GMP & Quality Operations Summit

Special Rate $1,495
Get Tickets
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

  1. 7:15 – 8:15

    Registration & Continental Breakfast

  2. 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.
  3. 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.
  4. 9:45 – 10:10

    Networking Break · Exhibitor Showroom

  5. 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.
  6. 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.
Nov 3-4, 2027
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

This field is for validation purposes and should be left unchanged.
Full name(Required)

Tickets

From $1,395
Need approval to attend?

Download a justification letter

A ready-to-send letter for your manager with key sessions, takeaways and pricing.

Download letter (PDF)
Venue & Travel

Dallas, TX

November 3–4, 2027 · In person only
Venue and hotel room block details will be announced.

★★★★★

"One of the most practical conferences on AI in GxP and Life Sciences I’ve attended. I walked away feeling that I gained new knowledge and actionable insights that I could put into practice at work the very next day."

Senior Team Lead
DSV A/S
★★★★★

"The speakers were extremely knowledgeable! I enjoyed every single topic that was discussed and the conference had my full attention!"

Senior Manager, QA
BioAgilytix
★★★★★

"This event really raised the awareness of the emerging trend of AI in the GxP space. I hope KENX does another one similar to this. The networking discussions really make the event come alive."

Director
Taiho Oncology
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

Mar 31-Apr 1
San Juan, PR

AI in GxP: Puerto Rico

Predictive Quality, Real-Time Release & Automation on the Plant Floor
Apr 20-21
Chicago, IL

Validation University

Process Validation & Equipment Qualification Across the Lifecycle, from the People Actually Doing It

May 11-12
San Francisco, CA

AI in GxP: Pilot to Production to Scale

Real Deployments. Real Validation. Real Scale.

Jun 2-3
San Diego, CA

GxP Laboratory Summit

Analytical Methods, Data Integrity & Lab Modernization, from the People Running the Labs

Jun 15-16
Dublin, Ireland

CSV & CSA European Congress

Getting Ready for the New Annex 11: Risk-Based CSV & CSA in Practice

Aug 10-11
Philadelphia, PA

Sterility Assurance University

Contamination Control That Holds Up to FDA: CCS, Microbiology & Cleaning Validation

Sep 28-29
Boston, MA

AI in GxP: Guardrails & Governance

Risk, Oversight, Model Monitoring, and Inspection Readiness for AI

Oct 13-14
RTP, NC

GCP & Clinical Operations Summit

Making E6(R3) Work: Quality by Design, Vendor Oversight & AI in Clinical Trials

Nov 3-4
Dallas, TX

GMP & Quality Operations Summit

Inspection Readiness, Warning Letter Lessons & New-Site Startup, from the Quality Teams Living It

Nov 16-17
Frankfurt, Germany

AI in GxP: Europe

Annex 22, Annex 11 & the EU AI Act, in the Heart of Europe’s Pharma Industry

Dec 8-9
Philadelphia, PA

CSV & CSA University

Less Paperwork, More Assurance: Making the Move from CSV to CSA

FAQ

Frequently asked questions

Still have a question? Book a call →

Who should attend?

This event is designed for quality, compliance, and operations professionals in pharmaceutical, biotech, MedTech, and CDMO organizations.

No. GMP & Quality Operations Summit is an in person only event in Dallas, TX on November 3–4, 2027.

Access to all sessions across both days, the exhibitor showroom, breakfast, lunch, networking refreshment breaks and the networking reception.

Yes. Registering 6 or more attendees? Use the group pricing form to request special group pricing.

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.

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.

CSV & CSA University

Special Rate $1,495
Get Tickets
Overview

Less Paperwork. More Assurance.

FDA’s Computer Software Assurance approach asks manufacturers to focus effort on what affects product quality and patient safety. Most teams agree with the idea. Fewer have changed how they plan, test, and document. This university is built to close that gap.

Built as a university

Two days of practical, step-by-step sessions that take you through a CSA-based validation lifecycle, from risk assessment to test strategy to the final record.

From the people doing it

Instructors are validation and quality leaders who have moved their own programs to CSA, and they bring the templates, examples, and inspection experience to prove it works.

Outcomes

What you'll leave with

CSA in Practice

Applying critical thinking and intended use to decide how much assurance each system and feature needs.

Risk-Based Testing

Choosing between scripted, unscripted, and exploratory testing, and documenting each the right way.

Supplier Assessment

Using vendor documentation and audits to reduce duplicate testing without giving up control.

Digital Validation

Moving from paper to digital validation tools, and validating those tools along the way.

GAMP 5 Second Edition

How GAMP 5 Second Edition supports CSA, agile delivery, and modern system lifecycles.

Data Integrity & Periodic Review

Keeping systems in a validated state with audit trail review, change control, and periodic review.

Who should attend

Built for the People Who Have to Control AI.

  • Heads of Validation and IT Quality
  • Validation Engineers and Analysts
  • CSV and CSA Managers and Specialists
  • QA and Compliance Managers
  • System Owners and Business Process Owners
  • IT and Business Systems
  • Manufacturing Systems
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 CSV & CSA University

Group pricing

This field is for validation purposes and should be left unchanged.
Full name(Required)

Tickets

From $1,395
Need approval to attend?

