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Colloque Informatique médical : Medical Device Software: An Incremental Approach to Risk and Quality Management
Course "Medical Device Software: An Incremental Approach to Risk and Quality Management" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recert...
Secteurs concernés: Informatique médical -
Cycle de Formation Informatique médical : 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...
Secteurs concernés: Informatique médical -
Cycle de Formation Informatique médical : FDA Trends for CSV Compliance and Enforcement | Boston Seminar 2018
Course "FDA Trends for Computer System Validation (CSV) Compliance and Enforcement" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertifica...
Secteurs concernés: Informatique médical -
Conférences en ligne 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...
Secteurs concernés: Biomedical -Management médico-hospitalier -
Conférences en ligne Biomedical : 21 CFR Part 11 Compliance for Computer Systems Regulated by FDA
Overview: The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR ...
Secteurs concernés: Biomedical -Management médico-hospitalier -
Conférences en ligne Biomedical : Non-Conforming Material and Failure Investigation
Overview: Non-conforming material happens. And medical device companies must deal it. This 90-minute webinar will help you to make sense of confusing regulations and effectively deal with non-confo...
Secteurs concernés: Biomedical -Management médico-hospitalier -
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