AI in GxP: Governance, Validation, and Inspection Readiness (Recording)
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Inspection Ready: Fixing the GMP Gaps That Lead to 483s
Seats are limited. Registration closes as soon as capacity is reached.
KENX VIRTUAL TRAINING · HALF DAY · LIVE ONLINE
Inspection Ready: Fixing the GMP Gaps That Lead to 483s
Three and a half hours with industry quality leaders on the investigation, computerized system, and change control gaps that keep turning into inspection findings, and how to close them before an investigator finds them.
Tuesday, December 2, 2026. 12:00 to 3:30 PM EST. $325 early bird through November 20 · $395 after
Bringing your team? Up to 8 seats for $1,495. Larger groups, contact info@kenx.org.
Your faculty
Quality, IT and regulatory leaders from regulated manufacturers, teaching the material they presented on stage. No vendor pitches.
Cindy Duhigg
Senior Principal, Global Manufacturing Science & Technology Engineering, Alcon
Raul Soto
MedTech Senior Manager, Johnson & Johnson
Tim Roy Kirkelie
Co-Founder & COO, Genari AI
Why this training, and why now
The same gaps keep showing up on 483s year after year. Investigations close without a real root cause. Validated systems fall apart when an inspector pulls the audit trail. Changes go through without an impact assessment that would survive review. None of these are new problems, and that is exactly why investigators keep finding them.
INVESTIGATIONS
21 CFR 211.192 is consistently among the most cited drug GMP observations. “Root cause not identified” is rarely accepted as a conclusion.
COMPUTERIZED SYSTEMS
Audit trails, access controls, and data integrity remain a primary focus when inspectors review validated systems.
CHANGE CONTROL
Weak impact assessments and changes made without adequate review are recurring themes in 483s, especially when they touch validated processes or systems.
The three modules
MODULE ONE
12:05 to 12:55 PM EST
Investigations That Hold Up
Cindy Duhigg, Senior Principal, Global Manufacturing Science & Technology Engineering, Alcon
Why “root cause not identified” keeps appearing in 483s, how to scope an investigation so it reaches a defensible root cause, and how to link that root cause to a CAPA that actually holds.
MODULE TWO
1:05 to 1:55 PM EST
Surviving an Audit of Your Validated Computerized Systems
Raul Soto, MedTech Senior Manager, Johnson & Johnson
What inspectors look at first in a validated system, the audit trail, access control, and data integrity expectations behind it, and how to keep your validation evidence inspection ready between audits.
MODULE THREE
2:05 to 2:55 PM EST
Inspection-Proof Change Control
Tim Roy Kirkelie, Co-Founder & COO, Genari AI
Why well-intended changes still end up on 483s, the change control failure modes inspectors find most often, what “risk-based” really means to a reviewer, and how to build impact assessments that hold up.
LIVE Q&A
2:55 to 3:30 PM EST
Open Q&A
Bring the finding your site is worried about. Submit questions in advance at registration and we will work through as many as time allows.
What you leave with
01Investigation report checklist for closing with a defensible root cause
02Root cause to CAPA linkage worksheet
03Computerized system audit readiness checklist
04Change control impact assessment template
05Inspection question set covering all three areas
06Full recording of the session
Who should be in the room
QA and compliance leaders
Investigation, deviation, and CAPA owners
Validation, CSV, and CSA professionals
Manufacturing and laboratory quality teams
Data integrity and GxP IT roles
Sites preparing for a pre-approval or surveillance inspection
Registration
INDIVIDUAL
$325 early bird
Through December 2. $395 after.
One seat. Includes live access, the full toolkit, and the session recording.
TEAM
$1,495
Up to 8 seats for your team, each with live access, the toolkit, and the recording. Larger group rates are available.
No refunds are issued. With at least seven days’ notice, your registration can be transferred to a colleague or applied to a future KENX event.
Common questions
Is this a certification?
No. This is standalone training. There is no exam or credential.
Will the session be recorded?
Yes. Every registered attendee receives the recording, so you can revisit it or catch anything you missed.
How is this different from GMP University?
GMP University is a two-day conference built around peer exchange. This is a focused, taught half day with a practical toolkit, designed so your whole team can attend without travel.
Can I register my whole team?
Yes. The team rate covers up to 8 seats for $1,495. For larger groups, email info@kenx.org.
Close the gaps before an investigator finds them.
Tuesday, December 2, 2026 · 12:00 to 3:30 PM EST · Live online
Validating Cloud and Hybrid GxP Systems
Recorded live
Validating Cloud and Hybrid GxP Systems
Supplier Assessment, Change Control, and Vendor-Deployed AI
Nithin Sashidharan
Senior Medical Director Allucent
Paul Labas
Director, Computerized Systems Compliance Sarah Cannon Research Institute
Stephen J. Cook
Sr. Director, Governance & Operational Excellence, Global Digital & Tech GSK
Ahmed Tahoun
Digital Compliance Specialist Cencora
Watch the full session
The full recording opens immediately. No membership, no charge.