Download a justification letter

A ready-to-send letter for your manager with key sessions, takeaways and pricing.

Download letter (PDF)
Venue & Travel

Philadelphia, PA

Dec 8-9, 2027 · In person only
Venue and hotel room block details will be announced.

★★★★★

"One of the most practical conferences on AI in GxP and Life Sciences I’ve attended. I walked away feeling that I gained new knowledge and actionable insights that I could put into practice at work the very next day."

Senior Team Lead
DSV A/S
★★★★★

"The speakers were extremely knowledgeable! I enjoyed every single topic that was discussed and the conference had my full attention!"

Senior Manager, QA
BioAgilytix
★★★★★

"This event really raised the awareness of the emerging trend of AI in the GxP space. I hope KENX does another one similar to this. The networking discussions really make the event come alive."

Director
Taiho Oncology
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

Mar 31-Apr 1
San Juan, PR

AI in GxP: Puerto Rico

Predictive Quality, Real-Time Release & Automation on the Plant Floor
Apr 20-21
Chicago, IL

Validation University

Process Validation & Equipment Qualification Across the Lifecycle, from the People Actually Doing It

May 11-12
San Francisco, CA

AI in GxP: Pilot to Production to Scale

Real Deployments. Real Validation. Real Scale.

Jun 2-3
San Diego, CA

GxP Laboratory Summit

Analytical Methods, Data Integrity & Lab Modernization, from the People Running the Labs

Jun 15-16
Dublin, Ireland

CSV & CSA European Congress

Getting Ready for the New Annex 11: Risk-Based CSV & CSA in Practice

Aug 10-11
Philadelphia, PA

Sterility Assurance University

Contamination Control That Holds Up to FDA: CCS, Microbiology & Cleaning Validation

Sep 28-29
Boston, MA

AI in GxP: Guardrails & Governance

Risk, Oversight, Model Monitoring, and Inspection Readiness for AI

Oct 13-14
RTP, NC

GCP & Clinical Operations Summit

Making E6(R3) Work: Quality by Design, Vendor Oversight & AI in Clinical Trials

Nov 3-4
Dallas, TX

GMP & Quality Operations Summit

Inspection Readiness, Warning Letter Lessons & New-Site Startup, from the Quality Teams Living It

Nov 16-17
Frankfurt, Germany

AI in GxP: Europe

Annex 22, Annex 11 & the EU AI Act, in the Heart of Europe’s Pharma Industry

Dec 8-9
Philadelphia, PA

CSV & CSA University

Less Paperwork, More Assurance: Making the Move from CSV to CSA

FAQ

Frequently asked questions

Still have a question? Book a call →

Who should attend?

This event is designed for validation, quality, and IT professionals in pharmaceutical, biotech, MedTech, CDMO, and CRO organizations.

No. CSV & CSA University is an in person only event in Philadelphia, PA on December 8–9, 2027.

Access to all sessions across both days, the exhibitor showroom, breakfast, lunch, networking refreshment breaks and the networking reception.

Yes. Registering 6 or more attendees? Use the group pricing form to request special group pricing.

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.

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.

AI in GxP: Europe

Special Rate $1,495
Get Tickets
Overview

Europe Is Writing the Rules for AI in GxP.

Annex 22 sets expectations for AI used in GMP, the revised Annex 11 updates computerised system requirements, and the EU AI Act adds obligations of its own. Each one matters on its own. Together, they define how AI gets deployed in Europe. This event connects them into one practical approach.

Built for Europe

Sessions walk through Annex 22, the revised Annex 11, and the EU AI Act side by side, with a focus on where they overlap and what they require in practice.

From the people doing it

You will hear from European manufacturers and sponsors who are deploying AI under these rules, and from experts close to how they are being interpreted and inspected.

Outcomes

What you'll leave with

Annex 22

What Annex 22 expects for AI in GMP: intended use, model selection, test data, performance criteria, and human oversight.

Annex 11

How the revised Annex 11 applies to the systems AI runs on, from supplier oversight to security and periodic review.

EU AI Act

Which GxP use cases may fall under the AI Act, what obligations follow, and how to align them with GMP requirements.

AI Governance

Building one governance framework that satisfies Annex 22, Annex 11, the AI Act, and FDA expectations.

Validating AI Models

Risk-based validation of machine learning and generative AI using GAMP 5 Second Edition and the GAMP AI guidance.

Inspection Readiness in the EU

How European inspectors are approaching AI and what documentation they expect to see.

Who should attend

Built for the People Who Have to Control AI.

  • VP, Director, and Head of Quality, Validation
  • AI, Automation, and Center of Excellence Leads
  • CSV and CSA Managers and Specialists
  • Qualified Persons and QA Managers
  • Regulatory and Compliance Leads
  • Digital Transformation and Innovation
  • Regulatory Affairs and Compliance
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 AI in GxP
Europe

Group pricing

This field is for validation purposes and should be left unchanged.
Full name(Required)

Tickets

From $1,395
Need approval to attend?

Download a justification letter

A ready-to-send letter for your manager with key sessions, takeaways and pricing.

Download letter (PDF)
Venue & Travel

Frankfurt, Germany

November 16–17, 2027 · In person only
Venue and hotel room block details will be announced.

