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THE ONLY CONFERENCE IN EUROPE COMPLETELY DEDICATED TO TRIAL MASTER FILES! 3RD ANNUAL EUROPEAN TRIAL MASTER FILE SUMMIT Maintaining a Compliant Electronic and Paper IMF for Audits and Inspections 2021
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What is tmf - exl events?
TMF-EXL events refer to the submission of manufacturing and quality events to the FDA through the FDA's electronic submission gateway.
Who is required to file tmf - exl events?
Manufacturers, packers, and labelers of drug products are required to file TMF-EXL events.
How to fill out tmf - exl events?
TMF-EXL events are filled out using the FDA's electronic submission gateway.
What is the purpose of tmf - exl events?
The purpose of TMF-EXL events is to report manufacturing and quality events related to drug products to the FDA.
What information must be reported on tmf - exl events?
Information such as manufacturing deviations, quality control failures, and drug product recalls must be reported on TMF-EXL events.
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