Computer Systems, Software & AI Validation University Europe

COMPUTER SYSTEMS, SOFTWARE & AI VALIDATION UNIVERSITY EUROPE

Modernizing Approaches Across Legacy, Cloud, and AI-Driven GxP Systems

Attend ViRtually or In-Person

Top 10 Challenges VALIDATION AND COMPLIANCE PROFESSIONALS are solving in 2026

Platinum

Gold Sponsors

Overview

CSV & CSA University brings together experts across validation, quality, IT, and digital systems for two days of practical, implementation-focused training. The program emphasizes modern, risk-based approaches aligned with global expectations, including EU Annex 11, the emerging Annex 22 draft, and contemporary CSA principles for streamlining computerized system assurance. As organizations manage a mix of legacy platforms, cloud solutions, and AI-enabled technologies, attendees will gain real-world strategies, templates, and examples to strengthen compliance while modernizing validation practices across today’s evolving GxP landscape.

What You’ll Learn

How to operate CSA while maintaining compliance across validation, quality, and IT
Modern risk-based approaches that reduce documentation burden and accelerate system readiness
Best practices for vendor audits, upgrades, SaaS/Cloud validation, mobile apps, automation, and digital systems
Where emerging digital and AI capabilities fit into CSV/CSA frameworks, including governance, guardrails, and human-in-the-loop

Special Features

Case studies from pharma, biotech, medical device, and digital health teams
Step-by-step walk-throughs of templates, checklists, test scripts, and risk tools
Sessions covering Data Integrity, audit trails, cybersecurity, and evolving regulatory expectations
Two-track format to tailor learning across CSV fundamentals, CSA innovation, and AI-enabled approaches

Who Should Attend

Validation, Quality, and Compliance Professionals
IT, Automation, and Digital Transformation Leaders
CSV/CSA Specialists, System Owners, and Project Managers
QA Documentation, Data Integrity, and Audit Trail Review Teams
R&D, Manufacturing, Process Development, and GxP Operations
Anyone responsible for implementing or overseeing GxP computerized systems

★★★★★

The CSA/CSV University Conference was a great experience, there is a large range of topics discussed that I found to increase my own knowledge, but also gave me insights on how I can handle tasks at my current employment. There is a lot of insights into how to leverage AI to reduce costs, time and effort, and increase productivity for companies. As a younger professional (<5 years of experience), I would recommend attending this event.

★★★★★

I very much enjoyed the KENX CSV & CSA University. I attended virtually, and it was well worth the time and resources spent. Look forward to attending in the future!

★★★★★

Kenx conferences give you an opportunity to meet with industry leaders in a smaller environment, enhancing the networking opportunities. The topics are timely, targeted, and focused and I have been able to apply what I have learned immediately upon returning to the office.

Faculty

Anant Agrawal

Susan B. Cleary

Stephen J Cook

Dr. Steven Davy

Joanne Goldberg

Dori Gonzalez-Acevedo

John Harrington

Philip Jarvis

Loganathan Kumarasamy

AnnaMaria Lambidis

Ray Murphy

Stefan Münch

Donncadh J. Nagle

Andy O’Connor

Dr. Kevin O’Donnell

Ben O’Brien

Raul Soto

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.

Pharmaceutical Engineering Summit

PHARMACEUTICAL ENGINEERING SUMMIT

Integrating Process, Automation, and Facility Excellence

Attend ViRtually or In-Person

Top 10 Engineering Challenges & How Pharma Leaders Are Solving Them in 2026

Platinum

Gold Sponsors

Overview

Engineering and validation are converging and the Pharmaceutical Engineering Summit 2026 is where that integration takes shape. This focused program brings together process, automation, and facility engineers to share best practices in designing, commissioning, and qualifying modern GxP environments. From Automation Lifecycle Qualification (ALQ) to Utilities 4.0, predictive maintenance, and AI-driven facility monitoring, discover how engineering excellence drives compliance, sustainability, and operational performance.