★★★★★

"One of the most practical conferences on AI in GxP and Life Sciences I’ve attended. I walked away feeling that I gained new knowledge and actionable insights that I could put into practice at work the very next day."

Senior Team Lead
DSV A/S
★★★★★

"The speakers were extremely knowledgeable! I enjoyed every single topic that was discussed and the conference had my full attention!"

Senior Manager, QA
BioAgilytix
★★★★★

"This event really raised the awareness of the emerging trend of AI in the GxP space. I hope KENX does another one similar to this. The networking discussions really make the event come alive."

Director
Taiho Oncology
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

Mar 31-Apr 1
San Juan, PR

AI in GxP: Puerto Rico

Predictive Quality, Real-Time Release & Automation on the Plant Floor
Apr 20-21
Chicago, IL

Validation University

Process Validation & Equipment Qualification Across the Lifecycle, from the People Actually Doing It

May 11-12
San Francisco, CA

AI in GxP: Pilot to Production to Scale

Real Deployments. Real Validation. Real Scale.

Jun 2-3
San Diego, CA

GxP Laboratory Summit

Analytical Methods, Data Integrity & Lab Modernization, from the People Running the Labs

Jun 15-16
Dublin, Ireland

CSV & CSA European Congress

Getting Ready for the New Annex 11: Risk-Based CSV & CSA in Practice

Aug 10-11
Philadelphia, PA

Sterility Assurance University

Contamination Control That Holds Up to FDA: CCS, Microbiology & Cleaning Validation

Sep 28-29
Boston, MA

AI in GxP: Guardrails & Governance

Risk, Oversight, Model Monitoring, and Inspection Readiness for AI

Oct 13-14
RTP, NC

GCP & Clinical Operations Summit

Making E6(R3) Work: Quality by Design, Vendor Oversight & AI in Clinical Trials

Nov 3-4
Dallas, TX

GMP & Quality Operations Summit

Inspection Readiness, Warning Letter Lessons & New-Site Startup, from the Quality Teams Living It

Nov 16-17
Frankfurt, Germany

AI in GxP: Europe

Annex 22, Annex 11 & the EU AI Act, in the Heart of Europe’s Pharma Industry

Dec 8-9
Philadelphia, PA

CSV & CSA University

Less Paperwork, More Assurance: Making the Move from CSV to CSA

FAQ

Frequently asked questions

Still have a question? Book a call →

Who should attend?

Professionals in pharmaceutical, biotech, MedTech, CDMO, and CRO organizations who own, validate, govern, or approve AI in EU-regulated operations.

No. AI in GxP: Europe is an in person only event in Frankfurt, Germany on November 16–17, 2027.

Access to all sessions across both days, the exhibitor showroom, breakfast, lunch, networking refreshment breaks and the networking reception.

Yes. Registering 6 or more attendees? Use the group pricing form to request special group pricing.

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.

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.

GCP & Clinical Operations Summit

Special Rate $1,495
Get Tickets
Overview

E6(R3) Is Here. Now Make It Work.

ICH E6(R3) reframes GCP around quality by design, proportionate risk, and sponsor oversight. The guideline sets the principles. Implementing them across studies, CROs, sites, and technology vendors is the hard part.

Built for clinical operations

Sessions cover E6(R3) implementation, critical-to-quality factors, CRO and vendor oversight, centralized and risk-based monitoring, and validated use of AI and clinical technology.

From the people doing it

Speakers are clinical operations and clinical QA leaders from sponsors and CROs who are implementing E6(R3) now, sharing their processes and their inspection experience.

Outcomes

What you'll leave with

E6(R3) Implementation

Updating SOPs, training, and governance for E6(R3), and prioritizing what changes first.

Quality by Design

Identifying critical-to-quality factors and building quality into protocols before the first patient is enrolled.

CRO & Vendor Oversight

Sponsor accountability, oversight plans, KPIs, and audits that show you are in control of outsourced work.

Risk-Based Monitoring

Centralized monitoring, key risk indicators, and targeted on-site visits that improve data quality.

AI in Clinical Trials

Using AI for site selection, data review, and document workflows, and validating it for GCP use.

GCP Inspection Readiness

Preparing the TMF, sites, and vendors for FDA and EMA inspections under E6(R3).

Who should attend

Built for the People Who Have to Control AI.

  • Clinical QA Managers and GCP Auditors
  • Study and Trial Managers
  • Vendor Oversight Leads
  • Clinical Data and Systems Leads
  • Pharmacovigilance
  • Sites and SMOs
  • Biotech
  • MedTech
  • Vendor and Outsourcing Management
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 GCP & Clinical Operations Summit

Group pricing

This field is for validation purposes and should be left unchanged.
Full name(Required)

Tickets

From $1,395
Need approval to attend?

Download a justification letter

A ready-to-send letter for your manager with key sessions, takeaways and pricing.

Download letter (PDF)
Venue & Travel

RTP, NC

Oct 13-14, 2027 · In person only
Venue and hotel room block details will be announced.

★★★★★

"One of the most practical conferences on AI in GxP and Life Sciences I’ve attended. I walked away feeling that I gained new knowledge and actionable insights that I could put into practice at work the very next day."

