Resources

This module cites no new regulation, guidance, or standard — it’s a synthesis exercise, combining evidence this course already built in depth, the same handling designing-an-internal-audit-program’s own resources page gave its own synthesis-only module. Nothing below is quoted in this lesson. These links point back to the primary sources this course has already verified and cited at length, so you can go straight to the actual text behind today’s two re-referenced phrases, rather than a brand-new search for sources this module doesn’t need.

• Cornell LII: 21 U.S.C. § 374 — reused from fda-inspection-authority-and-outcomes. The full statutory text behind 374(a)(1)’s inspection authority and 374(b)(1)’s written-report requirement — the actual legal basis for everything the morning, FDA-style mock session can ask to see.

• AABB: Accreditation Process — reused from the-aabb-assessment-process. AABB’s own public description of its two-phase process, including the “PPPs… followed as written” sentence this module’s afternoon session is built around. Read it for the full context this module only re-references in one line.

• Cornell LII: 21 CFR § 606.160 — reused from data-integrity-and-records. The full text of 606.160(e), including the “at least monthly” floor this module’s cadence decision is measured against. This course never quoted (e) in full itself; read it here if you want the actual regulatory floor behind Lakeshore’s own weekly decision, not just this module’s paraphrase of it.

If you want the general, non-regulatory background on how a mock inspection or mock audit is typically run in a regulated industry, ASQ’s (American Society for Quality) own public materials on internal-audit program maturity are a reasonable starting point — the same industry-practice tier designing-an-internal-audit-program already drew on, described there in this curriculum’s own words rather than quoted or cited to a specific body-of-knowledge section number.