The U.S. Food and Drug Administration (FDA) has high standards when it comes to computer system compliance and validation. You must design a process to consistently conform to requirements, and then run studies showing that the process works. And passing the validation process is no small task: You need standard operating procedures, detailed specifications, test plans, and more. Sound complicated? You bet it is.
Untangle your compliance confusion with Carolyn Troiano, who has more than 35 years of experience in the computer validation field. In this detailed audio conference, she’ll help you understand computer system validation (CSV) and how to apply the system development life cycle (SDLC) methodology when validating computer systems subject to FDA regulations.
After attending this audio event, you will be able to develop an appropriate validation strategy—as well as prove that your system does what it claims it can. You will also be able to maintain your system as it passes through its entire life cycle, from conception to retirement. Troiano will also discuss phases within the SDLC and how they form the basis for any CSV project. Most importantly, you’ll be up-do-date on FDA system requirements and SDLC methods.
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.
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.