Harness the Power of AI in GxP – Singapore 2026

Harness the Power of AI in GxP - Singapore

Use Cases, Process Optimization, and Validation

Top 10 AI in GxP Challenges and Opportunities Life Science Leaders are Exploring IN 2026

Welcome to Harness the Power of AI in GxP Singapore

Use Cases, Process Optimization, and Validation

28-29 October, 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

★★★★★

I found the AI in GxP conference very beneficial conference to have attended. I came with the intent of looking at validating AI in vision but left also considering how we use it in generating system requirements and augmenting the validation process.

★★★★★

Really enjoyed the event, great speakers, meeting industry leaders and the event ran smoothly throughout the two days.

★★★★★

The Kenx conference was a must attend event for me in 2026 due to the prospective content, this was absolutely confirmed through the quality of the speakers, breadth of content and topics covered. It answered some key questions, and sparked a wealth of ideas as we move into this next paradigm

★★★★★

A highly informative and practical conference. ‘Harness the Power of AI in GxP’ delivered real insights and actionable strategies for applying AI in regulated spaces. Truly worth attending.

★★★★★

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.

★★★★★

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.

Harness the Power of AI in GxP – Toronto 2026

Harness the Power of AI in GxP - Toronto

Use Cases, Process Optimization, and Validation

Top 10 AI in GxP Challenges and Opportunities Life Science Leaders are Exploring IN 2026

Welcome to Harness the Power of AI in GxP

Use Cases, Process Optimization, and Validation

22-23 September, 2026 | Toronto

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

★★★★★

I found the AI in GxP conference very beneficial conference to have attended. I came with the intent of looking at validating AI in vision but left also considering how we use it in generating system requirements and augmenting the validation process.

★★★★★

Really enjoyed the event, great speakers, meeting industry leaders and the event ran smoothly throughout the two days.

★★★★★

The Kenx conference was a must attend event for me in 2026 due to the prospective content, this was absolutely confirmed through the quality of the speakers, breadth of content and topics covered. It answered some key questions, and sparked a wealth of ideas as we move into this next paradigm

★★★★★

A highly informative and practical conference. ‘Harness the Power of AI in GxP’ delivered real insights and actionable strategies for applying AI in regulated spaces. Truly worth attending.

★★★★★

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.

★★★★★

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.

Harness the Power of AI in GxP Europe 2026

Harness the Power of AI in GxP Europe

Use Cases, Process Optimization, and Validation

Top 10 AI in GxP Challenges and Opportunities Life Science Leaders are Exploring IN 2026

Welcome to Harness the Power of AI in GxP Europe

Use Cases, Process Optimization, and Validation, in beautiful Dublin, Ireland!

November 19-20, 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

★★★★★

I found the AI in GxP conference very beneficial conference to have attended. I came with the intent of looking at validating AI in vision but left also considering how we use it in generating system requirements and augmenting the validation process.

★★★★★

Really enjoyed the event, great speakers, meeting industry leaders and the event ran smoothly throughout the two days.

★★★★★

The Kenx conference was a must attend event for me in 2026 due to the prospective content, this was absolutely confirmed through the quality of the speakers, breadth of content and topics covered. It answered some key questions, and sparked a wealth of ideas as we move into this next paradigm

★★★★★

A highly informative and practical conference. ‘Harness the Power of AI in GxP’ delivered real insights and actionable strategies for applying AI in regulated spaces. Truly worth attending.

★★★★★

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.

★★★★★

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.

CSV & CSA University 2026

CSV & CSA University

Ensuring Compliance and Integrity Across Traditional, Digital, and AI-Driven Systems

Attend Virtually or In-Person

Top 10 Challenges CSV & CSA PROFESSIONALS are solving IN 2026

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!

★★★★★

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

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.

Harness the Power of AI in GxP – East 2026

Harness the Power of AI in GxP - East

Use Cases, Process Optimization, and Validation

Attend Virtually or In-Person

Top 10 AI in GxP Challenges and Opportunities Life Science Leaders are Exploring IN 2026

Gold Sponsors

Harness the Power of AI in GxP - East

Use Cases, Process Optimization, and Validation

15-16 September, 2026 | RTP, Durham

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

★★★★★

I found the AI in GxP conference very beneficial conference to have attended. I came with the intent of looking at validating AI in vision but left also considering how we use it in generating system requirements and augmenting the validation process.

