From June 17 through June 19, Lisbon, Portugal, played host to ValConnect 2024, the annual ValGenesis user conference. This international event brought together a diverse mix of customers, industry experts, ValGenesis employees, and partners, including Ambit, winner of the Partner of the Year prize. More than 100 attendees from across Europe, Japan, and the U.S. united to explore the future of regulatory compliance and validation.
Presentation Highlights
ValConnect 2024 featured insightful presentations showcasing the latest advancements and strategies impacting the life sciences industry. From cutting-edge technologies like Artificial Intelligence (AI) and Machine Learning (ML) in quality risk management to transformative approaches in validation strategies, each session offered exciting glimpses into the future of regulatory compliance and innovation. Session highlights include:
CSA and CAPAs
Daniel Walter, Policy Analyst, Compliance and Quality Staff, FDA, provided an in-depth look at the FDA's approach to computer software assurance (CSA) and corrective and preventive actions (CAPAs). His session emphasized the importance of modernizing compliance practices to incorporate CSA principles, focusing on critical thinking and risk-based decision-making to enhance overall process efficiency and product quality.
Revolutionizing Validation Strategies
Emmanuel Cansino, Senior Director of Industry Solutions at ValGenesis, presented innovative strategies for revolutionizing validation in the pharmaceutical industry. He discussed how advanced technologies like AI and ML can improve traditional validation methods, highlighting successful implementations and the potential for continuous innovation and adaptation.
Validation 4.0
Ângela Martinho, VP of Consulting Services at ValGenesis, shared a historical perspective on the evolution of industry practices leading to Validation 4.0. Her session focused on integrating holistic validation approaches to support Pharma 4.0, emphasizing Quality by Design (QbD), process mapping, and risk management to achieve continuous verification and improvement.
Risk-Based Cleaning Validation
Rui Almeida, Director of Consulting Services at ValGenesis, introduced a risk-based approach to cleaning validation. He compared traditional methods with the FDA's lifecycle model, highlighting the importance of a scientific and data-driven approach to ensuring compliance, product quality, and equipment effectiveness while addressing regulatory challenges.
AI-Driven, Real-Time Monitoring Toward Predictive Analysis and Enhanced Quality: A Practical Approach
Sandra Silva, Director of Product Management — CPV at ValGenesis, explored AI-driven, real-time monitoring solutions for continued process verification (CPV). Her session showcased how real-time data acquisition and analysis enable proactive quality management and rapid response to deviations, enhancing process control and compliance through AI integration.
The Impact of AI and ML in Quality Risk Management
Ricardo Leandro, Group Product Manager — Risk at ValGenesis, discussed the integration of AI and ML in quality risk management. He explained how they can enhance decision-making and process optimization by identifying patterns, predicting risks, and recommending mitigation strategies, thus improving compliance and reducing operational risks.
Other noteworthy presentations covered a range of critical topics. Alexandre Zegels from CSL Behring discussed iRisk as an eQbD knowledge management system; Susanne Weiler from Boehringer Ingelheim shared BI’s experience implementing iRisk; and Bianca Valentim from GSK highlighted GSK Vaccines' journey with iRisk. Mani Palaniappan from Roche Singapore presented on digital transformation at Roche, while Sathish Kumar Shanmugam from ValGenesis delved into generative AI in validation. Kevin Shaw, VP of Product Management, presented the product roadmap, and Sophia Vraka explored what's new in VLMS 5.0.
We want to thank all of our knowledgeable presenters. Many of their insights will be shared in upcoming blog posts and other educational resources.
Customer Success Stories
Customer success stories were a significant highlight at ValConnect 2024, showcasing how ValGenesis products are transforming validation and risk management processes across the industry.
Dr. Imtiaz H. Mohiuddin, Senior Director of Global Quality Solutions at Otsuka, outlined Otsuka’s journey through CSA. He detailed their transition from a paper-based system to digital validation using VLMS, emphasizing the substantial reduction in validation cycle time and documentation. Dr. Mohiuddin shared insights into the global rollout challenges and the critical role of digital tools in enhancing Otsuka's validation framework.
Sigrun Seeger and Verena Buhl from Bayer shared their company’s digital transformation journey. They focused on integrating ValGenesis to achieve full digitalization of their validation processes, highlighting significant improvements in operational efficiency, data accuracy, and regulatory compliance. The session underscored the importance of change management and stakeholder buy-in for successful digital transformation.
Dr. Iris Ziegler, Director of QbD & Pharmaceutical Sciences at Corden Pharma, presented Corden Pharma's case study on implementing iRisk for quality by design (QbD) and lifecycle management. She emphasized the importance of systematic QbD approaches in ensuring product quality and safety, highlighting the benefits of iRisk in managing knowledge and facilitating continuous improvement. Dr. Ziegler shared the challenges of integrating risk management across multiple sites and the value of a unified, digital risk management tool in achieving robust and compliant manufacturing processes.
Unveiling VLMS 5.0
A major highlight of ValConnect 2024 was the announcement of VLMS 5.0, the latest version of ValGenesis' flagship product. VLMS 5.0 boasts an entirely new user interface and a suite of AI-driven functionalities designed to enhance the user experience and streamline validation processes. New features include predictive analytics and AI-powered chatbots for instant support, aimed at reducing manual efforts and improving data accuracy.
The new release also marks a significant step toward a unified platform, integrating various tools such as ValGenesis Process Manager and ValGenesis eLogbook to improve data flow and user experience. This integrated approach aligns with ValGenesis’ vision of smarter validation strategies in line with Industry 4.0 trends, promising ongoing improvements in efficiency, performance, and user-centric design.
Networking and Executive Sessions
ValConnect 2024 was not just about presentations and product announcements; it also offered ample opportunities for networking and leisure. The event kicked off with a special tour of Sintra, the beautiful, historic area of palaces and vistas just outside Lisbon, free for all customers and partners attending the event. This was followed by a welcome reception, providing attendees with a relaxed environment to connect and share experiences.
On day three, the conference concluded with closing comments and an open forum with ValGenesis executives. Siva Samy, Ph.D., CEO and Chief Product Strategist; Narayan Raj, COO; and Jeff Russell, Vice President of Customer Success and Growth, engaged in an open dialogue with the audience, addressing questions about the product portfolio, the company, and future directions. This session provided valuable insights and fostered a deeper connection between the ValGenesis leadership team and its users.
Looking Ahead to ValConnect 2025
As we wrap up ValConnect 2024, we are already looking forward to next year's conference. ValConnect 2025 will be held in the U.S. in the Spring of 2025, with the exact date and location to be determined. Early bird notifications will be sent to all customers and partners in August, and attendees can expect to receive access to the presentation recordings early next week.
We are excited about the continued evolution of ValGenesis’ solutions and the opportunities to connect with our global community of users. Stay tuned for more updates, and we look forward to seeing you at ValConnect 2025!
