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Aware of the Similarities and Differences in the files

 
  November 23, 2017  
     
 
Netzealous LLC DBA - Compliance4All, Online
2018-01-31


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


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
 
 
Organized by: Compliance4All
Invited Speakers:

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.
 
Deadline for Abstracts: 2018-01-30
 
Registration: http://www.compliance4all.com/control/w_product/~product_id=501651LIVE?channel=molgen_Jan_2018_SEO
E-mail: support@compliance4All.com
 
   
 
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