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Risk-Based Approach to Validating IT Infrastructure Used for FDA-Regulated Systems

Risk-Based Approach to Validating IT Infrastructure Used for FDA-Regulated Systems

Overview: For over three decades, the FDA has regulated computer system validation (CSV) acro..

Date : 25th March 2024

Time : This Event is Over and the Recorded Content is Available

Duration : 90 Mins

Risk-based Design Control - The New Paradigm for Medical Device Design

Risk-based Design Control - The New Paradigm for Medical Device Design

Overview: Risk management overarches projects associated with a particular product family, giv..

Date : 17th February 2022

Time : This Event is Over and the Recorded Copy is Available

Duration : 1 Hour 10 Mins

Functional and System Requirements for Systems Regulated by FDA in 2024

Functional and System Requirements for Systems Regulated by FDA in 2024

Overview: The validation of computer systems (CSV) under FDA regulations has shaped the way e..

Date : 25th November 2024

Time : 1:00 PM Eastern Time / 10:00 AM Pacific Time

Duration : 90 Mins

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