Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), Technical Files , Design Dossiers - The Requirements 2019

Topics

• 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

Who should Attend

• QA
• Senior Management in Drugs, Devices, Biologics, Dietary Supplements
• R&D
• RA
• Production
• Engineering
• Marketing
• Operations