, OOS, OOT, and OOE investigations, and digital lab systems.
Speakers are lab directors, QC managers, and analytical scientists who run regulated labs every day, sharing what worked, what didn't, and what the inspector asked.
Every Step Is an
Inspection Point.
Follow a result from sample to release, and where data integrity risk shows up along the way.
Sample
Receipt, chain of custody, and storage.
Method
A validated, fit-for-purpose analytical procedure.
Data
Acquisition in CDS, LIMS, and connected instruments.
Review
Second-person review of data and audit trails.
Release
A result the quality unit can stand behind.
What You'll Take Home.
Six themes across analytical quality, stability, and data integrity.
Analytical Method Lifecycle
Applying ICH Q14 and USP <1220> from method design through validation, transfer, and continuous verification, with system suitability and trending that keep methods reliable over time.
Stability Testing &
Program Management
Designing stability-indicating methods, meeting ICH, FDA, and EU expectations, and moving stability programs beyond spreadsheets and silos.
Predictive Stability
& Real-Time Release
Using predictive modeling, accelerated and stress testing, and modern analytics to forecast shelf life and rethink traditional stability approaches.
OOS, OOT &
OOE Investigations
Advanced case studies on finding true root causes in QC and stability programs, and preventing recurrence through robust data evaluation.
Data Integrity by Design
Building integrated digital controls, audit trail review, and quality risk management into analytical operations from the start.
AI & Lab Modernization
AI and machine learning in method optimization and data review, digital method development, and the LIMS, ELN, and automation behind them.
Agenda
Coming Soon.
Two days of case studies, practical sessions and panels are being finalized now. Be the first to see the full program when it's released.
Get the agenda first
Enter your work email and we'll send it the moment it's live.
Learn from the Teams Doing the Work.
Our faculty brings together analytical, QC, stability, and data integrity leaders from global manufacturers, emerging biotechs, and the regulatory community. Speaker announcements are coming soon.
Faculty is being finalized and will be announced shortly. Check back for updates.Why GxP Laboratory Summit.
Practitioners, Not Pitches
Our speakers are drawn primarily from manufacturers and sponsors who do this work every day. Every session is vetted by an industry advisory board to keep the content practical and vendor neutral.
Case Studies with
the Details Left In
Hear what worked, what failed, how long it took, and what the documentation actually looked like.
Small Enough to
Talk to Everyone
A focused, in person audience means real conversations with speakers and peers, not a sea of badges.
Thirty Years of GxP Focus
KENX has served pharma, biotech, and MedTech compliance professionals for three decades. This is a community that speaks your language.
Leave with a Plan
Walk away with frameworks, templates, and contacts you can put to use the week you get back.
Built for the People Running the Labs.
This event is designed for analytical, QC, stability, and quality professionals in pharmaceutical, biotech, MedTech, CDMO, and contract testing organizations.
Functions
- Quality Control
- Analytical Development
- Stability Testing and Program Management
- Quality Assurance
- Laboratory Informatics
- Data Integrity and Compliance
- Method Validation and Transfer
Titles
- Lab Directors and QC Managers
- Analytical Scientists and Lab Supervisors
- Stability Program Managers
- Data Integrity and LIMS Leads
- QA and Compliance Managers
Organizations
- Pharmaceutical
- Biotech
- MedTech
- CDMO
- Contract Testing Labs
“A highly informative and practical conference that delivered real insights and actionable strategies. Truly worth attending.”
Venue & Travel
San Diego.
June 2–3, 2027 · In person only
Venue and hotel room block details will be announced.
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 Validation & Qualification Summit.
Group pricing
GxP Laboratory Summit
Register by December 31, 2026 for a special rate: $1,495 per attendee ($500 off)
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 analytical, QC, stability, and quality professionals in pharmaceutical, biotech, MedTech, CDMO, and contract testing organizations.
Is there a virtual option?
No. GxP Laboratory Summit is an in person only event in San Diego, CA on June 2–3, 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. Register 4–5 attendees and receive an additional $100 off each ticket; add Group Rate tickets in the ticket calculator. For 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 link, 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.
