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.
The DHF, Technical File and Design Dossier - Similarities, Differences and The Future - Webinar by GlobalCompliancePanel
25 August 2010, Wilmington, DE, United States
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Online Training Webinar
Online Training Webinar, Wilmington, DE, 19801, United States
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GlobalCompliancePanel
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