Data Governance and Computer System Validation (CSV) Compliance
Presented By: Carolyn Troiano
Live Webinar | Date: Tuesday, June 19, 2018 | Time: 1 pm ET | Duration: 90 minutes
Ensure FDA Compliance with Good Data Governance
Complying with U.S. Food and Drùg Administration (FDA) rules for GxP systems is neither easy nor cheap, but there are strategies and proven best practices than can smooth the process and help ensure that your data are governed with integrity and costs are minimized. The only hitch is you need a prò on your side to make sure your system is robust.
Join ‘Data Governance and Computer System Validation (CSV) Compliance,’ by Carolyn Troiano in this live webinar as she walks you through both the CSV and system development life cyclè methodologies. You need solid maintenance for your data governance systems, and Troiano is one of the best in the business at showing you the best ways to attain the level of compliance you need.
After attending this audio event you will know about good variable practices (GxP), good manufacturing practices, good laboratory practice, and good clinical practices, plus data archival standards aimed at ensuring integrity, securìty, and compliance. Don’t try and meet FDA’s GxP regs without help—CSVs are critical if you want to work with the agèncy.
Here is a taste of what you will uncover:
Computer system validation (CSV) and system development life cyclè methodology
Good “variable” practices (GxP), including good manufacturing practices, good lab practices, and good clinical practices
Data governance models and practices
Validation planning which takes into account the system risk assessment process and GAMP 5 system categorization
Data archival and governance to ensure securìty, integrity, and compliance
Good documentation practices
Exclusive Q&A session following the live event to get advice unique to your situation.
Please use “PM20” at check-out to get $20 off on registration.
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