Audit Trail Review by Exception: Reducing Reviewer Burden Without Weakening Detection
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.
Instructor
Carolyn Troiano
FDA Compliance & Computer System Validation Consultant
What You'll Learn
About the event
About this event
In FDA and globally regulated environments, audit trail review has become one of the most resource-intensive and misunderstood compliance activities. Many organizations continue to apply manual, exhaustive review approaches that generate reviewer fatigue, slow batch release, and dilute focus on truly critical events.
This session explores how to implement a risk-based, "review by exception" strategy that reduces reviewer burden while strengthening the ability to detect meaningful compliance, data integrity, cybersecurity, and operational risks. Attendees will learn how modern approaches aligned with FDA expectations, data integrity guidance, and risk-based validation principles can improve efficiency without sacrificing control.
The discussion will also address the role of AI-enabled analytics, automation, prioritizing risk, and ensuring human critical thinking remains the final guardrail for decision-making.
WHY YOU SHOULD ATTEND
This webinar is intended for those involved in planning, execution, and support of computer system validation activities, working in the FDA-regulated industries, including pharmaceutical, medical device, biologics, tobacco and tobacco-related products. Functions that are applicable include research and development, manufacturing, Quality Control testing, distribution, clinical trial management, sample labeling, adverse events management, and post-marketing surveillance. Whether involved in software development, testing, implementation, validation, maintenance or use of AI-enabled solutions, you will find a wealth of knowledge to enhance your ability to use these technologies with maximum effectiveness. Those using these systems must understand their role as the human guardrail of AI, critically assessing the outcomes, making intelligent judgment calls, and ensuring better decisions.
Code: FDB3242
Curriculum
Requirements
- Working in FDA or globally regulated life sciences environments (pharma, biotech, medical device, tobacco)
- Applicable to IT, QA/QC, validation, regulatory affairs, lab, clinical, manufacturing, and compliance professionals
Who Should Attend
Information Technology Analysts and Developers, QC/QA Managers and Analysts, Analytical Chemists, Compliance and Audit Managers, Laboratory Managers, Automation Analysts and Managers, Manufacturing Specialists and Managers, Supply Chain Specialists and Managers, Regulatory Affairs Specialists, Clinical Data Analysts and Managers, Clinical Trial Sponsors, Computer System Validation Specialists, GMP Training Specialists, Business Stakeholders and Subject Matter Experts, Business System Testers, Consultants working in life sciences, Auditors engaged in internal inspection, and vendors and software development companies supporting the life science industries.
Areas Covered
Meet Your Instructor
Carolyn Troiano
FDA Compliance & Computer System Validation Consultant
Carolyn Troiano has more than 45 years of experience in computer system validation in the pharmaceutical, medical device, biotechnology, tobacco, and other FDA-regulated industries. She is currently an independent consultant, advising companies on FDA compliance, Computer System Validation (CSV), and large-scale IT system implementation projects. Carolyn participated in the FDA/Industry Partnership to develop 21 CFR Part 11, the FDA's Guidance for Electronic Records and Electronic Signatures. During her career she has provided training on CSV, 21 CFR Part 11, Data Integrity, and many other compliance topics of interest to the life science industries.
Event Details
Format
Recorded Webinar
Duration
1.5 hours
Certificate
Included
Access
Lifetime
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