Validation in the New Pharma Reality: Compliance, Digitalisation and AI Under Rising Regulatory Pressure

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Six months before an FDA inspection, a vendor update hits 60 of your 180 validated interfaces. Revalidation is not due for another 14 months. Would you know how to respond, and how to defend it?

Regulators have moved on from point-in-time, paper-based validation. In this on-demand webinar, Rephine and ValGenesis show you what modern, inspection-ready validation looks like when cloud systems change constantly and artificial intelligence (AI) enters GxP processes.

What you’ll learn:
  • Why the traditional validation model is falling behind, and where compliance risk quietly builds up
  • What regulators now expect across EU GMP Annex 11, ICH Q9(R1) and ALCOA+ data integrity
  • Where AI can genuinely support GxP work, and where human oversight remains a hard requirement
  • How a lifecycle approach keeps you inspection-ready across UK and EU markets
  • Five practical moves your team can make straight away

Speakers

1

Juan Torrijos, Pharmaceutical Consultant and VLMS Technical Manager at Rephine, with over 15 years in Computer Systems Validation (CSV), data integrity and GxP training.

2

Peter Liang, Solution Engineer at ValGenesis, specialising in validation lifecycle management and the integration of AI into validation projects.

Complete the form now to unlock the full recording and see how leading teams are rebuilding validation for a digital, AI-enabled world. It takes less than a minute, and access is instant.

Watch the Webinar

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