Advanced Topics in Computer Validation An Interactive Webinar Series with Case Studies and Discussi

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Event Date/Time: Mar 15, 2011 End Date/Time: Mar 15, 2011
Registration Date: Mar 15, 2011
Early Registration Date: Mar 15, 2011
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A system by system approach to validation is inefficient and more expensive that having a strong, coherent corporate strategy for computer validation. Validation projects need to be proactively aligned with business strategies and the organization’s budget process. This webinar presents an experience-based practical approach to QMS policies, directives, metrics, and standard practices to assure compliance of computerized systems for GCP, GLP, GMP, and 21 CFR Part 11 regulations.

Webinar Format: 60 minute interactive tutorial plus 30 minute case study work followed by 30 minute instructor facilitated round table discussion by participants.

Participants will be able to do the following from this course:

Identify three key policies to be developed and the SOPs to support them
Describe a QMS process for active management support in the strategy for computer validation in their organization that gives documented evidence of management’s “due diligence”
Make a list of the essential SOPs needed for computer validation practices at the corporate level