- Save the Date · Nov 3-4, 2027
- Conference
GMP & Quality Operations Summit
Inspection Readiness, Warning Letter Lessons & New-Site Startup, from the Quality Teams Living It
- Nov 3-4, 2027
- Dallas, TX
Special Rate ends December 31
Need approval? Download a justification letter
Overview
Ready for the Inspection You Haven't Scheduled.
Warning letters keep citing the same gaps: investigations that stop at the symptom, CAPAs that don’t stick, and quality oversight that can’t keep pace with operations. Those patterns are avoidable. This summit looks at how quality teams find and close them before an investigator does.
Built for quality operations
Sessions cover inspection preparation and hosting, recent warning letter trends, CAPA and deviation management, quality culture, and standing up quality systems at new sites.
From the quality teams living it
Speakers are quality heads and site leaders who have hosted inspections, responded to 483s, and launched new facilities, sharing what they would do the same and what they would change.
Outcomes
What you'll leave with
Inspection Readiness
Preparing the site, people, and records, running the front and back room, and responding to observations.
Warning Letter Lessons
What recent FDA warning letters cite most often and the systemic fixes that keep them from recurring.
New-Site Startup
Building the quality system, staffing, and validation plan for a new facility and reaching a state of control.
CAPA & Deviations
Root cause analysis that holds, effectiveness checks that mean something, and backlogs that stay under control.
Quality Culture & Management Review
Metrics, management review, and leadership behaviors that keep quality visible across the organization.
Data Integrity on the Floor
ALCOA+ in manufacturing records, batch review, and shop-floor systems.
Nov 3-4, 2027
Agenda Preview
- 7:15 – 8:15
Registration & Continental Breakfast
- 8:15 – 9:00
Opening KeynoteThe AI Factory: How Leading Manufacturers Broke Out of Pilot Purgatory
What the programs that reached validated production did differently, from choosing use cases to securing funding, and what stalled the rest. - 9:00 – 9:45
Regulator Keynote + Ask the RegulatorThe Regulator’s View: What Inspectors Expect When AI Runs Your GMP Process
How inspectors approach AI in GMP today, the evidence they ask for, and where draft Annex 22 and FDA guidance are heading. Ends with an open “Ask the Regulator” Q&A, so bring your questions. - 9:45 – 10:10
Networking Break · Exhibitor Showroom
- 10:10 – 10:50
AI Agents in the Deviation Workflow: From Triage to CAPA, With a Human Signing Off
How AI agents pull batch, equipment and lab data, draft the investigation and propose CAPAs, where the human reviewer stays in control, and how the workflow was validated for GMP use. - 10:50 – 11:30
Batch Record Review in Minutes, Not Days, and the Validation Package That Proves It
The review-by-exception approach, the time it saved, and the validation evidence that got it approved for commercial batches.
Who should attend
Built for the people who have to make AI work, and sign off on it, in a GMP environm
- VPs, Directors, and Heads of Quality
- Site Quality Heads
- QA and Compliance Managers
- CAPA and Deviation Leads
- Inspection Readiness Leads
- Regulatory Compliance
- Quality Operations
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 GMP & Quality Operations Summit.
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
Dallas, TX
November 3–4, 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 quality, compliance, and operations professionals in pharmaceutical, biotech, MedTech, and CDMO organizations.
Is there a virtual option?
No. GMP & Quality Operations Summit is an in person only event in Dallas, TX on November 3–4, 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.
