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Computer System Validation: Step-by-Step Course "Computer System Validation: Step-by-Step" has been pre-approved by RAPS as eligible for up to 1.25 credits towards a participant's RAC recertification upon full completion.

 

 

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Date & Time: Thursday, May 31, 2012

10:00 AM PDT | 01:00 PM EDT

Duration: 75 Minutes

Instructor: David Nettleton

Location: Online

Price : $245.00

(for one participant)

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.

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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.

Instructor Profile:

David Nettleton FDA Compliance Specialist,

David Nettleton, is an FDA Compliance Specialist for 21 CFR Part 11, HIPAA, and Computer System Validation. His latest book is "Risk Based Software Validation Ten easy Steps" that 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....more

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It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely benefit from this program. For more information, please contact the event coordinator. We look forward to seeing you at the webinar. Best regards, Event-coordinator GlobalCompliancePanel

About GlobalCompliancePanel GlobalCompliancePanel is an online knowledge fulfillment community portal & it has put together a new model for online compliance training by creating a single window of learning opportunities for compliance professionals & providing a forum for expert speakers/panelists to render their services through simplified online training delivery mechanisms. Our commitment is give compliance regulatory training, showcasing of best industry practices & quality enrichment training sessions in a most cost effective manner. Compliance professionals can benefit from a wide range of training sessions, giving a diverse choice of events & all sessions being either Live or recorded stream or in the form of audio CDs. GlobalCompliancePanel portal ensures a secure & cost effective online environment and also support your E-learning and development on/through our website. Keep track of all webinars arranged for your industry through notifications & event calendars being mailed to your inbox. GlobalCompliancePanel opens new doors of learning opportunities for professionals.


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Computer System Validation: Step-by-Step  

This webinar details all of the templates used to create validation documentation, usually saving two-thirds of the time and costs. The 10-s...

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