Regulatory & Compliance Operations

Navigating FDA, CDC, and HHS frameworks with audit-ready documentation.

Enroll & start

Duration

8 weeks · self-paced

Modules

10 modules · 16h

Credit

16 CLPs

Audience

Compliance officers, QA leads, regulatory affairs staff

Learning outcomes

What you'll be able to do

Map agency activities to FDA, CDC, and HHS regulatory clauses
Build audit-ready evidence packages from day one
Run internal audits that surface findings before external auditors do
Manage CAPA cycles to closure with traceable documentation

Syllabus

Module breakdown

Module 1 — Regulatory landscape
Who regulates what and how authorities overlap.
Module 2 — Documentation systems
Controlled documents, versioning, retention.
Module 3 — FDA inspection readiness
Form 483, warning letters, and how to avoid them.
Module 4 — CDC cooperative agreements
Reporting cadence and performance measures.
Module 5 — HHS grants compliance
Uniform Guidance (2 CFR 200) in practice.
Module 6 — Internal audit program
Annual plan, sampling, finding management.
Module 7 — CAPA management
Root cause, corrective vs preventive actions.
Module 8 — Data integrity (ALCOA+)
Audit trails, electronic signatures, validation.
Module 9 — Training & competency
Tracking qualifications across a workforce.
Module 10 — Capstone audit
Run a mock audit on a sample program.

Course resources

Handouts & references

Branded course materials you can download, print, and share inside your office. All artifacts are versioned with a Regency reference code for audit traceability.

SyllabusRef: RCG-REG-204-SYLPDF · 2 pages
All 10 modules, learning outcomes, and program meta sheet.
Capstone briefRef: RCG-REG-204-CAPPDF · 1 page
Capstone scenario, rubric, and submission expectations.
White paperRef: RCG-WP-REGPDF
Companion reference on building audit-ready operations.

Materials are licensed for internal federal use. Do not redistribute outside your agency.

Regulatory & Compliance Operations

What you'll be able to do

Module breakdown

Module 1 — Regulatory landscape

Module 2 — Documentation systems

Module 3 — FDA inspection readiness

Module 4 — CDC cooperative agreements

Module 5 — HHS grants compliance

Module 6 — Internal audit program

Module 7 — CAPA management

Module 8 — Data integrity (ALCOA+)

Module 9 — Training & competency

Module 10 — Capstone audit

Handouts & references