Senior Team Lead
DSV A/S
★★★★★

"The speakers were extremely knowledgeable! I enjoyed every single topic that was discussed and the conference had my full attention!"

Senior Manager, QA
BioAgilytix
★★★★★

"This event really raised the awareness of the emerging trend of AI in the GxP space. I hope KENX does another one similar to this. The networking discussions really make the event come alive."

Director
Taiho Oncology
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

Mar 31-Apr 1
San Juan, PR

AI in GxP: Puerto Rico

Predictive Quality, Real-Time Release & Automation on the Plant Floor
Apr 20-21
Chicago, IL

Validation University

Process Validation & Equipment Qualification Across the Lifecycle, from the People Actually Doing It

May 11-12
San Francisco, CA

AI in GxP: Pilot to Production to Scale

Real Deployments. Real Validation. Real Scale.

Jun 2-3
San Diego, CA

GxP Laboratory Summit

Analytical Methods, Data Integrity & Lab Modernization, from the People Running the Labs

Jun 15-16
Dublin, Ireland

CSV & CSA European Congress

Getting Ready for the New Annex 11: Risk-Based CSV & CSA in Practice

Aug 10-11
Philadelphia, PA

Sterility Assurance University

Contamination Control That Holds Up to FDA: CCS, Microbiology & Cleaning Validation

Sep 28-29
Boston, MA

AI in GxP: Guardrails & Governance

Risk, Oversight, Model Monitoring, and Inspection Readiness for AI

Oct 13-14
RTP, NC

GCP & Clinical Operations Summit

Making E6(R3) Work: Quality by Design, Vendor Oversight & AI in Clinical Trials

Nov 3-4
Dallas, TX

GMP & Quality Operations Summit

Inspection Readiness, Warning Letter Lessons & New-Site Startup, from the Quality Teams Living It

Nov 16-17
Frankfurt, Germany

AI in GxP: Europe

Annex 22, Annex 11 & the EU AI Act, in the Heart of Europe’s Pharma Industry

Dec 8-9
Philadelphia, PA

CSV & CSA University

Less Paperwork, More Assurance: Making the Move from CSV to CSA

FAQ

Frequently asked questions

Still have a question? Book a call →

Who should attend?

This event is designed for clinical operations, clinical quality, and GCP compliance professionals in pharmaceutical, biotech, MedTech, and CRO organizations.

No. GCP & Clinical Operations Summit is an in person only event in RTP, NC on October 13–14, 2027.

Access to all sessions across both days, the exhibitor showroom, breakfast, lunch, networking refreshment breaks and the networking reception.

Yes. Registering 6 or more attendees? Use the group pricing form to request special group pricing.

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.

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.

AI in GxP: Guardrails & Governance

Special Rate $1,495
Get Tickets
Overview

Trust, but Verify. Then Document It.

AI is already influencing deviations, batch review, and document workflows. Governance has to keep pace. That means a risk framework, a validation approach for models that change, monitoring that catches drift, and evidence an inspector will accept.

Built for oversight

Every session addresses a control question: how to classify AI risk, how to validate a model, how to monitor it in use, who is accountable, and what to show an inspector.

From the people doing it

You will hear from quality and validation leaders who have built AI governance programs inside manufacturers and sponsors, and leave with frameworks you can adapt right away.

Outcomes

What you'll leave with

AI Risk Management

Classifying AI use cases by risk, setting intended use, and right-sizing controls for GxP impact.

Validating AI

Applying CSA, GAMP 5 Second Edition, and the GAMP AI guidance to machine learning and generative AI, including performance criteria and test sets.

Model Monitoring & Lifecycle

Detecting drift, managing retraining and change control, and deciding when a model needs to be revalidated.

Human Oversight & Accountability

Defining human-in-the-loop roles, decision rights, and the governance structure that owns AI risk.

Supplier & Third-Party AI

Qualifying vendors whose products embed AI and keeping oversight when the model isn't yours.

Inspection Readiness

What auditors and inspectors ask about AI today and how to document and defend AI-enabled processes.

Who should attend

Built for the People Who Have to Control AI.

  • AI Governance and Risk Leads
  • QA, Compliance, and Audit Managers
  • Regulatory Affairs and Compliance
  • VP, Director, and Head of Quality
  • Chief Digital, Data, and Information Officers
  • CSV and CSA Managers and Specialists
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 AI in GxP: Guardrails & Governance.

Group pricing

This field is for validation purposes and should be left unchanged.
Full name(Required)

Tickets

From $1,395
Need approval to attend?

Download a justification letter

A ready-to-send letter for your manager with key sessions, takeaways and pricing.

Download letter (PDF)
Venue & Travel

Boston, MA

Sep 28-29, 2027 · In person only
Venue and hotel room block details will be announced.

★★★★★

"One of the most practical conferences on AI in GxP and Life Sciences I’ve attended. I walked away feeling that I gained new knowledge and actionable insights that I could put into practice at work the very next day."

Senior Team Lead
DSV A/S
★★★★★

"The speakers were extremely knowledgeable! I enjoyed every single topic that was discussed and the conference had my full attention!"

