Ksb D12 K0014

---
name: ksb-d12-k0014
title: 'KSB-D12-K0014: Regulatory Compliance Framework'
description: 'Regulatory Compliance Framework: Compliance risk assessment and management, audit readiness and inspection preparation, corrective ac...'
author: nexvigilant
author_url: https://github.com/nexvigilant/.true/tree/main/knowledge/pv-ksb/ksb-d12-k0014-regulatory-compliance-framework
license: MIT
version: 0.1.0
execution_mode: open
jurisdiction: general
practice: regulatory
language: en
---

# KSB-D12-K0014: Regulatory Compliance Framework

## Overview
**Domain:** D12 - Industry & Regulatory
**Type:** Knowledge
**Proficiency Level:** L4 (Proficient - Independent practice)
**Bloom Level:** Evaluate

## Description
Compliance risk assessment and management, audit readiness and inspection preparation, corrective action and preventive action (CAPA) system optimization, compliance culture development and organizational behavior

## Context
- **Major Section:** Global Regulatory Framework Architecture and Strategic Organizational Response
- **Section:** Quality Management System Architecture and Excellence

## EPA Mapping
- EPA-06:3013-3015
- EPA-09:3020-3022
- EPA-16:3035-3036

## CPA Pathway
- CPA-04

## Regulatory References
- FDA-CFR-004
- EMA-REG-001

## Instructions

When this skill is activated, Claude should:

1. **Demonstrate L4 proficiency** in regulatory compliance framework
2. **Apply evaluate level** cognitive skills to evaluate the topic
3. **Reference** relevant regulatory guidance (FDA-CFR-004, EMA-REG-001)
4. **Connect** to related EPAs: EPA-06, EPA-09, EPA-16

### Key Competencies
- Compliance risk assessment and management, audit readiness and inspection preparation, corrective action and preventive action (CAPA) system optimization, compliance culture development and organizational behavior

### Assessment Criteria
- Can evaluate core concepts independently
- Demonstrates understanding of regulatory context
- Applies knowledge appropriately to PV scenarios

## Related Skills
- Other D12 skills in Quality Management System Architecture and Excellence
- Cross-domain integrations per DAG architecture

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*Generated from PV KSB Framework v1.0 | 2025-12-31*