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

Wilmington, Delaware (PressExposure) April 19, 2012 -- 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.

Wednesday, May 23, 2012

10:00 AM PDT | 01:00 PM EDT

Price List:

Live : $245.00

Corporate live : $995.00

Recorded : $295.00

webinars@globalcompliancepanel.com

http://www.globalcompliancepanel.com

Phone: 800-447-9407

Fax: 302-288-6884

About GlobalCompliancePanel

GlobalCompliancePanel is an online training gateway delivering high quality regulatory & compliance trainings in a simple, cost effective and in a user friendly format.


GlobalCompliancePanel offers a broad range of channels for broadcasting and exchange of information through web based training, web alerts & discussion forums.


GlobalCompliancePanel imparts knowledge of best practices in industry to guarantee effective implementation of compliance programs for meeting regulatory demands. The key focus of GlobalCompliancePanel is to provide extensive and quality training for risk management, regulatory compliances, corporate governance and quality management. Apart from providing excellent training to compliance professionals by compliance & consulting experts, GlobalCompliancePanel would also focus on providing:


Information to ensure compliance and enhance quality with regulations for individuals as well as the organizations
Latest updates on industry trends, industry best practices and any modifications in the regulatory affairs
One stop destination for all your queries and to share and discuss issues, ideas and best practices and
A resource on the data sheets, whitepapers, articles, books on industry standards, training kits, software tools, insights, press releases, etc on governance, regulatory, compliances and quality management across different industries.

Press Release Source: http://PressExposure.com/PR/GlobalCompliancePanel.html

Press Release Submitted On: April 19, 2012 at 7:53 am
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