Access granted
Validating Cloud and Hybrid GxP Systems
Most GxP environments are now hybrid whether anyone planned it or not. Legacy on-premise systems sit alongside SaaS platforms that update on the vendor’s schedule, not yours, and the validation package written at implementation assumed a system that would hold still. It hasn’t. Meanwhile suppliers are shipping AI features into validated systems as routine releases, and most quality organizations have no mechanism to catch it, assess it, or document a decision about it. This session covers how to validate systems you do not control: what to demand from supplier assessment and how far you can lean on vendor testing under CSA, how to build change control that survives a quarterly release cadence, and what to do when a feature you did not ask for lands inside a validated application.
What You'll Gain:
- Understand where supplier qualification ends and your validation obligation begins in a shared responsibility model
- Learn how to leverage supplier testing evidence under a risk-based CSA approach, and where regulators expect you to test anyway
- See how to design change control and periodic review around vendor release cycles rather than against them
- Discover how to assess and document vendor-deployed AI features introduced into validated systems
- Gain insight into what GAMP 5 Second Edition asks for in cloud and hybrid environments, applied rather than summarized
- Hear how organizations are handling this in practice, including what has failed
Who Should Attend:
- CSV, CSA, and computerized systems validation professionals
- Quality assurance and IT compliance leads
- System owners and business process owners for cloud-based GxP applications
- Supplier qualification and vendor management professionals
AI in GxP, Singapore
- Conference
AI in GxP, Singapore
Use Cases, Process Optimization, and Validation
- Singapore
- November 19-20
- Early Bird Sales end on Oct 16, 2026
Top 10 AI in GxP Challenges and Opportunities Life Science Leaders are Exploring IN 2026
Gold Sponsors
AI in GxP Singapore
Use Cases, Process Optimization, and Validation
November 19-20, 2026 | Singapore
Join us for an immersive 2-day event focused on leveraging and validating Artificial Intelligence (AI) to drive innovation and efficiency within the GxP environment. “Harness the Power of AI in GxP” will feature a series of case study driven sessions that reveal the latest developments in AI applications, process optimization, validation, and compliance within regulated life sciences industries. Whether your goal is to validate AI for regulatory compliance, streamline manufacturing, or ensure data integrity, this conference delivers actionable insights to keep you at the forefront of technology and regulation.
Session Highlights: Dive into Real-World Use Cases and Compliance Strategies
Understanding Regulatory Frameworks for AI in GxP
Explore essential regulatory considerations, including FDA guidance on AI, Part 11 compliance for electronic records, and the latest on data integrity standards. Industry experts will provide insights into ISPE® AI quality and compliance initiative and discuss how to ensure alignment with global standards.
- Navigating FDA guidance on AI/ML in life sciences
- Part 11 compliance: Ensuring secure and accurate electronic records
- ISPE® AI Quality and Compliance Initiative: An in-depth overview
- Addressing data integrity challenges in AI-driven processes
- Managing regulatory expectations across global markets
- Ensuring transparency and accountability in AI validation processes
Case Studies and Validation of AI in GxP
Learn from specific use cases demonstrating how AI is transforming GxP processes. Topics include optimizing manufacturing workflows, enhancing validation accuracy, and applying predictive analytics in quality control. Sessions will also cover best practices for validating AI processes to meet compliance requirements, ensuring safe and effective AI implementation in regulated environments.
- AI-driven automation in GMP environments: Practical examples
- Optimizing quality control and data integrity through AI
- Best practices for validating AI algorithms and models
- Leveraging predictive analytics for preventive maintenance
- Case study: AI applications in continuous process improvement
- Enhancing validation speed and accuracy with AI
- Real-world applications of AI in manufacturing and supply chain
Who Should Attend
This conference is ideal for professionals in the life sciences industry involved in validation, quality assurance, compliance, and AI integration within GxP settings. If you’re responsible for maintaining regulatory standards while implementing cutting-edge AI technologies, this event is tailored for you. Attendees in the following roles will especially benefit:
- Validation Engineers
- Quality Assurance Professionals
- Process Engineers
- Regulatory Affairs Specialists
- AI and Data Science Experts in Life Sciences
- Compliance Officers
- IT and Digital Transformation Leaders in GxP
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.
AI in GxP, Europe – 2026
- Conference
AI in GxP, Europe
Use Cases, Process Optimization, and Validation
- Amsterdam, NE
- October 14-15
- Early Bird Pricing starting at €1,795 through 11 September
Top 10 AI in GxP Challenges and Opportunities Life Science Leaders are Exploring IN 2026
Platinum
Sponsors
Gold Sponsors
AI in GxP Europe
Use Cases, Process Optimization, and Validation, in beautiful Amsterdam!
