Building a Validation Center of Excellence: Lessons and Practical Insight

Building a Validation Center of Excellence: Lessons and Practical Insight

DateNovember 4, 2026
Time11:00 AM ET
CostFree, and recorded
What you'll take away
  • Understand key considerations for establishing and structuring a Validation CoE to promote consistent, compliant validation practices across the organization
  • Learn from real-world experiences and challenges, including lessons learned while implementing and operating a Validation CoE.
  • Explore ways to improve efficiency and consistency across validation activities while maintaining strong regulatory compliance.
  • Discover approaches for continuous improvement and sustaining an effective Validation CoE over the long term.

Save your seat

Free to attend. Can't join live? Register and we'll send the recording.

Building an Effective Validation CoE

Establishing a Validation Center of Excellence (CoE) can help organizations strengthen compliance, improve consistency, and drive greater efficiency across their validation activities. But what does it take to build and sustain an effective CoE and what can organizations learn from practical experience?

The conversation will cover key considerations for establishing and operating a Validation CoE, lessons learned along the way, common challenges, and approaches to driving consistency, efficiency, and continuous improvement while maintaining a strong compliance focus.

Whether you are considering establishing a Validation CoE or looking to strengthen an existing model, this session will offer practical insights to inform your approach.

Sponsored by

Join us for an interactive, Q&A-style discussion with Geetanjali (Geetu) Abbi, Senior Director, Digital Quality Assurance at Alkermes, alongside Vignesh Srinivas, Head of Digital Compliance Assurance at Zifo, as we explore the role and value of a Validation CoE.

Built for

Who should attend.

Built for the people who have to validate, govern, and defend AI-enabled clinical systems.

CSV / CSA IT Quality Digital Quality Assurance Validation & Compliance Clinical Systems Quality Assurance Clinical Quality Assurance Regulatory Affairs GxP Compliance Quality & Compliance Leaders
The panel

Who you'll hear from.

A panel of practitioners who live inside these questions, moderated live with audience Q&A.

Speaker
Vignesh Srinivas
Head- Digital Compliance Assurance
Zifo
Speaker
Geetanjali (Geetu) Abbi
Senior Director, Digital Quality Assurance
Alkermes

AI in GxP: Governance, Validation, and Inspection Readiness

Seats are limited. Registration closes as soon as capacity is reached.

KENX VIRTUAL TRAINING  ·  HALF DAY  ·  LIVE ONLINE

AI in GxP: Governance, Validation, and Inspection Readiness

Four focused hours on what regulators now expect from AI-enabled systems, and how to build governance and validation evidence that holds up in an inspection.

DATE
Wednesday, October 28, 2026
TIME
12:00 – 4:00 PM ET
TUITION
$495 per seat
Reserve your seat View full agenda

Bringing your team? Contact info@kenx.org to ask about our team discount.

Seats are limited to keep the session interactive.

Why this training, and why now

The regulatory ground under AI in regulated environments moved fast. Quality and validation teams are being asked for governance, evidence, and answers they were never asked for before.

JAN 2025

FDA draft guidance sets a risk-based credibility framework for AI supporting regulatory decisions on safety, efficacy, and quality.

JAN 2026

Joint FDA and EMA principles extend that thinking across the full medicines lifecycle, from research to post-market.

APR 2026

FDA issues its first warning letter explicitly citing AI misuse as a GxP compliance violation in pharmaceutical manufacturing.

EU AI ACT

AI in medical devices and critical health infrastructure is classified high risk, adding a binding layer alongside GxP.

The four hours

Built from the sessions that drew the most discussion at the KENX AI in GxP conference series, condensed into a working curriculum.

MODULE ONE
12:00 – 12:50

What Regulators Now Expect

The current landscape in plain terms: FDA guidance, FDA and EMA joint principles, Annex 11 and 22 direction, and the EU AI Act. What enforcement so far tells you about where inspectors will look first.

MODULE TWO
12:55 – 1:45

Governance and Intended Use

Establishing intended use as your governance anchor. Classifying AI systems by risk and context of use, defining ownership and escalation paths across IT, QA, and the business, and building an AI system inventory that survives scrutiny.

MODULE THREE
1:55 – 2:45

Validating AI-Enabled Systems

Writing acceptance criteria for systems that do not behave deterministically. Making intelligent systems testable and defensible, qualifying SaaS and IaaS platforms underneath them, and assessing third-party and supplier risk.

MODULE FOUR
2:50 – 4:00

10 Steps to Achieving AI Regulatory Compliance

Presented on the ten steps to achieving AI regulatory compliance: from AI inventory and risk classification through to the controls and documentation regulators expect to see.

View the full agenda

What you leave with

Every attendee receives a working toolkit, not just slides.

  • An AI system inventory and risk classification template
  • An intended use statement template with worked examples
  • An acceptance criteria checklist for AI-enabled validation
  • A governance responsibility matrix you can adapt internally
  • An inspection question set to run against your own program
  • Access to the session recording for later review

Who should be in the room

Written for practitioners and the leaders who have to sign off on their work. No coding or data science background required.

