Resources

Three links, each checked this session and confirmed to load.

• ICH Q9(R1), Quality Risk Management (PDF, ICH, final version adopted 18 January 2023). The actual guideline this module is built on: Section 4 gives the Risk Assessment → Risk Control → Risk Communication → Risk Review lifecycle in full, Section 5 covers formality, risk-based decision-making, and managing subjectivity (the R1-specific additions), and Annex I describes FMEA, Risk Ranking and Filtering, and the other named tools. Read this when you want the source itself, not this lesson’s paraphrase of it.

• 21 CFR 606.100, Standard operating procedures — Cornell Legal Information Institute Free, reliably reachable mirror of the regulatory floor this module reuses — paragraph (c)’s “thorough investigation… conclusions and followup” requirement, which underlies any risk-based investigation depth regardless of how formal the process. Use this when you need the regulation’s own wording quickly, without going through eCFR’s blocked rendered pages.

• Title 21 — Code of Federal Regulations — GovInfo The U.S. Government Publishing Office’s official CFR collection, one level up from a single section. Use this as a fallback source, or to browse Part 606 and its neighboring parts directly, when you need to confirm a citation against the government’s own publication rather than a secondary mirror.