Electronic Systems, Electronic Records, and Electronic Signatures Webinar
Вставка
- Опубліковано 26 кві 2023
- Video Description
In this video, FDA presented the current thinking regarding 21 CFR 11 and its application to electronic records, electronic systems, and electronic signatures during a clinical investigation.
Timestamps
00:59 - Introduction
07:01 - Overview of Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers
17:55 - Regulatory Expectations regarding 21 CFR 11 during GCP inspections
40:00 - Q&A Discussion Panel
Speakers:
Leonard Sacks, MBBCh
Associate Director
Clinical Methodologies
Office of Medical Policy (OMP) | CDER | FDA
Elizabeth Kunkoski, MS
Health Science Policy Analyst
Clinical Methodologies
OMP | CDER | FDA
Kassa Ayalew, MD, MPH
Director
Division of Clinical Compliance Evaluation
Office of Scientific Investigation | CDER | FDA
Panelists:
Speakers mentioned above
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