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2011 - Efficient Computer System Validation - 10 Easy Steps - Webinar By GlobalCompliancePanel



VenueWilmington, USA - United States USA - United States

KeywordsHealth Care, Medical Device, Compliance Training


Topics/Call fo Papers

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 -, 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

Last modified: 2011-04-01 19:21:09