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Tue - Jun 21, 2011 @ 03:00 PM CDT Ended
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Efficient Computer System Validation - 10 Easy Steps - Webinar By GlobalCompliancePanel

(www.globalcompliancepanel.com)

Overview: This webinar details all of the templates used to create validation documentation, usually saving two-thirds of the time and costs.

The 10-step risk-based approach to COTS software validation minimized documentation and ensures efficient implementation of new and upgraded computer systems. This experience will prepare you to perform a validation project.

Areas Covered in the Session:

* Learn which documents the FDA expects to audit.
* How to use the risk-based validation approach to lower costs.
* How to link requirements, specifications, risk management, and testing.
* Document a computer system validation project using easy to understand fill-in-the-blank templates.
* Based on: "Risk-Based Software Validation – Ten Easy Steps" (Davis Horwood International and PDA - www.pda.org, 2006).
* Step-by-step instructions for performing and documenting a risk assessment, and how to use the results to reduce validation documentation.
* Reduce testing by writing test cases that trace to elements of risk management.

Who Will Benefit:

* IT
* QA
* QC
* Laboratory staff
* Managers
* GMP, GCP, GLP professionals

Price List:
Live : $245.00
Corporate live : $995.00
Recorded : $295.00

Tags

  • Code of Business Conduct, Governance Documents, Compliance, Compliance Training, Compliance Webinar, FDA, ISO, Clinical Trials, John E Lincoln risk management, Risk Assessment, management process, Ris

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