Carolyn Troiano has more than 40 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.
Carolyn participated in the FDA/Industry team that drafted 21 CFR Part 11, the FDA Guidance for Electronic Records and Electronic Signatures (ER/ES). She is active in seeking ways to streamline the validation process and do what she terms “Common Sense Validation,” removing tasks that do not add value, but carefully taking a risk-based approach and using critical thinking to drive plans and activities.
Speaker Testimonials
"Gwen was fantastic and the material was very informative."
Maria
"Gwen is ahead of the game in presenting what is needed in a timely way."
Angela
"Dr. B Lynn did a great job presenting the information."
Chris
"Loved the cartoons. Made it easy to understand."
Donald
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Sheri
"I learned the different levels of violations. Her experience is very evident. As long as I can retain the information, I will be on top of my game."