Why Your QMS Training Module Isn’t Good Enough
A Data-Driven Analysis of Compliance Failures Across FDA-Regulated Industries
Why Your QMS Training Module Isn’t Good Enough
105 FDA warning letters in FY 2024. The highest in five years. Is yours next?
Training failures are the most consistent deficiency cited in FDA regulatory enforcement. Yet most manufacturers still manage training through fragmented, manual systems that regulators consistently flag as inadequate.
Key Insights
105 FDA Warning Letters in FY 2024. Across pharmaceutical, medical device, and dietary supplement manufacturers, inadequate training and unverified competency are root causes.
Regulators Now Demand Competency Proof. Training attendance is no longer sufficient. Regulators require evidence of competency through integrated systems with automated retraining and complete audit trails.
Most Training Systems Are Fragmented. Only 60% of manufacturers use digital training platforms. Four in ten still manage training manually, the exact systems FDA inspectors flag as deficient.
What’s Inside
This comprehensive whitepaper covers:
- 2024-2025 FDA enforcement data across industries
- Seven specific deficiencies regulators consistently cite
- Real examples from recent FDA warning letters
- Regulatory frameworks (21 CFR 211.25, 21 CFR 820.25, ISO 13485)
- Business impact analysis and cost calculations
- Framework for modernizing your training system
- Actionable recommendations for audit readiness