Remote Regulatory Assessments Will Continue Post Pandemic, Says US FDA
Executive Summary
The US FDA has issued guidance on how it will continue to use remote technology to assess agency regulated facilities, a practice that became popular during COVID-19 travel restrictions.
You may also be interested in...
FDA Revises Guidance On RRAs With Updated Q&As
The FDA has revised draft guidance issued in 2022 on how the agency plans to continue using remote technology to assess regulated facilities. The FDA established remote assessments in early 2021 to keep up its regulatory obligations during the COVID-19 pandemic.
Pre-work Rigor, 'Clean' Documentation Are Key As US FDA Unlocks Remote Inspection Tools
A senior Parexel executive and ex-FDA pharmaceutical quality assessor emphasizes at a conclave why “first impressions matter now more than ever” as the agency deploys complex alternate inspections tools which the pandemic provided, and that companies need to ensure that they get things right the first time.
Pre-work Rigour, 'Clean' Documentation Key As FDA Unlocks Remote Inspection Tools
A senior Parexel executive and ex-FDA pharmaceutical quality assessor emphasizes at a conclave why “first impressions matter now more than ever” as the agency deploys complex alternate inspections tools which the pandemic provided, and that companies need to ensure that they get things right the first time.