What You’ll Learn

Engineer data-ready, flexible facilities that support digital validation and CQV 4.0
Implement Automation Lifecycle Qualification (ALQ) using CSA and risk principles
Perform Design Qualification (DQ) with BIM modeling and digital twins
Embed AI and IoT monitoring into utilities, HVAC, and water systems Build predictive
Maintenance programs for inspection-ready reliability
Integrate data integrity controls across automation and building systems
Streamline handover from engineering to quality using digital records
Apply risk-based commissioning and qualification for efficient resource use

Special Features

One concentrated track of engineering-driven case studies and workshops
Deep dives into Utilities 4.0, DQ, ALQ, and automation integration
Exclusive AI in Facilities & Predictive Maintenance module
Panel on Engineering for Compliance 4.0 exploring design and regulatory alignment
Collaboration sessions bridging Validation and Engineering disciplines

Who Should Attend

Professionals involved in engineering, design, and automation within regulated environments, including:

Co-Located with Validation University

Validation is evolving fast — and Validation University equips life-science professionals to stay ahead. From lifecycle-based process validation to AI-driven testing, digital twins, and CSA implementation, this two-track program unites experts in quality, validation, engineering, and IT to share practical, risk-based strategies. Whether your focus is process and cleaning validation or CSV/CSA and facility qualification, every session delivers tangible insights aligned with the latest FDA and EU expectations.

★★★★★

Great event! Very well ran with a good standard of speakers, would recommend to others to attend to expand their knowledge and understanding of trending industry topics

Automation Engineering Manager

★★★★★

I was very happy with the topics covered and the calibre of speaker at the event.

Quality Engineering Manager

★★★★★

The event was well organized, the relevance and quality of the speakers and presentations were excellent. I appreciated how speakers did deep dives on subjects rather than just high level overviews. I would strongly recommend to anyone who is interested in going for more detailed and indepth knowledge sharing.

Operations Manager

Faculty

Ahmed Al-Shehab

Chip Bennett

Sumeer Bhargava

Jorge Cordero-Monroig

Dori Gonzalez-Acevedo

AnnaMaria Lambidis

Dawn Marshall

Gianna Petrongolo

Sneha Saggurthi

David W. Vincent

Gaurav Walia

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.

Laboratory University 2026

Analytical Quality & Control

Stability Testing & Program Management

Laboratory University

Top 10 Challenges LABORATORY LEADERS are solving IN 2026

Gold Sponsors

Overview

Analytical and stability excellence form the cornerstone of product quality and Laboratory University 2026 unites both under one comprehensive program. With two full tracks – Analytical Procedures & QC Excellence and Stability Testing Program Management – this event delivers deep technical training, regulatory insight, and practical solutions for life-science laboratories. From ICH Q2(R2)/Q14 analytical lifecycle management to trending, data integrity, and global stability programs, every session offers actionable strategies aligned with FDA, EMA, and ICH expectations. Attendees will gain the tools to modernize laboratory operations, validate and transfer methods efficiently, and maintain compliant stability programs that stand up to inspection.

What You’ll Learn

Analytical Procedures & QC Excellence
Apply lifecycle-based analytical validation and transfer strategies aligned with ICH Q2(R2)/Q14 guidance
Implement robust method performance verification and analytical change control programs
Strengthen QC systems through data integrity, automation, and digital review processes
Leverage AI and analytics for trend detection, OOT/OOS evaluation, and predictive quality
Integrate analytical and process validation data for seamless lifecycle control
Optimize documentation and readiness for regulatory inspection and audit

Stability Testing Program Management

Design, execute, and trend stability studies to ensure product shelf-life and regulatory compliance
Develop statistically sound protocols for accelerated, long-term, and on-going studies
Interpret trending data to detect early degradation signals and drive proactive decision-making
Integrate stability programs within digital and paperless quality systems
Manage stability changes and investigations with risk-based decision tools
Harmonize stability documentation across global markets and post-approval programs

Special Features

More than 40 sessions across two dedicated tracks: Analytical & QC Excellence and Stability Testing University
Hands-on workshops for analytical lifecycle management, trending, and data integrity review
Comprehensive stability modules featuring real-world implementation of ICH Q1 and Q2(R2)/Q14
Case studies demonstrating digital transformation and automation in laboratory operations
Cross-functional panels connecting analytical, validation, and QA leaders for lifecycle collaboration
Templates, checklists, and case examples for method validation, trending, and stability protocols

Who Should Attend

Analytical Scientists and Chemists
QC and QA Managers
Method Validation and Transfer Specialists
Stability and CMC Professionals
Laboratory and Compliance Managers
Data Integrity and Automation Leads
Regulatory Affairs and Quality Systems Experts

Co-Located with GxP Supply Chain Summit

Broaden your perspective by attending the GxP Supply Chain Summit – a companion program exploring sourcing, serialization, packaging, and distribution excellence. Together, these programs provide an integrated view of quality, from analytical testing and stability through global supply chain execution.

