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The Agile methodology has significantly changed software development by increasing collaboration through iterative releases shared amongst stakeholders. This approach has resulted in quicker release cycles and improved product quality. Given the benefits of Agile development, the same approach can be applied to validation to overcome the limitations inherent to the Waterfall methodology and other traditional CSV validation approaches. This session will teach you how to use the Agile methodology within the ValGenesis VLMS platform.

How the FDA is collaborating to enable a highly connected device ecosystem to strengthen product quality, innovation, and safety.

Smart is mental alertness, resourcefulness, elegance, and stylishness, characterized by quickness and ease in learning. However, the title ValGenesis SMART envisions and speaks to much more value to be realized in paperless validation lifecycle management. This talk focuses on continually improving the ValGenesis platform and services to explore and explain why, in the Industry 4.0 revolution, the need and emphasis on assessing the maturity of professionals and management systems, particularly quality management systems, is increasing.

As life sciences companies continue to digitize their processes, the need for digital tools to help them manage the intricacies of digitalization is increasing. This session will highlight how ISPE GAMP 5 (Second Edition) requirements are configured out of the box through the CSA-ready ValGenesis 4.2 system. Presenter Steve Thompson will discuss why the industry struggles with risk management, requirements management, and formalized testing.

This keynote explores how leading life sciences companies Roche and Genentech rose to meet the challenges posed by the COVID-19 pandemic using the ValGenesis VLMS.

In this session, Director of Professional Services Yowvanaraj Gopal will explain how to connect the ValGenesis VLMS to other GxP software systems to maximize data sharing and workflow efficiency for lean validation. Special focus will be placed on integrating IT service management tools like ServiceNow and Jira.

Join Nancy Cattle, VP of Learning Services, for a live demonstration of ValGenesis University, our next-level learning and development platform. ValGenesis University leverages the latest technology and creative instructional techniques to provide an innovative online learning experience for new users and seasoned pros.

In our post-pandemic world, digital transformation and cultural transformation are inextricably linked. This session explores how to leverage a digital tool like ValGenesis to increase employee engagement and establish a strong culture of performance, both of which are critical to Pharma 4.0 success.

Digitalization can be a boon for continued process verification of new and legacy products. In this session, Sanjay Sharma, Vice President & Global Head of Technology Transfer at Lupin, a fast-growing generic pharmaceutical company based in Mumbai, draws on his decades of experience to discuss a broad range of CPV-related topics.

Templates are a great way to save time, boost productivity, and guarantee consistency. They give your documents a uniform look and feel that’s attractive to auditors. This session will cover everything you need to know about creating and using templates in ValGenesis.

Digital transformation is the new normal! Join us for a live demonstration of ValGenesis e-Logbook, our web-based digital logbook application. Going digital with ValGenesis e-Logbook will simplify your life and help you produce high-quality data that’s easy to defend during an audit or inspection.

In this session, Robert van der Laan, Senior Vice President of Professional Services, will share best practices gleaned through years of successful customer implementations. Robert will demonstrate how incorporating these best practices into your implementation project can save you time and money and increase project success.

Join Sunil Patel, ValGenesis' Director of Product Management, for a live demonstration of our new cleaning validation solution, designed to help you develop robust cleaning programs that manage risk and ensure the safety and efficacy of products from development through manufacturing. During this session, you'll learn the many benefits of digitizing your data and automating your cleaning validation processes.

Dr. Reddy’s Laboratories, a leading multi-national pharmaceutical company, uses ValGenesis for all of their CSV projects and recently expanded their use to include equipment qualification. Join Rajesh Thempadiyill, Head of Quality Digital Transformation & Compliance, as he shares Dr. Reddy’s digital transformation roadmap and how ValGenesis fits into the company’s future plans.

Philips implemented ValGenesis globally to support their standardized software validation process for quality management system software. Learn about their journey from a customized branch to the main branch in Version 4.1 and the challenges they overcame with end-to-end requirements traceability and split execution testing.