Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), Technical Files , Design Dossiers - The Requirements 2019 is a webinar that covers topics such as:
- Device Classification - U.S. FDA vs. EU MDD
- The EU`s MDD and the Technical File / Design Dossier
- DHF "Typical" Contents and Deliverables
- Design Control `Over Time` vs. a Product`s `Snapshot in Time` - Differing Philosophies
- TF / DD Required Contents
- The DMR and DHR / Lot / Batch Record
- FDA and NB Audit Focus
- Parallel Approaches to Documentation - Teams
Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), Technical Files , Design Dossiers - The Requirements 2019 is intended for:
- QA
- Senior Management in Drugs, Devices, Biologics, Dietary Supplements
- R&D
- RA
- Production
- Engineering
- Marketing
- Operations
