Resources: Reviewing deviation and CAPA write-ups

Each link below was checked this session and loads.

• 21 CFR 606.171 — Cornell Legal Information Institute — the reportability test this module’s packet applies (and fails to show its reasoning on): the two-prong test in paragraph (b), and the 45-day reporting clock in paragraph (c). Local verbatim copy: sources/cfr/606.171.md.

• 21 CFR 606.100 — Cornell Legal Information Institute — paragraph (b)(16)’s labeling-safeguards requirement (new to this course) and paragraph (c)’s “conclusions and followup” investigation standard, both central to this module’s reveal. Local verbatim copy: sources/cfr/606.100.md.

• 21 CFR 606.160 — Cornell Legal Information Institute — paragraph (b)(7)(iii), the general-records requirement behind the deviation record itself. Local verbatim copy: sources/cfr/606.160.md.