Ksb D12 K0016

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 change control and validation
2. Apply analyze level cognitive skills to analyze 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

• Change control system design and implementation, computer system validation and regulatory compliance, validation lifecycle management, risk-based validation approaches

Assessment Criteria

• Can analyze 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

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