Doors Open

Welcome Session

Our CMO, David Medina, will welcome the attendees and go over the agenda and everything about the event.

AI is the new baseline in Life Sciences

The organizations pulling ahead aren't asking whether to adopt it, but how to scale it with compliance and quality woven into the foundation. In this session, we will hear on what are the latest trends, gotcha moments, success stories, where is AI being adopted where is it a laggard and what has a successful AI journey looked like.

AI in Action: How VAL™ is Redefining Validation and Compliance    

Explore the next generation of validation powered by VAL™ AI. Through real pilot experiences and customer outcomes, discover how AI is enhancing productivity, improving compliance, and enabling smarter decision-making across regulated environments.

The ValGenesis Smart GxP Platform Vision & Roadmap    

Explore the vision and roadmap for the ValGenesis Smart GxP™ platform, the industry’s first AI-native platform designed to unify validation and process lifecycle management across the product lifecycle. This session will highlight how the Validation Lifecycle Suite (VLS) and Process Lifecycle Suite (PLS) work together to connect process development, CQV, CPV, and commercial manufacturing, enabling seamless digitalization, intelligent automation, and accelerated tech transfer from lab to launch.

Biocon’s Digital Qualification and Validation Journey

Sachin Shinde from Biocon shares how the company scaled ValGenesis across their sites in India and Malaysia and leveraged the platform in support of their equipment qualification and computer software validation activities.

Digital Validation at Dr. Reddy’s Laboratories

DRL has leveraged ValGenesis to digitalize the validation of (computer systems, equipment, facilities, instruments), and infrastructure qualification activities across multiple Sites in India and abroad. Rajesh will discuss the impact of DRL's ValGenesis implementation and how it aligns with the organization's digital transformation roadmap. 

Cleaning Validation

A presentation and a practical demonstration of how iClean not only automates, but digitalizes cleaning operations, optimizing the efficiency of operations while ensuring that cleaning validation is always up to date.

Panel Discussion: From Process Design to Continuous Verification: The Future of AI-Driven Validation    

As process validation evolves, AI and digitalization are creating new opportunities to improve efficiency, decision-making, and product quality. Join industry experts as they explore how emerging technologies are transforming each stage of the validation lifecycle and what it takes to successfully implement them in regulated environments.

Moderator: David Medina, CMO, ValGenesis 
Siva Samy, PhD., CEO & Chief Product Strategist, ValGenesis
Cody Maher, Vice President, Product Management, ValGenesis
Prem Iyangar, Managing Director, Practice Lead – Life Science Industry Technology – India
Rajesh Thempadiyil, Head -Digital & Process Excellence for (Manufacturing & Quality), Dr. Reddy's Laboratories (DRL)

Accelerating Validation Through Digital Transformation at FDC Limited

Priya Singh will share how at FDC they successfully digitized method development, equipment qualification, and computer system validation as part of its broader digital transformation roadmap with ValGenesis. The session will highlight measurable gains in cycle time, resource efficiency, audit readiness, and compliance, along with the implementation challenges encountered and how the team overcame them.

Supporting Digital Transformation Across the Life Sciences Enterprise    

Learn how ValGenesis' Digital Transformation team helps organizations maximize the value of their ValGenesis solutions while building a clear path for long-term digital transformation. The session will highlight how a strategic approach to that transformation can drive optimization, accelerate adoption, and support scalable business outcomes.

Closing Remarks