Part I: The Impact of COVID-19: Complying with Data Integrity Guidelines in the Midst of a Pandemic

A Three-Part FDAnews/CenterWatch Virtual Conference Series

 

COVID-19 has spread across the globe and in an effort to quell the pandemic, the FDA responded with guidelines to expedite effective treatments and devices. They’ve set new regulations meant to hasten the development and approval of products that could prevent, diagnose or treat the virus.

These guidelines, along with the Coronavirus Treatment Acceleration Program, Operation Warp Speed and growing public pressure, have rapidly pushed forward the process of finding solutions to this massive health crisis.

But this swift pace hasn’t absolved manufacturers and researchers of their long-held data integrity responsibilities. While the processes may be moving at a quicker pace, these standards remain steadfast.

Concerned about how you can maintain the same essential data practices during these pressing times? Wondering how it’s possible to succeed in this fast-paced journey while sustaining the crucial standards of success you’ve set for your team?

This three-part FDAnews virtual conference has your answers.

In the first portion, we’ll cover how the FDA’s new guidance impacts data integrity, ways medical product companies are conducting clinical trials during the current pandemic, and how data integrity might change permanently as a result of COVID-19 changes. We’ll also discuss techniques for managing inspections, audits, and supply chain concerns.

Data integrity expert Sue Schniepp will lead conversations and panels around data in the time of COVID-19. She and a group of experts will share tips and examples around altering operations, securing supply chains, and managing clinical trials in the time of a global pandemic. The group will also examine what data integrity’s “new normal” may look like and advice on how organizations can succeed through adjusted inspections and audits.

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