PDA/FDA 2026 session maps the GMP audit lifecycle, root cause to CAPA closure, plus a local vs. above-site decision framework and two case studies.
|Articles|January 20, 2020
Case Study to Demonstrate Sensitivity in Immunogenicity Assay Should be Based on Result of Both Screening and Confirmatory Tier
Author(s)Syngene
Mahesh Kumar shares background, insights, and results of a study in which a relevant sensitivity and low positive control value in immunogenicity assays are identified.
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