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 computer system validation (CSV) prò 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.
Carolyn Troiano has more than 35 years of experience in the tobàcco, pharmaceutical, medical device and other FDA-regulated industries. She has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobàcco companies in the US and Europe, developing and executing compliance strategies and programs. Read more
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