★★★★★

Really enjoyed the event, great speakers, meeting industry leaders and the event ran smoothly throughout the two days.

★★★★★

The Kenx conference was a must attend event for me in 2026 due to the prospective content, this was absolutely confirmed through the quality of the speakers, breadth of content and topics covered. It answered some key questions, and sparked a wealth of ideas as we move into this next paradigm

★★★★★

A highly informative and practical conference. ‘Harness the Power of AI in GxP’ delivered real insights and actionable strategies for applying AI in regulated spaces. Truly worth attending.

★★★★★

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.

★★★★★

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.

Harness the Power of AI in GxP

Driving the 5.0 Evolution of Manufacturing, Validation, and Beyond

Attend Virtually or In-Person

Top 10 AI in GxP Challenges and Opportunities Life Science Leaders are Exploring IN 2026

Gold Sponsors

AI in GxP 2026

Driving the 5.0 Evolution of Manufacturing, Validation, and Beyond

May 12-13, 2026 | San Diego, CA

AI in GxP 2026 delivers practical, hands-on strategies for applying artificial intelligence across the core pillars of regulated life-science operations – validation, quality systems, manufacturing, engineering, facilities, automation, and IT. The program focuses on how real teams are using AI today to streamline processes, strengthen compliance, improve reliability, reduce manual effort, and accelerate decision-making across essential GxP activities. Designed for practitioners, this event emphasizes tangible examples, proven methods, and actionable tools that modernize day-to-day operations as organizations advance toward the 5.0 era.

Building on this foundation, the agenda extends into high-impact areas such as supply chain, labeling, batch records, clinical operations, tech transfer, and R&D – demonstrating how AI supports smarter decisions across the full product lifecycle. Sessions are designed to show how AI can be scaled responsibly and compliantly while increasing operational efficiency and cross-functional alignment.

What You’ll Learn

How AI enhances manufacturing performance, MES oversight, batch execution, and shop-floor visibility
How engineering and facilities teams use AI for predictive maintenance, reliability modeling, sensors, and process control
AI-driven approaches to environmental monitoring, contamination trending, and digital cleaning validation
How IT and automation groups validate and secure cloud, SaaS, cybersecurity, networks, and digital infrastructure
Risk-based methods for validating AI/ML models within CSV/CSA frameworks.
AI-enabled improvements to quality processes including documentation, training, deviations, CAPA, and continuous improvement
How AI supports supply chain planning, labeling accuracy, batch record automation, and tech transfer
Opportunities for AI in clinical operations, discovery, and R&D decision-making
Governance models for transparency, traceability, and responsible AI oversight
Regulatory expectations from FDA, EMA, MHRA, Annex 11/22, and emerging global guidance

Special Features

Case studies illustrating AI adoption across manufacturing, quality, engineering, facilities, supply chain, and IT
Walkthroughs of AI-enabled validation packages, documentation updates, and practical risk tools
Sessions on predictive maintenance, sensor analytics, and engineering reliability models
AI-driven environmental monitoring, contamination trending, and facility-control optimization
Digital cleaning validation, automated MACO calculations, and intelligent risk detection
Applied AI for MES insights, batch execution review, batch records, and automation systems
AI applications in labeling, supply chain integrity, tech transfer, clinical operations, and R&D
IT-focused sessions on cloud validation, cybersecurity, data integrity, and digital infrastructure assurance
Templates, checklists, and tools that teams can deploy immediately across GxP operations

Who Should Attend

Manufacturing, Facilities, and Operations Professionals
Engineering, Reliability, and Automation Teams
IT, Cybersecurity, Cloud, and Digital Infrastructure Leaders
Quality, Documentation, and Data Integrity Specialists
Validation, CSV/CSA, and Compliance Professionals
Supply Chain, Labeling, and Batch Record Teams
Clinical Operations, R&D, and Tech Transfer Staff
System Owners, Process Leads, and Project Managers
Anyone implementing, supporting, or validating AI-enabled GxP systems

★★★★★

I found the AI in GxP conference very beneficial conference to have attended. I came with the intent of looking at validating AI in vision but left also considering how we use it in generating system requirements and augmenting the validation process.

★★★★★

Really enjoyed the event, great speakers, meeting industry leaders and the event ran smoothly throughout the two days.

