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6-Hour Virtual Seminar on IT Systems Validation for FDA Regulated Industrie


This webinar will focus on how to properly validate FDA regulated IT systems in order to ensure that security and data integrity objectives are met and FDA enforced compliance is met. We will discuss IT Systems Validation approach based on FDA requirements.

We will walk through the entire System Development Life Cycle (SDLC) approach to validation of FDA-regulated computer systems, and will also discuss 21 CFR Part 11, European equivalent Annex 11, GAMP 5 which deal with controlling risk and managing computer systems over their life cycle including validation. We will discuss what is needed to prepare for an FDA inspection of computer systems and data.

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