Event Catalog

Master closed-loop CAPA with repeatable failure investigation and root cause analysis tools that satisfy FDA audit expectations in GMP environments.

John E. Lincoln

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

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

A 3-hour CSA playbook for SaaS and PaaS validation — learn to evaluate vendor evidence, interpret SOC reports, separate responsibility, and build FDA-defensible documentation.

Carolyn Troiano

A 3-hour course on validating CI/CD pipelines and automated workflows under CSA — challenge-based testing, automated evidence, and maintaining audit readiness in rapid-release environments.

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

Turn FDA labeling and UDI requirements into a controlled, inspection-ready system — cover 21 CFR 801, DMR linkage, misbranding risk, IFUs, and GUDID compliance.

José Mora

Navigate human error, documentation pitfalls, and GLP requirements — learn how accurate record-keeping supports data integrity, research reproducibility, and regulatory compliance.

Charles H. Paul

A step-by-step guide to investigating sterility test failures — covering FDA regulations, root cause tools, lot impact assessment, and audit-ready documentation.

Danielle DeLucy

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

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

Build GCP audit and inspection readiness — cover QMS, SOPs, documentation, internal audits, and personnel training to ensure compliant clinical trial execution.

Charles H. Paul