Aware of the Similarities and Differences in the files

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

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

Schedule of Presentations:

Wednesday, January 31, 2018
3D Tissue Models
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