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
"I feel much more prepared to do my job. Thank you so much. Speaker provided Clear concise information, she was extremely knowledgeable.
"
Angelique Luzader
"The knowledge that the presenter shared. Her enthusiasm was awesome!"
Monica
"Learning the importance of REAC due to I am a new Property Manager this is very helpful. "
Steve
"The subject matter was very interesting and the instructor was well informed. Content of the webinar was Very Helpful!"
Lucious Cameron
"Elga was very engaging to listen and learn from. She gave good examples to follow."
Kari Annen
"The instructor's ability to explain different findings and her ability to relate to them. Her knowledge and experience are game-changer and will help us keep a high score. "