Special Tour of Lisbon

Spend the afternoon with us exploring Lisbon and its beautiful, historic surrounding area. Free for all ValGenesis customers and partners attending ValConnect. (Make sure to indicate your interest in the registration form below!)

Welcome Reception

Join us for a special reception. More information coming soon!

Welcome to ValConnect

Validation 4.0

In a thought-provoking presentation, we'll examine the future state of process validation. The changes from "check now and periodically re-check" to "continuous verification" will be covered, as well as the changes from static and finite documented evidence to live, dynamic digital records.

Portfolio Review and Product Roadmap

Join our VP of Product Management to see a comprehensive overview of the entire ValGenesis product portfolio with a special showcase of new products plus what's coming for VLMS, iRisk, Process Insight, and more.

Embracing Change: Otsuka's Journey Through CSA in the Era of Digital Transformation

In this session we will share a story of evolution, resilience, and progress regarding adoption of the CSA concept, digital transformation, and VLMS implementation. Understanding that this journey is not one of passive acceptance, we took a proactive approach to embracing change through active engagement and promotion of the new paradigm. This story will also highlight some successes and challenges experienced along the way.

iRisk as eQbD Knowledge Management System at CSL Behring

Explore the digitalization, centralization, and automatization of the QbD documentation suite in Plasma product development CMC at CSL, including challenges and successes over the eQbD journey.

AI and Beyond: What's New in VLMS 5.0

Be the first to see the brand-new, cutting-edge release of our flagship validation platform, including its industry-first AI capabilities and refined user experience.

CSA and CAPAs: Two Products of Risk Management

CDRH has promoted two of Case for Quality projects, Make CAPA Cool and Computer Software Assurance, as examples of focusing on business practices. The key point in both projects is the growing focus on risk, which is a pivotal component in decision making for all parties in life science product manufacturing. We will discuss FDA’s considerations and progress on these topics and discuss related questions and concerns.

Implementing iRisk for Effective Knowledge and Risk Management at Boehringer Ingelheim

See BI's step-by-step approach for the implementation of iRisk in Development Biologicals for the end-to-end process from CQA assessment over different types of Risk Assessments to Control Strategy Summary.

From Standards to ValGenesis – Becoming Fully Digital in Validation & Qualification

Follow the 15-year journey from paper-based validation and qualification to a fully digital solution and the sometimes stony path to a business-driven implementation supporting company standards.

GSK Vaccines Journey With iRisk

A timeline of GSK Vaccines' journey with iRisk, the main milestones along the way, benefits achieved, and next steps.

Revolutionizing Validation Strategies: Integrating CSA Draft Guidance Through VLMS Design Manager Module

Explores the optimization of validation strategies by integrating modern tools and adhering to CSA draft guidance. We will focus on leveraging the Design Manager module within VLMS to highlight how this product streamlines workflows, facilitates collaboration, and ensures compliance with evolving standards. In addition, it demonstrates the tangible benefits of this approach in accelerating validation timelines and improving risk management. Ultimately, it provides a roadmap for professionals looking to modernize their validation practices effectively.

Digital Transformation: Implementation of Global Paperless Validation and Qualification System

Experience the journey of Roche's impressive adoption of VLMS. We'll cover the pain points in paper-based validation, the power of standardization and harmonization, Roche's global implementation strategy, the current state of VLMS inside Roche.

Risk-Based Cleaning Validation

Gain insights into the proactive approach of risk-based cleaning validation, ensuring product safety and regulatory compliance. Explore how to optimize cleaning processes, mitigate risks, and enhance efficiency through strategic risk assessment methodologies. Discover key principles and best practices for implementing a robust risk-based cleaning validation framework.

iRisk at Corden Pharma: A Global Application for 10 Sites and a Case Study of QRM-driven Integration of PAT Tools in a Contained Plant

The presentation will share insight on Corden Pharma’s journey of deploying iRisk as a centralized QRM application over all sites and the benefits of this implementation for the development and lifecycle management of Corden Pharma's products. In addition, an examination of the obstacles and lessons learned, as well as the identified solutions. The presentation will feature a case study on the selection and implementation of PAT tools for a novel oral drug product manufactured in a contained plant.

How Generative AI May Impact the Validation of Computerized Systems

Dig into the frontier of generative AI and its potential within validation processes. Includes a discussion on agile validation, machine learning, the benefits of generative AI within automated testing, and primary validation use cases.

The Impact of AI and ML in Quality Risk Management

In this session, we will be addressing the regulatory advances and evolving expectations surrounding the integration of Artificial Intelligence (AI) and Machine Learning (ML) in Quality Risk Management (QRM). This presentation will provide a comprehensive overview of recent regulatory developments that shape the use of AI and ML, ensuring compliance and enhancing the robustness of QRM frameworks. We will also discuss the potential benefits these technologies bring, including improved accuracy in risk assessments, enhanced predictive capabilities, and optimized quality. Attendees will gain valuable knowledge on how to align with regulatory expectations while leveraging AI and ML to achieve superior risk management outcomes and drive innovation within their organizations.

AI-Driven, Real-Time Monitoring Toward Predictive Analysis and Enhanced Quality: A Practical approach

In an era where AI and ML are everywhere, pharma and biopharma industries should not be an exception. This talk explores the potential value of implementing real-time monitoring systems powered by machine learning and AI. These systems can predict the behavior of upcoming batches, mitigating risks and enhancing product quality.

Closing Comments and Open Forum With Executives

The ValGenesis executive team takes the stage in an open forum, taking questions from the audience about the product portfolio, the company, and beyond.

See you in 2025!