San Francisco Events

Aware of the Similarities and Differences in the files


Jan 31, 2018 – 10:00 AM - 11:30 AM

Online Event
San Francisco, CA 94103 Map

More Info

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:

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.

Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
One Dial-in One Attendee Price: US$150.00

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