September 27
Keynote 8:00 AM
Yes, We Support Digital Transformation
Presented by: Francisco Vicenty (Program Manager, Case for Quality, FDA)
Keynote 9:00 AM
Product Roadmap Vision
Presented by: Kevin D. Shaw (Vice President, Product Management, ValGenesis)
Industry 10:00 AM
Establishment of a Digital QRM Program Using iRisk
Presented by: Ricardo Leandro (Group Product Manager - Risk, ValGenesis)
Product 10:00 AM
What’s New in VLMS 4.2? A Feature Tour
Presented by: Jeff Ramos (Solutions Engineer, ValGenesis)
Industry 10:45 AM
Digital CPV Implementation Real Use Case
Presented by: Sandra Silva (Director, Product Management - CPV, ValGenesis)
Product 10:45 AM
Process Manager: Digitizing the End-to-End Cleaning Validation Lifecycle
Presented by: Sunil Patel (Director - Product Management, ValGenesis)
Industry 11:30 AM
Saving on Signatures – Implementing Digital Test Tracking
Presented by: Steven Swift (Manager Software Systems Engineering, Dexcom)
Product 11:30 AM
CSA in Design Manager
Presented by: Emmanuel Cansino (Senior Director Industry Solutions, ValGenesis)
Product 1:30 PM
iRisk - From Latest Features to Product Roadmap
Presented by: Ricardo Leandro (Group Product Manager - Risk, ValGenesis)
Industry 1:30 PM
Case Study: Digitalizing CSV for Integra LifeSciences
Presented by: Jennifer Zaleski (Senior IS Validation Specialist, Integra LifeSciences)
Industry 2:15 PM
Roundtable: CSA
Presented by: Steve Thompson (Senior Director Product Marketing, ValGenesis)
Product 3:15 PM
A Peek Behind Our UX Curtain
Presented by: Howard Kiewe (Senior Director - UX, ValGenesis)
Industry 3:15 PM
Case Study: Alkermes Transformative Journey to Paperless Validation
Presented by: Josh Neiman (Associate Director, Computer Systems Validation, Alkermes)
Product 4:00 PM
e-Logbook Demo and Discussion
Presented by: Anthony Manzanares (Industry Solutions Engineer, ValGenesis)
September 28
Keynote 8:00 AM
Smart Factories: What Does the Future Look Like?
Presented by: Ângela Martinho (Vice President, Consulting Services, ValGenesis)
Keynote 8:00 AM
Validation 4.0 Makes Pharma 4.0 Credible
Presented by: Dr. Ajaz Hussain, Ph.D. (Pharmaceutical Consultant & Advisory Board Chairman, )
Industry 9:00 AM
Your FDA Inspector Will Love You If You Do This ...
Presented by: Shaun LeBlanc (Senior Director, Professional Services, ValGenesis)
Product 9:45 AM
Using e-Logbook for Manufacturing Logs Unlocks a Treasure Trove of Information
Presented by: Ali Nejat (Project Manager, Professional Service, ValGenesis)
Industry 9:45 AM
Pharma 4.0 - AI/ML Integration in Regulatory Frameworks
Presented by: Sandra Silva (Director, Product Management - CPV, ValGenesis)
Product 10:45 AM
Best Practices in Performing a System Assessment
Presented by: Sandeep Lakshmanan (Sr. Project Manager, ValGenesis)
Industry 10:45 AM
How ChatGPT May Impact the Validation of Computerized Systems
Presented by: Sathish Kumar Shanmugam (Global VP of Customer Advocate, ValGenesis)
Keynote 11:30 AM
The Future Unified Platform of ValGenesis
Presented by: Kevin D. Shaw (Vice President, Product Management, ValGenesis)