Managing Successful Electronic Submissions to the FDA

Webinar description

Join us for a 60 minute discussion between Kyle Boelter and Warren Perry from BIOVIA where they discuss the measures that companies will need to have in place to meet the looming eCTD mandate.  With the US FDA phasing out acceptance of paper based submissions over the next 2 years, things are changing fast, and time is running out to make sure your organization is ready for the brave new electronic world.  They outline what you need to do when preparing electronic dossiers for the FDA, highlighting best practices to ensure accurate submission content to significantly reduce agency approval time.

Areas covered include Content Management and Submission Publishing and the different Lifecycles involved in both processes. They also discuss the impact of 21 CFR Part 11 on your organization from both a qualification and validation perspective, along with the benefits and drawbacks of Cloud solutions and Outsourcing.

Together Kyle and Warren have over 25 years of regulatory and clinical experience, both in industry and with various vendors. 

Featured Speakers

  • Warren Perry, BIOVIA, GRCP Compliance Consultant
  • Kyle Boelter, BIOVIA , Senior Solutions Consultant

Duration: 58 mins

Originally aired: