Welcome to day one of ValConnect 2022! We’re off to a great start and thrilled to tell you all about it. For those unfamiliar with the event, ValConnect is our annual global user conference. It unites the entire ValGenesis community — customers, partners, employees, and industry thought leaders — to share their insights on life sciences trends, validation and compliance best practices, and how we can improve our use of ValGenesis.
Today, hundreds of virtual attendees took part in some genuinely invaluable learning experiences. With two tracks available — Industry Insights and Product Knowledge — the sessions offered something for everyone, from new users to seasoned pros. Read on for a recap of day one.
Keynotes
ValGenesis Vision and Roadmap
Today featured a brilliant and inspiring lineup of keynote speakers. ValGenesis CEO and Chief Product Strategist Dr. Siva Samy kicked off this year’s conference with an overview of 2022 and the product roadmap for 2023 and beyond. The company experienced phenomenal growth this year, tripling R&D resources to support new product development and adding four new products to its portfolio, two of which (iRISK™ and iSEE™) came from its acquisition of 4Tune Engineering (4TE) in June.
Because ValGenesis’ goal is to offer customers a unified digital platform to manage product lifecycle from design and qualification to CPV, it will continue to expand its roadmap beyond core validation into validation-driven product lifecycle management. As Dr. Siva stressed, future development will be prioritized based on customer needs because customer success is ValGenesis’ number one priority.
ValGenesis CTO Mike Hicks joined the keynote to discuss three core roadmap themes: the future of digital validation; the importance of providing value across the entire validation lifecycle; and new advancements the company is working on to help customers cross the Validation 4.0 chasm, i.e., move from a document mindset to a continuous validation mindset, to gain a substantial competitive advantage.
As committed as the company is to innovation and meeting future needs, Hicks made it clear that it is equally committed to continually improving the capabilities and scalability of existing products. ValGenesis VLMS v4.2, slated for release in Q4 2022, features over 100 customer-driven product improvements and a Design Manager module with enhanced risk management capabilities that are aligned with the newly released CSA guidance.
Roche/Genentech
The day's second keynote was delivered by Sathish Kumar Shanmugam, IT product manager at Roche, and Shawn Phillips, business application manager at Genentech, a Roche subsidiary. They walked attendees through their digital transformation journey to a fully paperless system with humor and candor, discussing the challenges they faced as a large, multi-site organization. They offered valuable tips for overcoming resistance to change and stressed the importance of being willing to take a step back, i.e., spend time and energy perfecting and harmonizing business processes, to take a giant leap forward. By standardizing and harmonizing validation templates across sites, the team has reduced time spent on non-value-added activities by at least 50%. These efficiency gains have allowed them to reallocate resources to prioritize innovation and get products to market sooner.
Aside from the keynotes, there were plenty of exciting breakout sessions.
Monday’s Session Highlights
Here are some high-level takeaways from today’s 45-minute sessions. We plan to feature many of these sessions and links to their recordings in upcoming blog posts.
Session: CPV for New and Legacy Products: Linking Continuous Improvement to Process Performance
Sanjay Sharma, vice president and global head of technology transfer at Lupin, delivered a well-received Industry Insight session on the impact of digitization on continued process verification (CPV) of new and legacy drug products. Sanjay covered a variety of relevant and timely CPV-related topics, including data-driven strategies to determine the quality of legacy products, how to develop a risk-based CPV monitoring plan for both new and legacy products, and the ways in which COVID-19 has accelerated the need for digital CPV.
Session: Introduction to iRISK™ and Quality Risk Management from 4TE
Ana Margarida Ventura, quality risk management tech lead at 4TE, treated attendees to a live demo of the iRISK Platform®, used by 10 of the top 30 global life sciences companies. She showed users how to identify, quantify, and prioritize risks and create risk mitigation and control strategies for new and existing assets. Learn more about the features and functionality of iRISK.
Session: Adopting a Risk-Based Lifestyle Approach to GxP Computerized Systems with ValGenesis VLMS 4.2 (with GAMP 5 E2 and CSA Perspectives)
FDA’s CSA guidance was just released, but Steve Thompson, ValGenesis’ director of industry solutions, has been writing and speaking about it for years. Today, Steve discussed the need for a robust risk management program to meet evolving requirements and standards like CSA and ISPE GAMP 5 E2. Steve explained how the CSA-ready ValGenesis system could help regulated companies meet those requirements and standards out of the box.
Session: How to Manage Logbooks Electronically – from Paper to Cloud
In our second live demo of the day, Sophia Vraka, senior solutions engineer, demonstrated the features and capabilities of ValGenesis e-Logbook, a new product released in April of 2022. The purpose-built digital logbook application is Part 11/Annex 11 compliant and can scale to thousands of users across multiple sites. It fully replaces traditional paper logbooks, which expose teams to inefficient processes, illegible or incomplete information, lost logbooks, contamination, and other compliance risks.
On tap for tomorrow: more great sessions, live demos, and a keynote from Cisco Vicenty, program manager of the FDA’s Case for Quality initiative. Cisco will discuss how the FDA collaborates to enable a highly connected device ecosystem to strengthen product quality, innovation, and safety.
Save the Dates for ValConnect 2023!
If you’d like to participate in similarly insightful educational opportunities while also benefiting from the great networking opportunities available at ValConnect, plan on attending next year’s in-person event at the Hilton Clearwater Beach Resort & Spa in Clearwater, Florida, Sept. 26-28.
