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2019 - Design History Files and Technical Files/Design Dossiers - Meeting U.S. FDA CGMPS and the EU's MDD Requirements
Date2019-05-07
Deadline2019-05-07
VenueOnline Event, USA - United States 
KeywordsDesign History Files; Device Master Records; Device History Records
Topics/Call fo Papers
The U.S. FDA's DHF
The EU's MDD and the Technical File / Design Dossier
Design Control 'Over Time' vs. a Product 'Snapshot in Time'
DHF "Typical" Contents
TF / DD Expected Contents
Parallel Approaches to Documentation -- Teams
The DMR and DHR -- DHF "Deliverables"
Some Future Trends to Consider
FDA and NB Audit Focus
The EU's MDD and the Technical File / Design Dossier
Design Control 'Over Time' vs. a Product 'Snapshot in Time'
DHF "Typical" Contents
TF / DD Expected Contents
Parallel Approaches to Documentation -- Teams
The DMR and DHR -- DHF "Deliverables"
Some Future Trends to Consider
FDA and NB Audit Focus
Other CFPs
- Stability Studies and Estimating Shelf Life
- Scrutinizing Test Method Validation (TMV) to Verify the Performance of a Medical Device
- AML Model Validation: A Critical Need in the New Regulatory Environment
- Handling Payroll Overpayments Correctly
- Handling OOS Test Results and Completing Robust Investigations
Last modified: 2019-04-07 23:15:24