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Training Medical Informatics : A Risk Based Approach to IT Infrastructure & Cloud Qualification, Compliance & Control
Course "A Risk Based Approach To IT Infrastructure & Cloud Qualification, Compliance & Control" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant&#...
Concerned sectors: Medical Informatics -
Colloquium Medical Informatics : 21 CFR Part 11 compliance for software validation and SaaS/Cloud Seminar 2018
Course "21 CFR Part 11 compliance for software validation and SaaS/Cloud" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon ...
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 : 3 hour Virtual seminar on FDA's New Enforcement of 21 CFR Part 11
Overview: FDA continues to enforce Part 11 through its ongoing Part 11 inspection and enforcement program. Just in the last 3 years FDA issued more than 30 warning letters with Part 11 relat...
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