Beyond Similarity: How P-Value Material Verification Supports Smarter Pharma Pass/Fail Decisions
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Summary
This webchat explains, in practical language, how a p-value-based multivariate residual approach verifies pharmaceutical raw materials. Instead of asking only whether two spectra look similar, it asks whether the measured differences are still statistically consistent with the approved reference after accounting for normal variation from the instrument, sample, and environment. By evaluating the full Raman fingerprint, estimating uncertainty in real time, and applying a pass/fail rule at p ≥ 0.05, the approach helps QC teams make clearer, more defensible decisions with less subjectivity, simpler method setup, and faster movement from receipt to release.
Speaker
Shailesh Karavadra
Business Development/ Applications Manager
Thermo Fisher Scientific
Shailesh is a Business Development Manager who works with pharmaceutical manufacturing teams on technologies that improve raw material verification, quality decision-making, and operational efficiency. He is passionate about translating complex analytical concepts into practical business value for QC, QA, and procurement stakeholders. In this webchat, he will discuss how p-value-based material verification can support clearer pass/fail decisions, simpler workflows, and better productivity in pharmaceutical manufacturing.
Moderator
