Resources: Deviations and nonconformances

Each link below was checked this session and loads.

• 21 CFR 606.100 — Cornell Legal Information Institute — the SOP-requirement regulation, including paragraph (b)’s clause on written procedures for product-deviation investigations, quoted in this lesson. The local verbatim copy used here lives at sources/cfr/606.100.md.

• 21 CFR 606.171 — Cornell Legal Information Institute — the biological product deviation reporting rule this lesson applies to Owen Pruitt’s donation. Already the full subject of the risk-and-controls-vocabulary foundation lesson; use this as a stable, citable mirror of the same text. Local copy: sources/cfr/606.171.md.

• 21 CFR 630.10 — Cornell Legal Information Institute — general donor eligibility requirements, including paragraph (h) (must not collect from a deferred donor) and the travel-history eligibility factor in paragraph (e)(2)(iii), both quoted or cited in this lesson. Local copy: sources/cfr/630.10.md.

• GovInfo: Code of Federal Regulations collection — the U.S. Government Publishing Office’s official CFR collection, useful as a fallback primary source if a specific eCFR or Cornell page is ever unreachable, and for pulling an official PDF of a full CFR part when you need one for the record.