Senior Manager, QA
BioAgilytix
★★★★★

"This event really raised the awareness of the emerging trend of AI in the GxP space. I hope KENX does another one similar to this. The networking discussions really make the event come alive."

Director
Taiho Oncology
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

Mar 31-Apr 1
San Juan, PR

AI in GxP: Puerto Rico

Predictive Quality, Real-Time Release & Automation on the Plant Floor
Apr 20-21
Chicago, IL

Validation University

Process Validation & Equipment Qualification Across the Lifecycle, from the People Actually Doing It

May 11-12
San Francisco, CA

AI in GxP: Pilot to Production to Scale

Real Deployments. Real Validation. Real Scale.

Jun 2-3
San Diego, CA

GxP Laboratory Summit

Analytical Methods, Data Integrity & Lab Modernization, from the People Running the Labs

Jun 15-16
Dublin, Ireland

CSV & CSA European Congress

Getting Ready for the New Annex 11: Risk-Based CSV & CSA in Practice

Aug 10-11
Philadelphia, PA

Sterility Assurance University

Contamination Control That Holds Up to FDA: CCS, Microbiology & Cleaning Validation

Sep 28-29
Boston, MA

AI in GxP: Guardrails & Governance

Risk, Oversight, Model Monitoring, and Inspection Readiness for AI

Oct 13-14
RTP, NC

GCP & Clinical Operations Summit

Making E6(R3) Work: Quality by Design, Vendor Oversight & AI in Clinical Trials

Nov 3-4
Dallas, TX

GMP & Quality Operations Summit

Inspection Readiness, Warning Letter Lessons & New-Site Startup, from the Quality Teams Living It

Nov 16-17
Frankfurt, Germany

AI in GxP: Europe

Annex 22, Annex 11 & the EU AI Act, in the Heart of Europe’s Pharma Industry

Dec 8-9
Philadelphia, PA

CSV & CSA University

Less Paperwork, More Assurance: Making the Move from CSV to CSA

FAQ

Frequently asked questions

Still have a question? Book a call →

Who should attend?

This event is designed for professionals in Pharmaceutical, Biotech, MedTech, CDMO, CRO

No. AI in GxP: Guardrails & Governance is an in person only event in Boston, MA on Sep 28-29, 2027.

Access to all sessions across both days, the exhibitor showroom, breakfast, lunch, networking refreshment breaks and the networking reception.

Yes. Registering 6 or more attendees? Use the group pricing form to request special group pricing.

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.

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.

Sterility Assurance University

Special Rate $1,495
Get Tickets
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

This field is for validation purposes and should be left unchanged.
Full name(Required)

Tickets

From $1,395
Need approval to attend?

Download a justification letter

A ready-to-send letter for your manager with key sessions, takeaways and pricing.

Download letter (PDF)
Venue & Travel

Philadelphia, PA

Aug 10-11, 2027 · In person only
Venue and hotel room block details will be announced.

★★★★★

"One of the most practical conferences on AI in GxP and Life Sciences I’ve attended. I walked away feeling that I gained new knowledge and actionable insights that I could put into practice at work the very next day."

Senior Team Lead
DSV A/S
★★★★★

"The speakers were extremely knowledgeable! I enjoyed every single topic that was discussed and the conference had my full attention!"

Senior Manager, QA
BioAgilytix
★★★★★

"This event really raised the awareness of the emerging trend of AI in the GxP space. I hope KENX does another one similar to this. The networking discussions really make the event come alive."

Director
Taiho Oncology
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

Mar 31-Apr 1
San Juan, PR

AI in GxP: Puerto Rico

Predictive Quality, Real-Time Release & Automation on the Plant Floor
Apr 20-21
Chicago, IL

Validation University

Process Validation & Equipment Qualification Across the Lifecycle, from the People Actually Doing It

May 11-12
San Francisco, CA

AI in GxP: Pilot to Production to Scale

Real Deployments. Real Validation. Real Scale.

Jun 2-3
San Diego, CA

GxP Laboratory Summit

Analytical Methods, Data Integrity & Lab Modernization, from the People Running the Labs

Jun 15-16
Dublin, Ireland

CSV & CSA European Congress

Getting Ready for the New Annex 11: Risk-Based CSV & CSA in Practice

Aug 10-11
Philadelphia, PA

Sterility Assurance University

Contamination Control That Holds Up to FDA: CCS, Microbiology & Cleaning Validation

Sep 28-29
Boston, MA

AI in GxP: Guardrails & Governance

Risk, Oversight, Model Monitoring, and Inspection Readiness for AI

Oct 13-14
RTP, NC

GCP & Clinical Operations Summit

Making E6(R3) Work: Quality by Design, Vendor Oversight & AI in Clinical Trials

Nov 3-4
Dallas, TX

GMP & Quality Operations Summit

Inspection Readiness, Warning Letter Lessons & New-Site Startup, from the Quality Teams Living It

Nov 16-17
Frankfurt, Germany

AI in GxP: Europe

Annex 22, Annex 11 & the EU AI Act, in the Heart of Europe’s Pharma Industry

Dec 8-9
Philadelphia, PA

CSV & CSA University

Less Paperwork, More Assurance: Making the Move from CSV to CSA

FAQ

Frequently asked questions

Still have a question? Book a call →

Who should attend?