October 14-15, 2026 | Amsterdam
Join us for an immersive 2-day event focused on leveraging and validating Artificial Intelligence (AI) to drive innovation and efficiency within the GxP environment. “Harness the Power of AI in GxP” will feature a series of case study driven sessions that reveal the latest developments in AI applications, process optimization, validation, and compliance within regulated life sciences industries. Whether your goal is to validate AI for regulatory compliance, streamline manufacturing, or ensure data integrity, this conference delivers actionable insights to keep you at the forefront of technology and regulation.
Session Highlights: Dive into Real-World Use Cases and Compliance Strategies
Understanding Regulatory Frameworks for AI in GxP
Explore essential regulatory considerations, including FDA guidance on AI, Part 11 compliance for electronic records, and the latest on data integrity standards. Industry experts will provide insights into ISPE® AI quality and compliance initiative and discuss how to ensure alignment with global standards.
- Navigating FDA guidance on AI/ML in life sciences
- Part 11 compliance: Ensuring secure and accurate electronic records
- ISPE® AI Quality and Compliance Initiative: An in-depth overview
- Addressing data integrity challenges in AI-driven processes
- Managing regulatory expectations across global markets
- Ensuring transparency and accountability in AI validation processes
Case Studies and Validation of AI in GxP
Learn from specific use cases demonstrating how AI is transforming GxP processes. Topics include optimizing manufacturing workflows, enhancing validation accuracy, and applying predictive analytics in quality control. Sessions will also cover best practices for validating AI processes to meet compliance requirements, ensuring safe and effective AI implementation in regulated environments.
- AI-driven automation in GMP environments: Practical examples
- Optimizing quality control and data integrity through AI
- Best practices for validating AI algorithms and models
- Leveraging predictive analytics for preventive maintenance
- Case study: AI applications in continuous process improvement
- Enhancing validation speed and accuracy with AI
- Real-world applications of AI in manufacturing and supply chain
Who Should Attend
This conference is ideal for professionals in the life sciences industry involved in validation, quality assurance, compliance, and AI integration within GxP settings. If you’re responsible for maintaining regulatory standards while implementing cutting-edge AI technologies, this event is tailored for you. Attendees in the following roles will especially benefit:
- Validation Engineers
- Quality Assurance Professionals
- Process Engineers
- Regulatory Affairs Specialists
- AI and Data Science Experts in Life Sciences
- Compliance Officers
- IT and Digital Transformation Leaders in GxP
VENUE
The Four Elements Hotel Amsterdam
Bert Haanstrakade 1074
1087 HJ
Amsterdam
The Netherlands
Bert Haanstrakade 1074
1087 HJ
Amsterdam
The Netherlands
To reserve your room, please email reservations@fourelementshotel.com and be sure to include the stay is for the KENX conference.
Faculty
Abhishek Bachchan
Sachin Bhandari
Kirsten Ceusters
Audrey Cummins
Dr. Steven Davy
Mark Devaney
Parsa Famili
Martin Kisselbach
Michael Martone
Laura Mihaylova
Giovana Mobiglia
Stefan Münch
Donnacha Nagle
Andy O’Connor
Dr. Kevin O’Donnell
Ben O’Brien
Duraisamy Rajan Palani
Frederik Thiele
Ilangathir Venugopal
David W. Vincent
Michael Wegmann
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
- Conference
CSV & CSA University
Ensuring Compliance and Integrity Across Traditional, Digital, and AI-Driven Systems
- San Diego, CA
- December 9-10
- Early Bird Pricing starting at $1,795 through November 6th
Attend Virtually or In-Person
Top 10 Challenges CSV & CSA PROFESSIONALS are solving IN 2026
Platinum
Sponsors
Gold Sponsors
Dive into the world of Computer System Validation (CSV) and Computer Software Assurance (CSA) at CSV & CSA University 2026! This two-day event is tailored for professionals focused on quality assurance, compliance, and the integration of technology within regulated industries. Gain a comprehensive understanding of the latest methodologies and regulatory expectations that govern software validation and assurance practices.
Key Learning Opportunities:
CSV & CSA University offers a rich curriculum designed to equip you with the essential knowledge and skills needed in today’s digital landscape. Focus areas include:
-
Foundations of Computer System Validation:
Discover the core principles of CSV, including best practices for documentation, validation planning, and execution. -
Transitioning to Computer Software Assurance:
Learn about the CSA approach, which emphasizes a risk-based strategy for validating software systems, streamlining processes while maintaining compliance. -
Implementation of Quality Management Systems:
Understand how to integrate quality management principles into your CSV and CSA strategies to enhance overall operational efficiency. -
Regulatory Insights and Case Studies:
Explore real-world examples and lessons learned from organizations navigating the evolving regulatory landscape. -
Data Integrity & Security:
Address the challenges of ensuring data integrity and cybersecurity in increasingly complex digital environments.
