Aware of the Similarities and Differences in the files

6 years ago Posted By : User Ref No: WURUR15386 0
  • Image
  • TypeWebinar
  • Image
  • Location Fremont, California, United States
  • Price
  • Date 31-01-2018
Webinar Title
Aware of the Similarities and Differences in the files
Event Type
Webinar
Webinar Date
31-01-2018
Last Date for Applying
30-01-2018
Location
Fremont, California, United States
Organization Name / Organize By
Netzealous LLC DBA - Compliance4All
Organizing/Related Departments
Trainings for all Industries
Organization Type
Organization/Company
WebinarCategory
Both (Technical & Non Technical)
WebinarLevel
All (State/Province/Region, National & International)
Related Industries

Education/Teaching/Training/Development

Information Technology

Accounting/Financial/Banking/Insurance

Medical/Healthcare/Hospital

Location
Fremont, California, United States

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.

Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: [email protected]

Others Details

For more details and updates please visit website.

Registration Fees
Available
Registration Fees Details
One Dial-in One Attendee Price: US$150.00
Registration Ways
Email
Phone
Website
Address/Venue
  Online 
Official Email ID
Contact
Event Manager

Netzealous LLC DBA - Compliance4All 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA. Phone: +1-800-447-9407 Email: [email protected]

[email protected]

     18004479407
   Fax No: 302-288-6884