Regulatory Submission Module 1: Setting the Strategy for Your Company’s Submission Process

This module provides the overarching strategy for how the regulatory professional develops the most effective submission process for each new product.  Topics covered include: knowing where and when to begin, involvement of other functional areas, overview of the submission components, and available online FDA resources.
 

Expert Faculty

April Veoukas
Director, Regulatory Affairs
Abbott

(Expert faculty titles and companies may have changed since the time of recording.)
 

Level

Intermediate
 

Learning Impact

Upon completion of this training, participants will:

  • Understand where their regulatory pathway begins, and how to successfully reach the end
  • Identify the cross functional partners and stakeholders whose input is vital to their 510 (k) submission
  • Pinpoint the most critical components of a 510(k)
  • Learn how to employ various FDA resources


Certification

Certificate of Completion: Each participant will receive a Certificate of Completion for .1 CEUs upon viewing the webinar course and returning a completed evaluation form.

 

Price

$99 per module
$500 for entire series (Receive a 15% discount for purchasing all six modules)