FDA Compliance

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  1. Webinar

    Data Integrity Compliance for Computer Systems Regulated by FDA

    Carolyn Troiano

    18 Oct 2021, Monday   10:00 AM PDT   90 Mins   WEB00163

    The Webinar will focus on the importance of ensuring that the validation of an FDA-regulated computer system will meet compliance guidelines.

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  2. Webinar

    Risk-Based Approach to CSV, 21 CFR Part 11 and FDA Compliance

    Carolyn Troiano

    24 Sep 2021, Friday   10:00 AM PDT   90 Mins   WEB00158

    This webinar will help you understand in detail Computer System Validation (CSV) and how to apply the System Development Life Cycle (SDLC).

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  3. 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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