Beyond the Checklist: Smarter Pharmaceutical Validation

Validation in the Pharma Industry remains one of the most scrutinized and inspection-driven elements of GMP compliance. Yet, despite mature systems, validation deficiencies continue to be highlighted during audits or inspections and cited by global regulators. The 2026 edition of iRACI is designed to bridge the gap between regulatory expectations and real-world execution, providing a clear insight into what regulators actually expect from validation programmes.

The session will explore process, cleaning and computerized systems validation, lifecycle validation approach and Continued Process Verification. It will also address how the integration of validation within quality systems shall be done to achieve sustainable compliance. A risk-based approach will be demonstrated using real examples, including the application of effective monitoring tools and meaningful data trending.