Скачать или смотреть GDF 2024 | D2S11-1 - Facility Assessment for Pre-Marketing Applications: Inspections and Remote...

This video examined facility assessment approaches for pre-marketing applications, covering both traditional inspections and remote regulatory assessments.

Timestamps

00:14 – Facility Risk Assessment Considerations

03:53 – Compliance Program 7346.832 – Pre-Approval Inspections

06:41 – Remote Regulatory Assessments - Updates

Speaker:

Derek Smith, PhD
Deputy Director
Office of Pharmaceutical Manufacturing Assessment (OPMA)
Office of Pharmaceutical Quality (OPQ)
Center for Drug Evaluation and Research (CDER) | FDA

Learn more at: https://www.fda.gov/drugs/news-events...

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