★★★★★

The KENX AI in GXP conference was very informative, thought provoking, and cutting edge.

★★★★★

This event was amazing. Every presentation and connection left me with a wealth of knowledge.

★★★★★

This was a very useful conference with excellent speakers.

★★★★★

Excellent course/seminar with great speakers.

★★★★★

KENX Conferences are amazing with great topics, detailed discussion and great speaker, attendee and sponsor engagement.

GxP SUPPLY CHAIN SUMMIT 2026

GXP SUPPLY CHAIN SUMMIT

From Sourcing to Serialization: Advancing Quality, Resilience, and AI-Enabled Transformation

Top 10 Challenges GxP SUPPLY CHAIN LEADERS are solving IN 2026

Gold Sponsors

Overview

From sourcing to serialization, today’s regulated supply chains require transparency, intelligence, and resilience. The GxP Supply Chain Summit 2026 brings together leaders in quality, logistics, packaging, and procurement to tackle the complex challenges of global operations. Explore how AI, automation, and digital quality systems are redefining compliance, supplier oversight, and end-to-end product traceability. Attendees will gain the tools to enhance visibility, reduce risk, and strengthen alignment with evolving FDA, EMA, and international GxP standards.

What You’ll Learn

Develop and execute supplier qualification and management programs built on risk-based principles
Strengthen serialization, labeling, and traceability systems to prevent counterfeiting and ensure compliance
Integrate QMS, ERP, and MES data for unified supply chain visibility
Implement digital and AI-enabled solutions to predict risk and improve performance
Manage change control and document flow across global suppliers and CMOs
Leverage predictive analytics to optimize inventory, logistics, and quality oversight
Apply audit trail and data integrity practices throughout supplier and manufacturing networks
Align operations with Annex 21 and other international supply chain regulatory frameworks

Special Features

More than 30 expert-led sessions covering sourcing, packaging, serialization, and digital transformation
Hands-on workshops for supplier audits, risk mapping, and global logistics management
Dedicated sessions on AI and predictive quality across supply chain operations
Panels connecting QA, Procurement, IT, and Manufacturing leaders for holistic oversight
Case studies from pharma, biotech, and MedTech companies demonstrating best-in-class models
Practical tools and templates for supplier qualification, packaging validation, and traceability
Networking opportunities with regulators, industry experts, and solution providers

Who Should Attend

Supply Chain and Procurement Managers
Quality Assurance and Regulatory Specialists
Packaging, Labeling, and Serialization Experts
Operations and Manufacturing Professionals
Validation and Supplier Quality Engineers
Digital Transformation and Data Analytics Leads
Global Compliance and Risk Managers

Co-Located with Laboratory University

Held alongside Laboratory University, which offers participants expanded learning and networking opportunities across analytical methods, QC, stability testing, and supply chain operations.

★★★★★

The KENX AI in GXP conference was very informative, thought provoking, and cutting edge.

★★★★★

This event was amazing. Every presentation and connection left me with a wealth of knowledge.

★★★★★

This was a very useful conference with excellent speakers.

★★★★★

Excellent course/seminar with great speakers.

★★★★★

KENX Conferences are amazing with great topics, detailed discussion and great speaker, attendee and sponsor engagement.

Faculty

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.

Validation University

8th Annual
VALIDATION UNIVERSITY

Driving Excellence in the Next Era of Validation & Qualification Processes

Attend ViRtually or In-Person

Top 10 Validation Challenges Life Sciences Teams Are Solving in 2026

Platinum

Gold Sponsors

Overview

Validation is evolving fast — and Validation University equips life-science professionals to stay ahead. From lifecycle-based process validation to AI-driven testing, digital twins, and CSA implementation, this two-track program unites experts in quality, validation, engineering, and IT to share practical, risk-based strategies. Whether your focus is process and cleaning validation or CSV/CSA and facility qualification, every session delivers tangible insights aligned with the latest FDA and EU expectations.

