Poorti Mohindroo
Managing Director
Dr. Poorti Mohindroo is Managing Director of Forensic Technological Innovation (FTI), the DPIIT-recognised venture incubated at National Forensic Sciences University (NFSU) — an Institute of National Importance. With eight years of experience, she specializes in converting successful R&D prototypes from lab to market. She previously worked with NFSU’s CoE–FTF on pharmaceutical contamination investigation and Q3 characterization of complex generics, and now heads FTI, developing forensic-grade Knapp kits, AVI qualification challenge sets, and CCIT verification standards trusted by 200+ pharmaceutical clients worldwide. A PhD, ISO-qualified lead auditor, and inventor of one utility and one design patent, she has authored four publications and advances both scientific and commercial fronts.
DAY 1: September 28th, 2026
SESSION: Qualifying Detection on the Hardest-to-Inspect Parenterals: Closing the False-Reject Gap
◆ Why AVI qualification can’t be extrapolated: USP <1790> requires detection be proven equal to or better than qualified manual inspection under representative conditions, yet a system validated on clear liquids has demonstrated nothing about the formats that resist inspection.
◆ Where inspection gets hard: how normal variation in lyophilized cakes and powders, suspensions, emulsions, biologics, and amber/molded-glass or polymer containers mimics true defects, a primary driver of the 10–30% false-reject rates reported for difficult-to-inspect products.
◆ Challenge sets that reflect the line, not the lab: format-specific defect design across the visible range (100–3000 µm), with verified morphology and exact placement, derived from real forensic contamination casework rather than generic catalogs.
◆ From qualification to yield and audit-readiness: demonstrating probability of detection per USP <790>/<1790> and EU GMP Annex 1, producing IQ/OQ/PQ evidence with the traceability regulators expect.
