Ksb D09 K0039

• CPA-02, CPA-07

Regulatory References

• FDA-STAT-001
• FDA-CFR-006
• EMA-GVP-009

Instructions

When this skill is activated, Claude should:

1. Demonstrate L3 proficiency in external validation and replication
2. Apply apply level cognitive skills to apply the topic
3. Reference relevant regulatory guidance (FDA-STAT-001, FDA-CFR-006, EMA-GVP-009)
4. Connect to related EPAs: EPA-02, EPA-04, EPA-05

Key Competencies

• Independent validation studies, external database replication, meta-analysis integration, regulatory review preparation

Assessment Criteria

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

Related Skills

• Other D09 skills in Quality Management and Validation Framework
• Cross-domain integrations per DAG architecture

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