Back to the Basics of Computer System Validation | Reconnecting IT • QA • Business in the Era of AI and Cloud Transformation
About This Summit
In an age defined by AI, automation, and cloud technologies, this three-part webinar series revisits the fundamentals of Computer System Validation (CSV) - not to look back, but to strengthen the foundation that enables confident progress.
Each 60-minute session bridges IT, QA, and Business perspectives through practical insights, real-world examples, and regulatory context, ensuring systems remain compliant, reliable, and fit for purpose.
Episode 1 - Building the Foundation
A practical reintroduction to CSV principles, lifecycle stages, and regulatory expectations (FDA 21 CFR Part 11, EU Annex 11, GAMP 5). Learn how risk-based validation and critical thinking create a shared understanding across IT, QA, and Business.
Episode 2 - Data Integrity and the Cloud
Explore how to maintain control, traceability, and compliance in cloud and SaaS environments. Discover how a mature QMS can act as a governance backbone for supplier oversight, risk-based assurance, and agile cloud adoption.
Episode 3 - The Future of Validation
See how Computer Software Assurance (CSA), critical thinking, and AI-driven tools are transforming validation from a document-heavy exercise into a forward-looking assurance discipline that balances innovation and compliance.
Join us to reconnect the essentials of validation with the realities of today’s digital transformation - and build the confidence to move forward.
Each 60-minute session bridges IT, QA, and Business perspectives through practical insights, real-world examples, and regulatory context, ensuring systems remain compliant, reliable, and fit for purpose.
Episode 1 - Building the Foundation
A practical reintroduction to CSV principles, lifecycle stages, and regulatory expectations (FDA 21 CFR Part 11, EU Annex 11, GAMP 5). Learn how risk-based validation and critical thinking create a shared understanding across IT, QA, and Business.
Episode 2 - Data Integrity and the Cloud
Explore how to maintain control, traceability, and compliance in cloud and SaaS environments. Discover how a mature QMS can act as a governance backbone for supplier oversight, risk-based assurance, and agile cloud adoption.
Episode 3 - The Future of Validation
See how Computer Software Assurance (CSA), critical thinking, and AI-driven tools are transforming validation from a document-heavy exercise into a forward-looking assurance discipline that balances innovation and compliance.
Join us to reconnect the essentials of validation with the realities of today’s digital transformation - and build the confidence to move forward.
Meet The Presenters
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GxP-CCGet the Customized GxP Compliance Strategy You Need In the Pharmaceutical, Medical and Dental Industries -
Justo EspinosaPartnerJusto J. Espinosa is the Operations Officer at GxP-CC, with over 17 years of experience in the consulting industry. Before entering the private sector, Justo spent 10 years in the US Government service.
Justo’s career in consulting began over 17 years ago, and since then, he has gained a wealth of experience in a variety of roles. At GxP-CC, he is responsible for overseeing all aspects of the organization’s operations, including finance management, team support, customer engagements, consulting services, team member training, and professional services automation. Justo is passionate about advancing processes throughout the organization and ensuring that GxP-CC is delivering on its commitments to clients.
As second-in-command to the organization, Justo acts as a liaison to the founder and CEO, always looking for ways to improve the organization’s operations. Justo’s passion for sharing his knowledge and expertise has led him to conduct many training events and workshops with customers, and he takes pride in seeing his team members succeed and grow.
Justo’s commitment to helping his team members succeed, combined with his extensive experience in the consulting industry and previous experience in the US Government service, make him a valuable member of the GxP-CC team. He holds an MBA from Colorado Technical University and a Certificate in Global Management from INSEAD’s executive education program. Justo’s dedication to delivering the highest quality services to clients has helped to make GxP-CC a leader in the life science compliance industry.
Sessions in this Summit
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Back to the Basics of CSV Ep.1: Introduction to Computer System Validation (CSV) | Building the FoundationThursday, November 13, 2025 · 4:00 PM CET
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