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Experts Talk: Tool Validation per FDA Title 21 CFR Part 11

Webinar Date Time Duration
31 Jan 2019 4:00 PM (CET)
/ 10:00 AM (ET) / 7:00 AM (PT)
~30 minutes

experts-talk-tool-validation-per-fda-title-21-cfr-part-11What you can learn:

Join Intland Software's partner expert Kálmán Keresztesi (Controsys Ltd.) as he proposes a convenient, preconfigured solution to the Title 21 CFR Part 11 tool validation challenges related to codeBeamer ALM in regulated industries. Intland’s Title 21 CFR Part 11 Validation Template helps execute a qualification of the electronic records functionalities of our ALM platform. Using the template, you can validate codeBeamer's use in a fully electronic way fulfilling the requirements of Title 21 CFR Part 11 (FDA). In Kálmán's presentation and demo, you will learn about defining a validation strategy, and executing the entire validation process from defining organizational requirements to the release of a qualification report.

The webinar's agenda:

  1. Tool validation in regulated industries
  2. Title 21 CFR Part 11 requirements
  3. Risk-based System Overview
  4. Validation strategy: roadmap, procedure, roles and responsibilities
  5. The qualification report

Our webinar is intended for:

Business Analysts, Developers of products subject to Title 21 CFR Part 11