FDA Compliance

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  1. Webinar

    FDA vs Health Canada

    Rachelle D Souza

    28 Feb 2017, Tuesday   10:00 AM PDT   60 Mins   WEB01474

    This webinar will provide an understanding of the organizational hierarchy of FDA and Health Canada

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  2. Webinar

    Human Error Investigations, Root Cause Determination and CAPA Effectiveness

    Ginette Collazo

    27 Apr 2022, Wednesday   10:00 AM PDT   90 Mins   WEB01473

    We will discuss human error categories, near root causes and root causes for these events. We will discuss latest trends in human error issues in the industry.

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  3. Webinar

    FDA Modernization and Restructuring of the SDLC for Computer System Validation and Compliance

    Carolyn Troiano

    22 Apr 2022, Friday   10:00 AM PDT   90 Mins   WEB01471

    The attendee will learn about ways to modernize the System Development Life Cycle (SDLC) approach to Computer System Validation (CSV) by using automated testing tools.

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  4. Webinar

    How to write SOPs that Avoid Human Error

    Ginette Collazo

    24 May 2022, Tuesday   10:00 AM PDT   90 Mins   WEB01463

    This webinar training will discuss from content development to formats designed for human error reduction due to procedures.

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  5. Webinar

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

    Carolyn Troiano

    22 Mar 2022, Tuesday   10:00 AM PDT   90 Mins   WEB01461

    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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  6. Webinar

    Best Practices in Preparation for an FDA Computer System Audit

    Carolyn Troiano

    28 Jan 2022, Friday   10:00 AM PDT   90 Mins   WEB01437

    FDA requires that all computer systems used to produce, manage and report on “GxP” (GMP, GLC, GCP) related products be validated and maintained in accordance with specific rules.

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  7. 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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  8. Webinar

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

    Carolyn Troiano

    25 Feb 2022, Friday   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.

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