Webinar on “Ten-Step Process for COTS Computer System Validation - Reduce Time and Costs”

Dec. 17, 2012 - PRLog -- Description:

This webinar details all of the templates used to create validation documentation.

Why is it important to have a proper understanding of templates used to create validation documents? This is because it usually saves as much as two-thirds of the time and costs. This webinar will familiarize participants with the 10-step risk-based approach to COTS software validation, which minimizes documentation and ensures efficient implementation of new and upgraded computer systems. As a result,validation professionals can perform a validation project without hassles.

Areas Covered in the Session:

o   Learn which documents the FDA expects to audit

o   How to use the risk-based validation approach to lower costs

o   How to link requirements, specifications, risk management, and testing

o   Document a computer system validation project using easy to understand fill-in-the-blank templates

o   Based on: "Risk-Based Software Validation - Ten Easy Steps" (Davis Horwood International and PDA - www.pda.org, 2006)

o   Step-by-step instructions for performing and documenting a risk assessment, and how to use the results to reduce validation documentation

o   Reduce testing by writing test cases that trace to elements of risk management.

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When:January 23, 2013, 10:00 AM PDT | 01:00 PM EDT

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By whom:

Founder of Computer System Validation (CSV), David Nettleton is an FDA Compliance Specialist for 21 CFR Part 11, HIPAA and Computer System Validation. His latest book, Risk Based Software Validation –Ten easy Steps, relates to the development, purchase, installation, operation and maintenance of computerized systems used in regulated applications.

He specializes in performing gap analysis, remediation plans, SOP development, vendor audits, training, and project management. He has completed more than 185 mission critical software validation projects. These have included clinical trial, blood bank, medical devices, document control, corrective action, laboratory instruments, electronic data capture, laboratory information management systems and so on.

An accomplished author, David has written extensively on a range of Compliance issues. He is co-author of Commercial Off-the-Shelf (COTS) Software Validation for 21 CFR Part 11 Compliance (Davis Horwood International and PDA - www.pda.org), and Electronic Record Keeping; Achieving and Maintaining Compliance with 21 CFR Part 11 and 45 CFR Parts 160, 162, and 164 (Interpharm/CRC - www.crcpress.com).

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For whom:

The webinar will benefit

o   IT

o   QA

o   QC

o   Laboratory Staff

o   Managers

o   GMP, GCP, GLP professionals

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Duration:75 minutes

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To enroll for this webinar, contact

webinars@globalcompliancepanel.com

Phone: 800-447-9407