Complying with U.S. Food and Drug 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 pro on your side to make sure your system is robust.
Join computer system validation (CSV) pro Carolyn Troiano in this live webinar as she walks you through both the CSV and system development life cycle 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, security, and compliance. Don’t try and meet FDA’s GxP regs without help—CSVs are critical if you want to work with the agency.
Here is a taste of what you will uncover:
Who Should Attend
Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.
- Casper E. Uldriks
Carolyn Troiano has more than 35 years of experience in the tobacco, pharmaceutical, medical device and other FDA-regulated industries. She has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe, developing and executing compliance strategies and programs.