Digital Quality Metrics and AI/ML Analytics: Building a Continuous-Improvement Framework that Aligns with Regulatory Expectations
Learn how AI/ML and real-time digital quality metrics build a continuous-improvement framework aligned with FDA regulatory expectations, 21 CFR Part 11, and GAMP®5.
Instructor
Carolyn Troiano
FDA Compliance & Computer System Validation Consultant
What You'll Learn
About the event
About this event
The life science industries, including pharmaceutical, medical device, biotechnology, biological, and tobacco and tobacco-related products continue to embrace new technology to improve delivery of quality products in compliance with FDA. Artificial Intelligence (AI), Machine Learning (ML) and Large Language Models (LLMs), such as ChatGPT are beginning to find a presence at these companies.
As the pace of technological innovation becomes more intense, there is a critical need for computer system validation, 21 CFR Part 11 (Electronic Records and Electronic Signatures) compliance, and data integrity assurance to continue in environments where AI and ML are becoming more prevalent.
Using real-time digital quality signals for metrics will optimize efficiency, quality, and compliance. AI/ML can be used to detect trends, deviations, anomalies, and drift early in a process, enabling quicker action to mitigate potential risk. Dashboards built for AI/ML tools support data integrity in metrics pipelines and aggregation layers, and also support Part 11 compliance and risk-based decision-making.
The analytics can ultimately plug into the SDLC and GAMP®5 (Second Edition) control strategy. AI can hallucinate, and show bias and performance drift — AI solutions need human guardrails and expert oversight to make the right judgment calls for better outcomes and quality decisions.
We'll provide an overview of validation, including CSV and Computer Software Assurance (CSA), and the latest GAMP®5, 2nd Edition that aligns with CSA, walking you through the Software Validation and Maintenance approach that will bring clarity to what FDA is looking for in terms of compliance.
Code: FDB2847
Curriculum
Requirements
- Working in FDA-regulated industries (pharma, medical device, biotech, tobacco)
- Involvement in planning, executing, or managing computer system validation
- Applicable to IT analysts, QA/QC managers, regulatory affairs, clinical data, and compliance roles
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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