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Training Medical Informatics : Preparation of FDA Submissions and Communicating with the FDA | Seminar 2018
Course "Preparation of FDA Submissions and Communicating with the FDA (INDs, NDAs, BLAs, ANDAs, PMAs, 510(k)s, IDEs, Post-Approval Supplements)" has been pre-approved by RAPS as eligible for...
Concerned sectors: Medical Informatics -
Online Conference Biomedical : Auditing Analytical Laboratories for FDA Compliance
Overview: Auditing analytical laboratories can be complex because of the preparation that is often required. All of the GMP rules do not apply to the laboratory; while there may be additional requi...
Online Conference Medical and Hospital Management : Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences
Overview: This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan....
Online Conference Biomedical : 3-Hour Virtual Seminar on DHF, DMR, DHR, TF , Design Dossiers - The Requirements
Overview: This webinar will examine the existing and proposed requiements for the U.S. FDA's DHF, 21 CFR 820.30 and now ISO 13485:2016 7.3 including its derivitive documents, the DMR and...
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