Event Catalog

Master risk-based Excel spreadsheet validation for FDA-regulated environments — covering GAMP 5, SDLC, 21 CFR Part 11, data integrity, and inspection readiness.

Carolyn Troiano

Apply project management best practices to FDA-regulated computer system implementations — covering SDLC, CSV, GAMP V, roles, documentation, and maintaining systems in a validated state.

Carolyn Troiano

Apply SDLC, GAMP 5, and risk-based validation to Excel spreadsheets used in FDA-regulated activities — covering Part 11, data integrity, and inspection preparation.

Carolyn Troiano

Translate FDA cybersecurity expectations into inspection-ready GxP actions — covering SDLC touchpoints, cloud/SaaS responsibilities, access control, and audit trail requirements.

Carolyn Troiano