★★★★★

The Kenx conference was a must attend event for me in 2026 due to the prospective content, this was absolutely confirmed through the quality of the speakers, breadth of content and topics covered. It answered some key questions, and sparked a wealth of ideas as we move into this next paradigm

★★★★★

A highly informative and practical conference. ‘Harness the Power of AI in GxP’ delivered real insights and actionable strategies for applying AI in regulated spaces. Truly worth attending.

★★★★★

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.

★★★★★

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.

Sterility Assurance University 2026

Sterility Assurance University

Advancing Microbiology, CCS, Cleaning Validation, EM, Digital Tools & Risk-Based Strategies Across the Lifecycle

Attend Virtually or In-Person

Top 10 Challenges STERILITY ASSURANCE LEADERS are solving IN 2026

Gold Sponsors

Overview

Sterility Assurance University is the industry’s most focused event dedicated to microbiology, contamination control strategy (CCS), and sterility assurance across the product lifecycle. This two-day summit brings together leading experts from pharma, biopharma, and device organizations to share actionable insights on Annex 1 implementation, environmental monitoring, aseptic processing, and cleaning validation — including lifecycle development, data-driven approaches, and regulatory alignment. Whether you’re preparing for inspections or proactively strengthening your programs, this is your go-to event for expert guidance, peer networking, and practical tools.

Top 10 Reasons to Attend

Implement a site-wide CCS aligned with Annex 1 and current regulatory expectations
Explore environmental monitoring design, trending, and excursion investigations
Strengthen your cleaning validation lifecycle from acceptance limits to tech transfer
Discover strategies for managing microbial excursions and aseptic process failures
Learn from real-world case studies on gowning, airflow, smoke studies, and visual inspection
Understand rapid methods, automation, and AI for proactive microbial control
Benchmark personnel monitoring and objectionable organism risk assessments
Identify design and facility risks that impact contamination control
Take home SOPs, checklists, and other takeaway tools you can apply immediately
Hear directly from Sanofi, Takeda, Alcon, Charles River Laboratories, and Bausch + Lomb as they share how they’re advancing sterility assurance and contamination control

Who Should Attend

Microbiology & Environmental Monitoring Professionals
Quality Assurance & Quality Control Leaders
Validation, Sterility Assurance & Aseptic Processing Personnel
Regulatory Affairs & Inspection Readiness Teams
Facilities, Engineering & Cleanroom Design Specialists
Manufacturing, Operations, and Technical Services
R&D and Process Development Teams
Consultants and Service Providers in the Sterility Space

★★★★★

This was one of the most effective conferences I ever attended: very well organized with choices and knowledgeable presenters.

★★★★★

Great convention. I enjoyed the presentations and seeing the passion there is for doing the right thing in the industry. Very refreshing.

★★★★★

I thoroughly enjoyed attending the conference. The relaxed and low-key atmosphere fostered a strong sense of engagement among the audience and created a comfortable space for openly sharing insights. I particularly appreciated the attendees’ openness to learning and their willingness to kindly share their experiences and expertise. I also greatly valued the productive discussions both at the end of the presentations and during the networking breaks. It truly felt like a collaborative and enriching environment. Thank you for organizing such a great event!

★★★★★

Attending the Sterility Assurance University conference was a game-changer. The sessions were packed with cutting-edge insights, practical strategies, and real-world case studies that elevated our understanding of contamination control and regulatory compliance. The speakers were industry leaders who brought clarity to complex topics, and the networking opportunities were invaluable. We left feeling empowered, informed, and ready to implement best practices with confidence.

★★★★★

All speakers were informative, with good detailed presentations. Everyone was professional, and very easy to speak with, the conference was on point.

MedTech Innovation & Validation University 2026

MedTech Innovation & Validation University

Integrating Compliance, Design, and Post Market Success

Attend Virtually or In-Person

Top 10 Challenges MEDTECH VALIDATION & INNOVATION LEADERS are solving IN 2026

Gold Sponsors

Overview

The regulatory landscape has shifted – and MedTech Validation & Innovation University 2026 is your opportunity to build a forward-looking validation program that’s compliant, flexible, and audit-ready. From FDA’s QMSR overhaul to AI/ML final guidance, cybersecurity enforcement, and LDT oversight rollout, regulatory expectations are no longer evolving — they’re here. This program delivers real-world strategies, case studies, and hands-on tools to help you implement what matters most – now.