What You’ll Learn

Apply Computer Software Assurance (CSA) across systems, software, and documentation
Implement controls aligned with QMSR and ISO 13485 ahead of 2026 enforcement
Validate AI and adaptive software under the FDA’s final AI/ML guidance
Build audit-ready documentation for cybersecurity, cloud platforms, and SBOMs
Prepare for EU MDR/IVDR transitions and notified body expectations
Translate real-world evidence (RWE) into regulatory submissions
Comply with new LDT regulation beginning May 2025
Connect design control, usability, and risk for stronger submissions
Leverage supplier oversight dashboards and remote audit strategies
Align your Part 11 compliance for modern, cloud-based environments

Special Features

45 + focused sessions across Process, Cleaning, CSV/CSA, Facility & Equipment
Dedicated AI in Validation sessions featuring real-world use cases and emerging frameworks
Hands-on workshops for paperless validation and CSA scaling
Cross-disciplinary panels linking validation, engineering, and automation strategy
Practical statistics and risk-based workshops to reduce cost and complexity

Who Should Attend

Professionals responsible for ensuring compliant, efficient validation programs, including:

Validation Engineers and Managers
QA/QC Specialists and Leads
Process Development and Manufacturing Engineers
CSV/CSA Leads and IT Quality Professionals
Facility and Equipment Qualification Managers
Regulatory Affairs and Compliance Officers
Data Integrity and Digital Transformation Specialists

Co-Located with Pharmaceutical Engineering Summit 2026

Engineering and validation are converging and the Pharmaceutical Engineering Summit 2026 is where that integration takes shape. This focused program brings together process, automation, and facility engineers to share best practices in designing, commissioning, and qualifying modern GxP environments. From Automation Lifecycle Qualification (ALQ) to Utilities 4.0, predictive maintenance, and AI-driven facility monitoring, discover how engineering excellence drives compliance, sustainability, and operational performance.

★★★★★

Great event that brings Industry and regulators together!

Senior Manager, Validation

★★★★★

Very well organized and topics were of high interest. One event that I truly enjoyed from beginning to end.

Quality Control Manager

★★★★★

Very well organized. Excellent Agenda and Compendium.

IT Quality Manager

Faculty

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.

COMPUTER SYSTEMS, SOFTWARE & AI VALIDATION UNIVERSITY EUROPE

Modernizing Approaches Across Legacy, Cloud, and AI-Driven GxP Systems

Top 10 Challenges VALIDATION AND COMPLIANCE PROFESSIONALS are solving in 2026

Gold Sponsors

Overview

What You’ll Learn

Special Features

Who Should Attend

VENUE

PHARMACEUTICAL ENGINEERING SUMMIT

Integrating Process, Automation, and Facility Excellence

Top 10 Engineering Challenges & How Pharma Leaders Are Solving Them in 2026

Gold Sponsors

Overview

What You’ll Learn

Special Features

Who Should Attend

Co-Located with Validation University

VENUE

Analytical Quality & Control

Stability Testing & Program Management

Laboratory University

Top 10 Challenges LABORATORY LEADERS are solving IN 2026

Gold Sponsors

Overview

What You’ll Learn

Stability Testing Program Management

Special Features

Who Should Attend

Co-Located with GxP Supply Chain Summit

VENUE

GXP SUPPLY CHAIN SUMMIT

From Sourcing to Serialization: Advancing Quality, Resilience, and AI-Enabled Transformation

Top 10 Challenges GxP SUPPLY CHAIN LEADERS are solving IN 2026

Gold Sponsors

Overview

What You’ll Learn

Special Features

Who Should Attend

Co-Located with Laboratory University

VENUE

8th AnnualVALIDATION UNIVERSITY

Driving Excellence in the Next Era of Validation & Qualification Processes

Top 10 Validation Challenges Life Sciences Teams Are Solving in 2026

Gold Sponsors

Overview

What You’ll Learn

Special Features

Who Should Attend

Co-Located with Pharmaceutical Engineering Summit 2026

VENUE

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8th Annual
VALIDATION UNIVERSITY