Å·ÃÀAV

Introduction

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.

Useful links

Venue

Online Training Webinar

Online Training Webinar, Wilmington, DE, 19801, United States

Useful links

Organised by

GlobalCompliancePanel

Contact information

Support
United States of America
800-447-9407
Contact us by email

---