Building Inspection-Ready Validation for a Digital, AI-Enabled World

About this Webinar

Validation used to be a milestone: qualify the system, sign the report, revisit it years later. That model no longer holds. Cloud and Software as a Service (SaaS) platforms change continuously, AI models need ongoing monitoring, and inspectors increasingly expect live evidence rather than a snapshot from the past. The gap between what regulations require and what many organisations actually do is exactly where risk accumulates.

In this session, Juan Torrijos (Rephine) and Peter Liang (ValGenesis) walk through the full picture of validation in a regulated environment, from the five core disciplines to the regulatory expectations reshaping them. Rather than treating AI as either a threat or a shortcut, they set out a practical, evidence-based view of where it helps and where accountability must stay firmly with people. Throughout, the focus is on staying inspection-ready across UK and EU markets without slowing your business down.

What You’ll Learn

The full validation picture. How Computer System Validation (CSV), Cleaning Validation, Process Validation, Analytical Method Validation and Commissioning, Qualification and Validation fit together as one integrated system rather than five separate exercises.
Why the old playbook is failing. The move away from point-in-time, paper-heavy and reactive validation, and why continuous change in cloud and AI systems demands a different approach.
What regulators now expect. A clear read of EU GMP Annex 11 lifecycle risk management, ICH Q9(R1) risk-based decision making, ALCOA+ as a data integrity design requirement, and current AI guidance.
The five forces reshaping validation. Cloud and SaaS, AI and machine learning, remote execution, live evidence and always-on validation, and what each one changes in practice.
AI in GxP, drawn as a clear line. Where AI can support work such as anomaly flagging, predictive maintenance and protocol drafting, and where it cannot replace human judgement, including batch release, deviation conclusions and regulatory sign-off. We also cover the position on Gen-AI in critical GMP applications, including EMA Draft Annex 22.
Two real field cases. A global Enterprise Resource Planning (ERP) and Manufacturing Execution System (MES) rollout across 12 sites, and the validation of AI-based deviation detection in a GMP setting.
A framework you can act on. The three pillars of modern validation (lifecycle methodology, digital infrastructure and governance) and five moves you can make today.

Who Should Watch

This session is for the people who own the outcome of an inspection and the decisions that lead up to it:

Quality Assurance and Quality Control leaders
Computer System Validation, CSV and validation specialists
Data integrity and compliance managers
Regulatory affairs and GxP professionals
IT and digital transformation leads working in regulated environments
Operations and manufacturing leaders responsible for pharmaceutical or biotech sites

If you are balancing faster digitalisation against tightening regulation, this is built for you.

Featured Experts

Juan Torrijos, Rephine
Pharmaceutical Consultant and VLMS Technical Manager. Juan brings more than 15 years in the life sciences industry, leading CSV, data integrity and internal audit projects in regulated environments. He designs and implements remediation plans and GxP training programmes, and partners with pharmaceutical and biotechnology companies to digitalise their validation processes and move away from paper-based systems.

Peter Liang, ValGenesis
Solution Engineer with more than five years in quality control and cleaning validation. Peter supports validation lifecycle initiatives for pharmaceutical and biopharmaceutical clients and works on integrating AI within ValGenesis’s Validation Lifecycle Management System. He holds a degree in biochemistry from the University of Waterloo.

Press play below to watch the full session, and keep reading for the detail behind each topic.

Agenda

0–2 min
Welcome and introductions

2–8 min
The state of pharma validation

rising fast (Poll 1).

8–13 min
What regulators now expect

13–19 min
Validation as a lifecycle

19–27 min
AI in GxP

27–33 min
Two field cases

33–38 min
Staying ahead

Ready to take the next step?

Wherever you are on your QA journey, we’ve got you covered. If this session raised questions about your own systems, our consultants can help you assess where you stand, close the gaps and build validation that holds up under inspection.

Book a complimentary consultation with a Rephine expert and turn these insights into a plan for your organisation.