Aware of the Similarities and Differences in the files

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Category Design Dossiers Webinar, 2018 medical trainings, Dietary Supplements, Regulatory Trainings, advanced medical designs, Online Device Master Records Operations

Deadline: January 30, 2018 | Date: January 31, 2018

Venue/Country: Online, U.S.A

Updated: 2017-11-29 15:29:56 (GMT+9)

Call For Papers - CFP

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: supportcompliance4All.com