This event is designed for professionals in Pharmaceutical, Biotech, MedTech, CDMO, Compounding and Outsourcing Facilities

No. Sterility Assurance University is an in person only event in Philadelphia, PA on Aug 10-11, 2027.

Access to all sessions across both days, the exhibitor showroom, breakfast, lunch, networking refreshment breaks and the networking reception.

Yes. Registering 6 or more attendees? Use the group pricing form to request special group pricing.

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.

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.

CSV & CSA European Congress

Special Rate $1,495
Get Tickets
Overview

The New Annex 11 Is Coming. Is Your Program Ready?

The revised Annex 11 raises expectations for computerised systems across their lifecycle, from supplier oversight and data integrity to security and periodic review. Readiness starts with a risk-based program. One that applies critical thinking, makes use of supplier documentation, and spends effort where the risk is.

Outcomes

What you'll leave with

Annex 11 Readiness

What changes in the revised Annex 11, where most programs have gaps, and how to plan a realistic path to compliance.

GAMP 5 Second Edition

Critical thinking, agile delivery, and the updated GAMP 5 framework applied to real system lifecycles.

CSA in Practice

Risk-based testing, unscripted and exploratory testing, and right-sized documentation that holds up to EU and FDA inspectors.

Cybersecurity

Security controls, access management, and incident response for GxP systems as regulators treat security as a data integrity issue.

Supplier & Cloud Oversight

Qualifying SaaS and cloud providers, using supplier documentation, and keeping control of systems you don't host.

Data Integrity & Audit Trails

Audit trail design and review, periodic review, and data governance across the system lifecycle.

Jun 15-16, 2027

Agenda Preview

  1. 7:15 – 8:15

    Registration & Continental Breakfast

  2. 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.
  3. 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.
  4. 9:45 – 10:10

    Networking Break · Exhibitor Showroom

  5. 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.
  6. 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.
Jun 15-16, 2027
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

  • Computer System Validation and CSA
  • Quality Assurance and Quality Systems
  • IT and Infrastructure
  • Data Integrity
  • Information Security
  • Regulatory Compliance
  • Laboratory and Manufacturing Systems
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 CSV & CSA European Congress.

Group pricing

This field is for validation purposes and should be left unchanged.
Full name(Required)

Tickets

From $1,395
Need approval to attend?

Download a justification letter

A ready-to-send letter for your manager with key sessions, takeaways and pricing.

Download letter (PDF)
Venue & Travel

Dublin

June 15–16, 2027 · In person only
Venue and hotel room block details will be announced.

★★★★★

"One of the most practical conferences on AI in GxP and Life Sciences I’ve attended. I walked away feeling that I gained new knowledge and actionable insights that I could put into practice at work the very next day."

Senior Team Lead
DSV A/S
★★★★★

"The speakers were extremely knowledgeable! I enjoyed every single topic that was discussed and the conference had my full attention!"

Senior Manager, QA
BioAgilytix
★★★★★

"This event really raised the awareness of the emerging trend of AI in the GxP space. I hope KENX does another one similar to this. The networking discussions really make the event come alive."

Director
Taiho Oncology
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

Mar 31-Apr 1
San Juan, PR

AI in GxP: Puerto Rico

Predictive Quality, Real-Time Release & Automation on the Plant Floor
Apr 20-21
Chicago, IL

Validation University

Process Validation & Equipment Qualification Across the Lifecycle, from the People Actually Doing It

May 11-12
San Francisco, CA

AI in GxP: Pilot to Production to Scale

Real Deployments. Real Validation. Real Scale.

Jun 2-3
San Diego, CA

GxP Laboratory Summit

Analytical Methods, Data Integrity & Lab Modernization, from the People Running the Labs

Jun 15-16
Dublin, Ireland

CSV & CSA European Congress

Getting Ready for the New Annex 11: Risk-Based CSV & CSA in Practice

Aug 10-11
Philadelphia, PA

Sterility Assurance University

Contamination Control That Holds Up to FDA: CCS, Microbiology & Cleaning Validation

Sep 28-29
Boston, MA

AI in GxP: Guardrails & Governance

Risk, Oversight, Model Monitoring, and Inspection Readiness for AI

Oct 13-14
RTP, NC

GCP & Clinical Operations Summit

Making E6(R3) Work: Quality by Design, Vendor Oversight & AI in Clinical Trials

Nov 3-4
Dallas, TX

GMP & Quality Operations Summit

Inspection Readiness, Warning Letter Lessons & New-Site Startup, from the Quality Teams Living It

Nov 16-17
Frankfurt, Germany

AI in GxP: Europe

Annex 22, Annex 11 & the EU AI Act, in the Heart of Europe’s Pharma Industry

Dec 8-9
Philadelphia, PA

CSV & CSA University

Less Paperwork, More Assurance: Making the Move from CSV to CSA

FAQ

Frequently asked questions

Still have a question? Book a call →

Who should attend?

This event is designed for validation, quality, and IT professionals in pharmaceutical, biotech, MedTech, CDMO, and CRO organizations operating under EU GMP.

No. CSV & CSA European Congress is an in person only event in Dublin, Ireland on June 15–16, 2027.

