Optional paid certificate for the free course Investigating Deviations: From Root Cause to Resolution. The learning is free; this is the graded assessment and the verifiable certificate.
A 31-question exam drawn at random from a substantially larger bank, balanced across all six modules. Pass mark 78%, three attempts, 80 minutes.
What it is not: Cuabity is not affiliated with the FDA, PIC/S or ICH. This certificate is not an accreditation, not a recognised qualification, and not a substitute for employer training or regulatory sign-off — it records that one named person passed one named assessment on one date, verifiable by anyone.
How an investigation is actually conducted — the technique, not the paperwork. Built on the FDA guidance Investigating Out-of-Specification (OOS) Test Results (Level 2 revision, 2022), the most detailed public account of investigation mechanics there is, with PIC/S PE009-18 and ICH Q9(R1)/Q10 behind it.
The two phases, the evidence needed before a result may be discarded, retesting versus testing into compliance, and the three ways an investigation can end.
Free to learn. An optional verifiable certificate is available separately.