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

34 sessions across CSA, QMSR, AI, Postmarket, and Global Regulatory
Action-driven titles and case studies — no theory-heavy fluff
New LDT session focused on complaint handling and labeling requirements
Cybersecurity tracks and panels tied to real audit trends and SBOM guidance
Hands-on workshops for CSA validation and EU MDR/IVDR strategy
Sessions addressing global authorities: Health Canada, TGA, ANVISA, and EU NB expectations
Expert-led panels and Q&A sessions featuring industry and regulatory specialists

★★★★★

Great event that brings Industry and regulators together!

★★★★★

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

★★★★★

Presentations for the most part were excellent. Very well organized. Excellent Agenda and Compendium

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.

Harness the Power of AI in GxP Puerto Rico 2026

Harness the Power of AI in GxP Puerto Rico

Use Cases, Process Optimization, and Validation

Top 10 AI in GxP Challenges and Opportunities Life Science Leaders are Exploring IN 2026

Gold Sponsors

Welcome to Harness the Power of AI in GxP – Puerto Rico

Use Cases, Process Optimization, and Validation, in beautiful Puerto Rico

November 3-4, 2026 | San Juan, PR

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

★★★★★

I found the AI in GxP conference very beneficial conference to have attended. I came with the intent of looking at validating AI in vision but left also considering how we use it in generating system requirements and augmenting the validation process.

★★★★★

Really enjoyed the event, great speakers, meeting industry leaders and the event ran smoothly throughout the two days.

★★★★★

The Kenx conference was a must attend event for me in 2026 due to the prospective content, this was absolutely confirmed through the quality of the speakers, breadth of content and topics covered. It answered some key questions, and sparked a wealth of ideas as we move into this next paradigm

★★★★★

A highly informative and practical conference. ‘Harness the Power of AI in GxP’ delivered real insights and actionable strategies for applying AI in regulated spaces. Truly worth attending.

★★★★★

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.

★★★★★

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.

GMP University 2026

GMP University

Modernizing GMP Processes from Risk to Inspections

Attend Virtually or In-Person

Top 10 Challenges GMP LEADERS are solving IN 2026

Gold Sponsors

Overview

GMP University 2026 takes a deeper dive into advanced GMP topics and the latest industry trends. This two-day conference in La Jolla, CA 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!

★★★★★

Great event that brings Industry and regulators together!

★★★★★

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

★★★★★

Presentations for the most part were excellent. Very well organized. Excellent Agenda and Compendium

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.

Harness the Power of AI in GxP - Singapore

Use Cases, Process Optimization, and Validation

Top 10 AI in GxP Challenges and Opportunities Life Science Leaders are Exploring IN 2026

Welcome to Harness the Power of AI in GxP Singapore

Session Highlights: Dive into Real-World Use Cases and Compliance Strategies

Understanding Regulatory Frameworks for AI in GxP

Case Studies and Validation of AI in GxP

Who Should Attend

VENUE

Harness the Power of AI in GxP - Toronto

Use Cases, Process Optimization, and Validation

Top 10 AI in GxP Challenges and Opportunities Life Science Leaders are Exploring IN 2026

Welcome to Harness the Power of AI in GxP

Session Highlights: Dive into Real-World Use Cases and Compliance Strategies

Understanding Regulatory Frameworks for AI in GxP

Case Studies and Validation of AI in GxP

Who Should Attend

VENUE

Harness the Power of AI in GxP Europe

Use Cases, Process Optimization, and Validation

Top 10 AI in GxP Challenges and Opportunities Life Science Leaders are Exploring IN 2026

Welcome to Harness the Power of AI in GxP Europe

Session Highlights: Dive into Real-World Use Cases and Compliance Strategies

Understanding Regulatory Frameworks for AI in GxP

Case Studies and Validation of AI in GxP

Who Should Attend

VENUE

CSV & CSA University

Ensuring Compliance and Integrity Across Traditional, Digital, and AI-Driven Systems

Top 10 Challenges CSV & CSA PROFESSIONALS are solving IN 2026

Gold Sponsors

Key Learning Opportunities:

Event Features:

VENUE

Harness the Power of AI in GxP - East

Use Cases, Process Optimization, and Validation

Top 10 AI in GxP Challenges and Opportunities Life Science Leaders are Exploring IN 2026

Gold Sponsors

Harness the Power of AI in GxP - East