Biography:

Carolyn Troiano has more than 40 years of experience in the pharmaceutical, medical device, tobacco, 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.

Carolyn’s expertise includes traditional Computer System Validation (CSV), Computer Software Assurance (CSA), the System Development Life Cycle (SDLC) Methodology (waterfall and agile), 21 CFR Part 11, FDA’s Guidance for Electronic Records and Electronic Signatures, Data Integrity, and Data Privacy. Her experience spans multiple types of system platforms, software types, and automation tools. She has implemented and validated very large-scale and complex enterprise-wide applications in all GxP areas of operation.

Carolyn provides webinar and seminar training, as well as consulting with life science industry clients.