Audit Trail Review by Exception: Reducing Reviewer Burden Without Weakening Detection
A practical session on using risk-based exception criteria, automation, and human review to manage audit trail workload across regulated systems.
GROUP SAVINGS: Get your team to attend for just $390.
Individual registrations available too.
It is crucial to separate signal from noise as reviewer fatigue is diluting critical event detection.
Audit trail review now requires choices about review depth, exception thresholds, automation, and evidence that can support regulated operational demands.
The session structures risk ranking, event categorization, AI-supported analytics, reviewer workflows, and inspection response into a practical model for audit trails.
The program moves from regulatory expectations and audit trail purpose into exception design, high-risk event patterns, automation opportunities, AI-assisted analytics, CSA alignment, inspection readiness, and a practical roadmap for sustaining the approach across regulated systems.
Setting exception criteria to know which audit trail events truly deserve review.
- FDA and global expectations for audit trail review
- Critical versus non-critical events and signal-to-noise judgment
- Exception criteria, risk ranking, and event categorization methods
- High-risk red flags including access, metadata, deletion, and timing anomalies
- Workflow changes that reduce low-value manual review
- AI-supported pattern detection, limits, explainability, and human review
- CSA-aligned evidence, SOPs, training, and inspection explanation
- Roadmap for moving from current-state review to sustained exception review
Designed for professionals responsible for audit trails, data integrity, validation, quality systems, regulated operations, or inspection response.
Carolyn Troiano
Carolyn Troiano brings more than 45 years of experience in computer system validation, FDA compliance, Part 11, data integrity, and regulated IT implementation. Her work across pharmaceutical, medical device, biotechnology, and other FDA-regulated environments directly aligns with audit trail controls, risk-based validation, and practical reviewer accountability.
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Customized training is also available through TalkFDA Elite Training Labs.
This topic can also be delivered as a customized session for organizations seeking structured, implementation-focused training aligned with their internal processes and quality systems.
TalkFDA Elite Training Labs