Resources

External links for this lesson. All checked to load from this environment as of the date this page was written. (As with the previous foundation lesson: eCFR’s own rendered pages block automated/proxied traffic here even though a human browser reaches them fine, so the CFR link below is a verified-loading mirror of the same official text rather than the eCFR page itself. The regulation text quoted in this lesson comes straight from eCFR’s public API regardless.)

• Cornell LII: 21 CFR 606.171, current text — Cornell Law School’s Legal Information Institute mirrors the current CFR, including the biological product deviation reporting section (BPDR) quoted in this lesson. Use this to check whether the reporting trigger or the 45-day deadline has changed since this lesson was written; the dated snapshot in this repo’s sources/ folder won’t update automatically.

• ICH Q9(R1): Quality Risk Management — the actual current guideline this lesson’s risk-ranking vocabulary is built on, published by the International Council for Harmonisation. Read the risk assessment section (Section 5, “Risk Assessment”) if you want the source-level definitions of hazard, harm, and risk behind likelihood/severity/detectability — this is guidance-tier methodology, not an FDA regulation, which is exactly the distinction this lesson’s Q1 checks for.

• NIST CSRC Glossary: residual risk — NIST’s Computer Security Resource Center glossary entry for residual risk, useful as a plain, non-GxP-specific definition to cross-check the inherent-vs-residual distinction in this lesson against the same vocabulary as it’s used in security/GRC contexts. Track 4 of this curriculum (grc-frameworks-and-risk-management) will lean on this same NIST vocabulary directly.