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.
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Responses to US FDA draft guidance suggest more promptness while also more elaborate processes for agency decision making based on remote methods. Questions include what’s voluntary, what’s mandatory, what can be decided remotely, and how to remotely move on from warning letters.
Time To Focus On GMP Activities Deferred By Pandemic, CDER Compliance Director Says
US FDA’s Donald Ashley recaps the past year’s precedent-setting responses to the COVID-19 pandemic in Pink Sheet interview, while outlining a return to pre-COVID priorities and traditional inspection-based oversight.
Remote Regulatory Assessments Will Continue Post Pandemic, Says US FDA
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.