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Subscribe NewsletterThe DHF, Technical File and Design Dossier - Similarities, Differences and The Future
Product Id
:
600223
Overview: This webinar will examine the existing and proposed requiements for the FDA's DHF and the MDD's TF/DD. Differing purposes / goals.
Differing purposes / goals. Required and desirable contents. Areas requiring frequent re-evaluation / update. Similiarities and differences, and future trends. Typical DHF Table of Contents. Technical File or Design Dossier Table of Contents. The importance and usefulness of the "Essential Requirements". Structure of the "Declaration of Conformity"; self-declaring or N-B reviewed. Parallel approaches to development. Differing approaches to file audits by the FDA and the Notified Body.
Differing purposes / goals. Required and desirable contents. Areas requiring frequent re-evaluation / update. Similiarities and differences, and future trends. Typical DHF Table of Contents. Technical File or Design Dossier Table of Contents. The importance and usefulness of the "Essential Requirements". Structure of the "Declaration of Conformity"; self-declaring or N-B reviewed. Parallel approaches to development. Differing approaches to file audits by the FDA and the Notified Body.
Areas Covered in the Session:
- The EU's MDD and the Technical File / Design Dossier
- Design Contol vs. a Product 'Snapshot in Time'
- DHF "Typical" Contents
- TF / DD Expected Contents
- Parallel Approaches to Documentation - Teams
- Future Directions
- FDA and NB Audit Focus
Who Will Benefit:
- Senior management in Drugs, Devices, Biologics, Dietary Supplements
- QA
- RA
- R&D
- Engineering
- Production
- Operations
- Marketing