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Webinar 1:
Start-to-Finish: Submission of Electronic Documents to FDA

  FDA says you have do it: We can Help!
 

You will learn:

  • the basic requirements of the electronic submissions guideline


  • terminology so that you can communicate effectively with your IT people and with FDA


  • how to access and download prepared forms needed for electronic submissions


  • how to use the random number generator to correctly identify each form and different versions of each form


  • how to validate the completed forms


  • how to establish a "gateway" account with FDA


  • the types of communication you will receive from FDA once forms have been submitted


  • areas where there were problems during the initial test and setup of the FDA gateway so you can be prepared for potential issues beforehand.

Duration: 45 min with additional 15 min of Q&A. Total time - 60 minutes

Webinar intro page   •   Webinar #2
  APPROVAL | COMPLIANCE | REGULATORY PROBLEMS
WHO WE ARE | WHY CHOOSE US | CONTACT US
  Phoenix Regulatory Associates, Ltd.® | Phone: 703/406-0906| Toll Free: 888/483-0040
email: phoenix@phoenixrising.com