Event Features:
-
Dynamic Workshops & Training Sessions:
Engage in hands-on workshops that allow you to apply key concepts and tools directly to your work in CSV and CSA. -
Expert Keynote Speakers:
Gain insights from thought leaders and regulatory experts who will share their experiences and predictions for the future of software validation. -
Panel Discussions & Networking Events:
Participate in lively discussions on contemporary issues in the field and take advantage of ample networking opportunities with industry peers. -
Collaborative Problem-Solving:
Join facilitated sessions designed to tackle real-world challenges in CSV and CSA, fostering a collaborative learning environment.
CSV & CSA University 2026 is your gateway to mastering the critical components of software validation and assurance in a rapidly changing regulatory environment. Join us in San Diego, CA fromDecember 9-10, 2026, and position yourself at the forefront of industry best practices and innovative solutions. Secure your spot today!
Faculty
Geetanjali Abbi
Anant Agrawal
Arvind Chauhan
Stephen J Cook
David DeLuca
Zach Dickinson
Maureen Doyle-Spare
Ivan Feliciano
Varun Gadde
Madhavi Ganesan
William Gargano
Joanne Goldberg
Dori Gonzalez-Acevedo
Connie Hetzler
Tim Roy Kirkelie
Jade Kondo
Paul Labas
Emily Lomax
Duraisamy Rajan Palani
Yari Fontebasso, PhD
Binesh Prabhakar
Bharani Rajendran
Gunjot Rana
Jeanette Heacock, RPh
Raul Soto
Staci Spencer
Vignesh Srinivas
Radia Wahab
Gaurav Walia
Robert J. Wherry
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.
GMP University
- Conference
GMP University
Modernizing GMP Processes from Risk to Inspections
- Philadelphia, PA
- October 7-8
- Prices increase September 11!
Attend Virtually or In-Person
Top 10 Challenges GMP LEADERS are solving IN 2026
Platinum
Sponsors
Gold Sponsors
Overview
GMP University 2026 takes a deeper dive into advanced GMP topics and the latest industry trends. This two-day conference in Philadelphia, PA is designed for professionals who want to stay at the forefront of Good Manufacturing Practices, explore new technologies, and learn how to implement best practices for regulatory compliance and operational excellence.
What You’ll Gain
GMP University 2026 focuses on emerging challenges and innovations in the GMP landscape, offering insights into the future of compliance and quality assurance. Key topics include:
- Modernizing Quality Systems: Learn about the latest approaches to building resilient and agile quality systems that adapt to regulatory changes.
- Digital Transformation in GMP: Discover how automation, data analytics, and digital tools are reshaping GMP processes, from documentation to quality control.
- Risk Management & Continuous Improvement: Explore advanced risk management strategies that support continuous improvement and help maintain compliance.
- Supplier & Supply Chain Management: Gain insights into GMP compliance across global supply chains, including supplier qualification and risk mitigation.
- Regulatory Updates & Compliance: Stay informed about current and upcoming regulatory changes and understand what they mean for your operations.
Event Highlights:
- Expert-Led Sessions & Case Studies: Participate in in-depth presentations and case studies from industry leaders who are innovating in GMP.
- Workshops & Hands-On Learning: Take part in interactive workshops that focus on applying new GMP trends and best practices in real-world scenarios.
- Risk Management & Continuous Improvement: Explore advanced risk management strategies that support continuous improvement and help maintain compliance.
- Networking with Industry Leaders: Connect with peers, vendors, and key opinion leaders to share insights, explore challenges, and build partnerships.
GMP University 2026 is your opportunity to enhance your understanding of modern GMP practices, keep up with regulatory demands, and prepare your organization for the future. Don’t miss this chance to immerse yourself in two days of advanced learning and professional growth—register today for GMP University in Philadelphia, October 7-8, 2026!
Faculty
Federico Barbarossa
Rosalind Beasley
Chip Bennett
Michelle Bonn
Douglas Brown
David DeLuca
Cindy Duhigg
Benjamin Duncan
Rebecca Fuller
Dori Gonzalez-Acevedo
Michael Higgins
Margaret Hindley
Jim Polarine Jr.
Krishna Kotha
George Kwiecinski
Leslie Lighton-Humphreys
Gourav Pandey
Xenophon Papademetris
Dishant Sanghavi
Shawn M. Schmitt
Steve Silverman
Abhinavdutt Singh
Raul Soto
Tarun Srivastava
David W. Vincent
Gaurav Walia
Amy Wilhite
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.
