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Aware of the Similarities and Differences in the files

Event Details

Aware of the Similarities and Differences in the files

Time: January 31, 2018 from 10am to 11:30am
Location: Online
Street: 161 Mission Falls Lane, Suite 216,
City/Town: Fremont
Website or Map: http://www.compliance4all.com…
Phone: 18004479407
Event Type: online
Organized By: Adam Fleaming
Latest Activity: Nov 28, 2017

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Event Description

Overview:
It will also consider the European Union's MDD TF/DD requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes.

Why should you Attend:
companies go global, they 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 File or Design Dossier.

Areas Covered in the Session:
DHF "Typical" Contents and Deliverables
The DMR and DHR / Lot / Batch Record
TF / DD Required Contents
Parallel Approaches to Documentation - Teams
FDA and NB Audit Focus

Who Will Benefit:
QA
RA
R&D
Engineering
Production
Operations
Marketing

Speaker Profile:
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.

Event Fee: One Dial-in One Attendee Price: US$150.00

Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: support@compliance4All.com

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