Topics
- The EU`s MDD and the Technical File / Design Dossier
- The U.S. FDA`s DHF
- DHF "Typical" Contents
- Design Control vs. a Product `Snapshot in Time`
- Parallel Approaches to Documentation -- Teams
- TF / DD Expected Contents
- FDA and NB Audit Focus
- Future Directions
Who should Attend
QA, Senior management in Drugs, Devices, Biologics, Dietary Supplements, R&D, RA, Production, Engineering, Marketing and Operations.