  • Validation and CSV/CSA professionals
  • Quality assurance and compliance leaders
  • GxP IT and enterprise systems quality
  • Regulatory affairs and data integrity roles
  • Manufacturing and laboratory quality
  • Teams preparing a first GxP AI pilot

Your faculty

Quality, IT and regulatory leaders from regulated manufacturers, teaching the material they presented on stage. No vendor pitches.

Stephen J. Cook

Sr. Director, GRC CSO and Tech Operations, GSK

Leads governance, risk and compliance for global digital and technology operations. Presented on the GSK AI initiative: building and scaling multi-agent AI systems in practice.

Subhabrata Purakayastha

Head of Enterprise GxP IT Systems Quality, Incyte

Presented on defining ownership and accountability for AI across GxP, and on risk-based assurance for AI-enabled systems.

Abhishek Bachchan

Associate Director, IT Security, Risk and Quality, Gilead

Presented on defining acceptance criteria for AI validation: making intelligent systems testable, defensible and inspection-ready.

Robert (Bob) Wherry

MSc, MS, VP, AI Compliance, QACV Consulting

Presented on the ten steps to achieving AI regulatory compliance: from AI inventory and risk classification through to the controls and documentation regulators expect to see.

Registration

INDIVIDUAL SEAT
$495

Live access to all four modules, the full takeaway toolkit, and the session recording afterward.

Register one seat

Larger group rates available. KENX does not issue refunds; registrations may be applied to a future KENX event or transferred to a colleague with at least seven days notice.

Common questions

Is this a certification?

No. This is a standalone training course, not a credential. There is no exam and nothing to maintain. You leave with material you can apply to your own program immediately.

Will the session be recorded?

Yes. Registered attendees receive access to the recording afterward, so a scheduling conflict on the day does not cost you the content.

Do I need a technical background?

No. The course is written for quality, validation, and regulatory professionals. The AI concepts are explained from the ground up, in the language of GxP.

How is this different from the AI in GxP conference?

The conference is peer exchange: case studies, practitioner panels, and the room. This is a taught curriculum with a defined syllabus and a toolkit you apply back at your own site.

Wednesday, October 28  ·  12:00 – 4:00 PM ET

Four hours that change how your team handles AI in a regulated environment.

Reserve your seat

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AI in GXP 2027 Outlook: Predictive Quality, Guardrails & Global Consistency

  • Webinar

AI in GXP 2027 Outlook: Predictive Quality, Guardrails & Global Consistency

What emerging technologies and regulatory thinking signal for the year ahead
Register Now
  • December 9, 11:00 AM - 12:15 PM EST

Sponsored by:

AI in GXP 2027 Outlook: Predictive Quality, Guardrails & Global Consistency

What emerging technologies and regulatory thinking signal for the year ahead

December 9, 11AM – 12:15 PM EST

AI expectations will continue to accelerate in 2027 as organizations adopt predictive analytics, strengthen governance, and align with global regulatory expectations. This webcast explores what’s coming next for AI use across GxP systems, including early regulatory indicators, emerging technologies, and best practices for maintaining oversight and consistency.

What You’ll Learn:

  • Early regulatory signals for 2027
  • Predictive quality and advanced analytics
  • Governance frameworks for responsible AI
  • Data integrity considerations for algorithmic systems
  • Documentation strategies supporting AI oversight
  • Emerging risks in AI deployment
  • Cross-functional collaboration models
  • Technology trends shaping next year’s capabilities

Who Should Attend:

Quality leaders, IT and digital transformation teams, regulatory professionals, validation and data integrity specialists, and anyone planning to expand AI use in 2027.

  • December 9
    11:00 AM - 12:15 PM EST
Register Now
If you’re interested in this webinar – check out following event(s)

Faculty

Building High-Quality Validation Documentation: Protocols, Reports, and Evidence That Stand Up to Scrutiny

  • Webinar

Building High-Quality Validation Documentation: Protocols, Reports, and Evidence That Stand Up to Scrutiny

Techniques for improving documentation clarity and consistency across traditional, digital, and AI-supported validation approaches
Register Now
  • January 20, 11AM - 12:15 PM EST

Building High-Quality Validation Documentation: Protocols, Reports, and Evidence That Stand Up to Scrutiny

Techniques for improving documentation clarity and consistency across traditional, digital, and AI-supported validation approaches

January 20, 11AM – 12:15 PM EST

Strong validation documentation remains essential for demonstrating system control, traceability, and compliance. This webcast focuses on practical methods for improving the quality of protocols, test scripts, and reports across diverse system types, from legacy to cloud to AI-supported environments. Learn how to simplify content, strengthen justification, and ensure documentation accurately reflects validation activities throughout the lifecycle.

What You’ll Learn:

  • Common documentation gaps and how to correct them
  • How to write clearer, more defensible protocols and test scripts
  • Best practices for integrating digital and cloud system evidence
  • How AI-supported tools influence documentation structure and content
  • Approaches for improving traceability and rationale within reports
  • Templates and formatting techniques that reduce confusion and redundancy
  • Strategies for aligning QA, system owners, and validation teams
  • Methods for maintaining consistency across multi-system environments

Who Should Attend:

Validation professionals, QA reviewers, documentation specialists, IT system owners, compliance leads, and anyone responsible for writing, reviewing, or approving validation deliverables.

  • January 20
    11AM - 12:15 PM EST
Register Now
If you’re interested in this webinar – check out following event(s)

Faculty