Module 9 2024

03/09/2024

Assay Design & Stats Analysis

Is the assay valid?

Assay Acceptance Criteria (AAC) • If on other hand

AAC

The Organisation for Professionals in Regulatory Affairs

31

31

Assay Design & Stats Analysis

Is the assay valid? • AAC passes… • Apply 2nd line of scrutiny – Sample Suitability Criteria

pass

SSC each sample

AAC

The Organisation for Professionals in Regulatory Affairs

32

32

16