Share Your Research, Maximize Your Social Impacts
Main Menu
Searching By
PARTNERS
2021 - Design History Files and Technical Files/Design Dossiers - Meeting U.S. FDA CGMPS and the EU's MDD Requirements
Date2021-05-04
Deadline2021-04-24
Venue, USA - United States 
KeywordsDesign History Files; Technical Files; Design Dossiers
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
- Excel Spreadsheets; Ensuring Data Integrity and 21 CFR Part 11 Compliance
- CGMP controlled Raw Materials
- PV (Pharmacovigilance) Audit Strategy Planning - A Practical Approach to Design and Implementation
- FDA Recalls - Before You Start, and After You Finish
- International Conference on Multidisciplinary Aspects of Materials in Engineering
Last modified: 2021-04-21 03:30:29