DHF, DMR, DHR, Technical File and Design Dossier - Key Requirements and Future Directions

Product Id : 600473

Globalcompliancepanel

Training Options

  •   Duration: 90 Minutes  
  • Recorded Access recorded version only for one participant; unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
    Price: $295.00
  • Refund Policy

Overview:

This webinar will examine the existing and proposed requirements for the FDA's DHF - including its derivative documents, the DMR and DHR.

It will consider the MDD's TF/DD requirements, and evaluate the documents' differing purposes / goals. Required and desirable contents will be discussed. Also considered: Areas requiring frequent re-evaluation / update; Similarities and differences; 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. Finally, the differing approaches to file audits by the FDA and the Notified Body will be discussed.

Why you should attend: Increasingly U.S. companies are going global and must meet different product design documentation. The cGMPs mandate Design Control and the Design History File (DHF).  In order to sell globally, the EU's CE-marking documentation is a requirement - the Technical FiIe or Design Dossier. Currently they serve different purposes, support different goals, but the TF/DD is moving in the direction of the DHF. And the DHF is adapting to some of the features of the TF/B9DD. Being aware of the similarities and differences can further concurrent development and/or updates to both

Areas Covered In the Session:
  • The U.S. FDA's DHF
  • The EU's MDD and the Technical File / Design Dossier
  • Design Control 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
John E. Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management, U.S. FDA responses. In addition, he has successfully designed, written and run all types of process, equipment and software qualifications/validations, which have passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles, and workshops, world wide. John has also managed pilot production, regulatory affairs, product development/design control, 510(k) submissions, risk management per ISO 14971, and projects; with over 28 years of experience in the FDA-regulated medical products industry - working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco/Mallinckrodt. He is a graduate of UCLA.


Related Webinars:

No Related Webinars Available


About Us

GlobalCompliancePanel is a training source that delivers diverse, high quality regulatory & compliance trainings. These trainings are simple while being relevant and cost-effective while being convenient.

Contact Us

NetZealous LLC,
161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA.
  Phone: +1-800-447-9407
  Fax: 302 288 6884
     Copyright © 2014 GlobalCompliancePanel. All rights reserved. Netzealous
USAePay
Back to Top