June 18
Industry 8:15 AM
Validation 4.0
Presented by: Ângela Martinho (Vice President, Consulting Services, ValGenesis)
Product 9:00 AM
Portfolio Review and Product Roadmap
Presented by: Kevin D. Shaw (Vice President, Product Management, ValGenesis)
Customer 9:45 AM
Embracing Change: Otsuka's Journey Through CSA in the Era of Digital Transformation
Presented by: Dr. Imtiaz H. Mohiuddin M.B.A, Ph.D. (Senior Director, Global Quality Solutions (GQS), Otsuka)
Product 11:45 AM
AI and Beyond: What's New in VLMS 5.0
Presented by: Sophia Vraka (Senior Solutions Engineer, ValGenesis)
Industry 1:30 PM
CSA and CAPAs: Two Products of Risk Management
Presented by: Daniel Walter (Policy Analyst, Compliance and Quality Staff, FDA)
Customer 2:15 PM
Implementing iRisk for Effective Knowledge and Risk Management at Boehringer Ingelheim
Presented by: Susanne Weiler (Senior Risk Manager, Pharmaceutical Development Biologicals, Boehringer Ingelheim)
Customer 3:30 PM
From Standards to ValGenesis – Becoming Fully Digital in Validation & Qualification
Presented by: Sigrun Seeger (Global Process Manager ValGenesis, GPO GxP Computerized System Life Cycle, Bayer), Verena Buhl (GPO Validation and Qualification, GPO ValGenesis, Bayer)
Product 5:00 PM
Revolutionizing Validation Strategies: Integrating CSA Draft Guidance Through VLMS Design Manager Module
Presented by: Emmanuel Cansino (Senior Director Industry Solutions, ValGenesis)
June 19
Customer 8:00 AM
Digital Transformation: Implementation of Global Paperless Validation and Qualification System
Presented by: Mani Palaniappan (MSAT Validation Expert, Roche Singapore, Roche)
Industry 8:45 AM
Risk-Based Cleaning Validation
Presented by: Rui Almeida (Director - Consulting Services, ValGenesis)
Customer 9:30 AM
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
Presented by: Dr. Iris Ziegler (Director QbD & Pharmaceutical Sciences, Corden Pharma)
Industry 10:45 AM
How Generative AI May Impact the Validation of Computerized Systems
Presented by: Sathish Kumar Shanmugam (Global VP of Customer Advocate, ValGenesis)
Product 11:30 AM
The Impact of AI and ML in Quality Risk Management
Presented by: Ricardo Leandro (Group Product Manager - Risk, ValGenesis)
Product 12:15 PM
AI-Driven, Real-Time Monitoring Toward Predictive Analysis and Enhanced Quality: A Practical approach
Presented by: Sandra Silva (Director, Product Management - CPV, ValGenesis)