FDA Compliance

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  1. Webinar

    21 CFR Part 11, FDA's Guidance for Electronic Records and Electronic Signatures

    Carolyn Troiano

    23 Nov 2021, Tuesday   10:00 AM PDT   90 Mins   WEB00145

    This 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 Part 11. This includes development of a company philosophy and approach, and incorporating it into the overall computer system validation program and plans for individual systems that have this capability.

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