Carolyn Troiano

With more than 45 years of IT/Compliance experience, I’m proud to join RiskCortex as Compliance & Quality Authority Lead. I’ll be convening more roundtables and driving the Expert-in-the-Loop (EIL) training program, the latter in partnership with Biopharma Institute.

Specialties:
o Upskill to the Expert-in-the-Loop (EIL) role to remain marketable in the era of AI
o FDA Compliance for Regulated Data & Computer Systems
o Computer System Validation/CSA, Data Integrity, Part 11 Compliance
o Data Privacy, Governance & Compliance (HIPAA, PHI, GDPRs)
o Strategic Planning, Business Process Mapping & Reengineering
o Project Management
o Organizational Change Management
o IT Security & Risk Management
o Cost-Benefit Analysis & ROI
o Training
o Coaching & Mentoring
o Sales & Marketing

My experience includes 45+ years in IT/ Business & Compliance leadership and management roles at a variety of Fortune 100 companies, across multiple FDA-regulated industries.

My successes include convening the first RiskCortex Regulatory Insights Roundtable, and I will continue in this role as we roll a new one out each quarter.

I also developed the Expert-in-the-Loop (EIL) certification training program that will be delivered live on the Biopharma Institute website. A 3-course program will provide the attendee with a Professional EIL Certificate, providing them the ability to upskill & remain marketable in the era of AI. A Master Certification series of 8 courses will also be delivered through 2026.