Access to all sessions across both days, the exhibitor showroom, breakfast, lunch, networking refreshment breaks and the networking reception.

Yes. Registering 6 or more attendees? Use the group pricing form to request special group pricing.

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.

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.

AI in GxP: Governance, Validation, and Inspection Readiness (Recording)

This recording is restricted

Enter your access code to watch.

GxP Laboratory Summit

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.

Analytical, stability, and data integrity

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.

From the people running the labs

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.

The life of a lab result

Every Step Is an
Inspection Point.

Follow a result from sample to release, and where data integrity risk shows up along the way.

01 →

Sample

Receipt, chain of custody, and storage.

Where it goes wrong Where it goes wrong
02 →

Method

A validated, fit-for-purpose analytical procedure.

Where it goes wrong Where it goes wrong
03 →

Data

Acquisition in CDS, LIMS, and connected instruments.

Where it goes wrong Where it goes wrong
04 →

Review

Second-person review of data and audit trails.

Where it goes wrong Where it goes wrong
05

Release

A result the quality unit can stand behind.

Where it goes wrong Where it goes wrong

What You'll Take Home.

Six themes across analytical quality, stability, and data integrity.

01

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.

02

Stability Testing &
Program Management

Designing stability-indicating methods, meeting ICH, FDA, and EU expectations, and moving stability programs beyond spreadsheets and silos.

03

Predictive Stability
& Real-Time Release

Using predictive modeling, accelerated and stress testing, and modern analytics to forecast shelf life and rethink traditional stability approaches.

04

OOS, OOT &
OOE Investigations

Advanced case studies on finding true root causes in QC and stability programs, and preventing recurrence through robust data evaluation.

05

Data Integrity by Design

Building integrated digital controls, audit trail review, and quality risk management into analytical operations from the start.

06

AI & Lab Modernization

AI and machine learning in method optimization and data review, digital method development, and the LIMS, ELN, and automation behind them.

2027 Agenda

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.

02 Day OneWed, June 2027
03 Day TwoThu, June 2027

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.

1

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.

2

Case Studies with
the Details Left In

Hear what worked, what failed, how long it took, and what the documentation actually looked like.

3

Small Enough to
Talk to Everyone

A focused, in person audience means real conversations with speakers and peers, not a sea of badges.

4

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.

5

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.”

Past KENX attendee
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

This field is for validation purposes and should be left unchanged.
Full name(Required)

GxP Laboratory Summit

June 2–3, 2027 · San Diego, CA · In person only

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

Mar 31-Apr 1
San Juan, PR

AI in GxP: Puerto Rico

Predictive Quality, Real-Time Release & Automation on the Plant Floor
Apr 20-21
Chicago, IL

Validation University

Process Validation & Equipment Qualification Across the Lifecycle, from the People Actually Doing It

May 11-12
San Francisco, CA

AI in GxP: Pilot to Production to Scale

Real Deployments. Real Validation. Real Scale.

Jun 2-3
San Diego, CA

GxP Laboratory Summit

Analytical Methods, Data Integrity & Lab Modernization, from the People Running the Labs

Jun 15-16
Dublin, Ireland

CSV & CSA European Congress

Getting Ready for the New Annex 11: Risk-Based CSV & CSA in Practice

Aug 10-11
Philadelphia, PA

Sterility Assurance University

Contamination Control That Holds Up to FDA: CCS, Microbiology & Cleaning Validation

Sep 28-29
Boston, MA

AI in GxP: Guardrails & Governance

Risk, Oversight, Model Monitoring, and Inspection Readiness for AI

Oct 13-14
RTP, NC

GCP & Clinical Operations Summit

Making E6(R3) Work: Quality by Design, Vendor Oversight & AI in Clinical Trials

Nov 3-4
Dallas, TX

GMP & Quality Operations Summit

Inspection Readiness, Warning Letter Lessons & New-Site Startup, from the Quality Teams Living It

Nov 16-17
Frankfurt, Germany

AI in GxP: Europe

Annex 22, Annex 11 & the EU AI Act, in the Heart of Europe’s Pharma Industry

Dec 8-9
Philadelphia, PA

CSV & CSA University

Less Paperwork, More Assurance: Making the Move from CSV to CSA

FAQ

Frequently asked questions

Still have a question? Book a call →

Who should attend?

This event is designed for analytical, QC, stability, and quality professionals in pharmaceutical, biotech, MedTech, CDMO, and contract testing organizations.

No. GxP Laboratory Summit is an in person only event in San Diego, CA on June 2–3, 2027.

Access to all sessions across both days, the exhibitor showroom, breakfast, lunch, networking refreshment breaks and the networking reception.

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.

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.

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.

AI in GxP: Pilot to Production to Scale

Special Rate $1,495
Get Tickets
Overview

From Proof of Concept to Proof of Value.

Most life sciences companies have run AI pilots. Far fewer have moved them into validated, production GxP use. The gap is rarely the technology. It’s validation strategy, data readiness, change management, and the confidence to stand behind an AI system during an inspection.

Built for the gap

AI in GxP: Pilot to Production to Scale is built for that gap. This isn’t a conference about what AI might do someday. Every session centers on real implementations: what was deployed, how it was validated, what broke, and what it took to scale from one site or one use case to many.

