Event Catalog

Avoid FDA 483s by properly configuring and validating GxP-compliant Excel spreadsheets — with live step-by-step setup of audit trails, security features, and data entry verification.

David Nettleton

Learn how to implement a risk-based audit trail review-by-exception strategy that reduces reviewer fatigue while strengthening detection of critical compliance, data integrity, and cybersecurity risks.

Carolyn Troiano

A 3-hour deep dive into 21 CFR Part 11 and data integrity for SaaS/PaaS cloud systems — covering audit trails, shared responsibility, change management, and FDA inspection readiness.

Carolyn Troiano

Avoid FDA 483s by properly configuring GxP-compliant Excel spreadsheets — step-by-step setup of audit trails, security features, Part 11 compliance, and minimal-documentation validation.

David Nettleton

Go beyond theory — understand how ALCOA+ appears in real records, how Part 11 applies to electronic systems, and how to design documentation that withstands audits.

Charles H. Paul

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

Carolyn Troiano

Learn what FDA warning letters reveal about software validation, data integrity, audit trails, Part 11, CSV, CSA, change control and inspection readiness.

Meredith Crabtree

Learn how to implement a risk-based audit trail review-by-exception strategy that reduces reviewer fatigue while strengthening detection of critical compliance, data integrity, and cybersecurity risks.

Carolyn Troiano