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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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TMF-EXL events refer to the submission of manufacturing and quality events to the FDA through the FDA's electronic submission gateway.
Manufacturers, packers, and labelers of drug products are required to file TMF-EXL events.
TMF-EXL events are filled out using the FDA's electronic submission gateway.
The purpose of TMF-EXL events is to report manufacturing and quality events related to drug products to the FDA.
Information such as manufacturing deviations, quality control failures, and drug product recalls must be reported on TMF-EXL events.
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