Design History Files and Technical Files/Design Dossiers - Meeting U.S. FDA CGMPS and the EU`s MDD Requirements 2019 is an event dedicated to the U.S. FDA and EU MDD requirements for DHFs, DMRs, DHRs, and TF/DDs - their formats, content, and their commonalities.
Topics
- The U.S. FDA`s DHF
- Design Control `Over Time` vs. a Product `Snapshot in Time`
- The EU`s MDD and the Technical File / Design Dossier
- TF / DD Expected Contents
- DHF "Typical" Contents
- The DMR and DHR -- DHF "Deliverables"
- Parallel Approaches to Documentation -- Teams
- FDA and NB Audit Focus
- Some Future Trends to Consider
Who should Attend
- Senior management
- Quality Assurance
- Regulatory affairs
- Engineering & R&D
- Production
