Ksb D12 K0024

CPA Pathway

• CPA-04

Regulatory References

• FDA-CFR-004
• EMA-REG-001

Instructions

When this skill is activated, Claude should:

1. Demonstrate L1 proficiency in global compliance coordination
2. Apply apply level cognitive skills to apply 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

• Multi-regional compliance management and coordination, cultural adaptation while maintaining global standards, regulatory authority relationship management across jurisdictions, international best practice sharing and implementation

Assessment Criteria

• Can apply core concepts independently
• Demonstrates understanding of regulatory context
• Applies knowledge appropriately to PV scenarios

Related Skills

• Other D12 skills in Inspection Management and Regulatory Authority Relations
• Cross-domain integrations per DAG architecture

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