From the people doing it

You’ll hear directly from manufacturers who have taken AI into validated production across quality, manufacturing and the laboratory, and you’ll leave with frameworks you can apply the following week.

Program

What the Program Covers.

AI in Quality Operations

AI agents in the deviation workflow, batch record review, GMP document drafting and QC data review: AI applied to the quality work that eats the most hours.

Validating AI Under GMP

Applying CSA and the GAMP AI guidance, setting acceptance criteria before go-live, and keeping models validated once they’re live.

AI on the Manufacturing Floor

Vision inspection, process models on continuous lines and predictive maintenance, qualified for commercial production.

Scaling Across the Network

Platform qualification, reusable validation packages, tech transfer to sites and CDMOs, and the data and funding that make scale possible.

Leadership & Adoption

Why pilots stall, how leaders get them into production, and how to bring operators and QA reviewers along.

OUR COMMUNITY

Past Attendees Include

May 11-12, 2027

Agenda Preview

  1. 7:15 – 8:15

    Registration & Continental Breakfast

  2. 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.
  3. 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.
  4. 9:45 – 10:10

    Networking Break · Exhibitor Showroom

  5. 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.
  6. 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.
May 11-12, 2027
Who should attend

Built for the people who have to make AI work, and sign off on it, in a GMP environment

  • Validation, CSV & CSA leaders
  • Quality assurance & compliance
  • QC & laboratory leaders
  • Manufacturing, MS&T & engineering
  • Digital, data science & IT quality
  • Regulatory affairs & data integrity
  • Site heads & operations leaders
  • AI program & CoE leads
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 AI in GxP: Pilot to Production to Scale.

Group pricing

This field is for validation purposes and should be left unchanged.
Full name(Required)

Tickets

From $1,395
Need approval to attend?

Download a justification letter

A ready-to-send letter for your manager with key sessions, takeaways and pricing.

Download letter (PDF)
Venue & Travel

San Francisco.

May 11–12, 2027 · In person only
Venue and hotel room block details will be announced.

★★★★★

"One of the most practical conferences on AI in GxP and Life Sciences I’ve attended. I walked away feeling that I gained new knowledge and actionable insights that I could put into practice at work the very next day."

Senior Team Lead
DSV A/S
★★★★★

"The speakers were extremely knowledgeable! I enjoyed every single topic that was discussed and the conference had my full attention!"

Senior Manager, QA
BioAgilytix
★★★★★

"This event really raised the awareness of the emerging trend of AI in the GxP space. I hope KENX does another one similar to this. The networking discussions really make the event come alive."

Director
Taiho Oncology
Two Days in the Room

Scenes from past KENX AI in GxP conferences.

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

Mar 31-Apr 1
San Juan, PR

AI in GxP: Puerto Rico

Predictive Quality, Real-Time Release & Automation on the Plant Floor
Apr 20-21
Chicago, IL

Validation University

Process Validation & Equipment Qualification Across the Lifecycle, from the People Actually Doing It

May 11-12
San Francisco, CA

AI in GxP: Pilot to Production to Scale

Real Deployments. Real Validation. Real Scale.

Jun 2-3
San Diego, CA

GxP Laboratory Summit

Analytical Methods, Data Integrity & Lab Modernization, from the People Running the Labs

Jun 15-16
Dublin, Ireland

CSV & CSA European Congress

Getting Ready for the New Annex 11: Risk-Based CSV & CSA in Practice

Aug 10-11
Philadelphia, PA

Sterility Assurance University

Contamination Control That Holds Up to FDA: CCS, Microbiology & Cleaning Validation

Sep 28-29
Boston, MA

AI in GxP: Guardrails & Governance

Risk, Oversight, Model Monitoring, and Inspection Readiness for AI

Oct 13-14
RTP, NC

GCP & Clinical Operations Summit

Making E6(R3) Work: Quality by Design, Vendor Oversight & AI in Clinical Trials

Nov 3-4
Dallas, TX

GMP & Quality Operations Summit

Inspection Readiness, Warning Letter Lessons & New-Site Startup, from the Quality Teams Living It

Nov 16-17
Frankfurt, Germany

AI in GxP: Europe

Annex 22, Annex 11 & the EU AI Act, in the Heart of Europe’s Pharma Industry

Dec 8-9
Philadelphia, PA

CSV & CSA University

Less Paperwork, More Assurance: Making the Move from CSV to CSA

FAQ

Frequently asked questions

Still have a question? Book a call →

Who should attend?

Professionals in pharmaceutical, biotech, MedTech and CDMO organizations who deploy, validate, scale or approve AI in GMP operations.

No. AI in GxP: Pilot to Production to Scale is an in person only event in San Francisco, CA on May 11-12, 2027.

Access to all sessions across both days, the exhibitor showroom, presentation slides, session recordings, templates & checklists, and a certificate of attendance, plus breakfast, lunch, networking refreshment breaks and the networking reception.

Yes. Registering 6 or more attendees? Use the group pricing form to request special group pricing.

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.

Use the Become a Sponsor link, or complete our sponsorship inquiry form at kenx.org/sponsorship-inquiry, and the KENX team will follow up with options.

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.