Design History Files and Technical Files/Design Dossiers - Meeting U.S. FDA CGMPS and the EU`s MDD Requirements

Design History Files and Technical Files/Design Dossiers - Meeting U.S. FDA CGMPS and the EU`s MDD Requirements is an online event dedicated to the U.S. FDA and EU MDD requirements for DHFs, DMRs, DHRs, and TF/DDs - their formats, content, and their commonalities.

Design History Files and Technical Files/Design Dossiers - Meeting U.S. FDA CGMPS and the EU`s MDD Requirements covers topics such as:

  • 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

Design History Files and Technical Files/Design Dossiers - Meeting U.S. FDA CGMPS and the EU`s MDD Requirements intended for:

  • Senior management
  • Quality Assurance
  • Regulatory affairs
  • Engineering & R&D
  • Production

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