Acceptance Criteria for AI Validation: Determining What "Reliable" Actually Means in GxP Systems
Learn how to define meaningful, risk-based acceptance criteria for AI systems in GxP environments — covering reliability thresholds, hallucination controls, human guardrails, and CSA-aligned validation strategies.
Instructor
Carolyn Troiano
FDA Compliance & Computer System Validation Consultant
What You'll Learn
About the event
About this event
Artificial Intelligence is rapidly being embedded into regulated GxP operations — from quality systems and manufacturing support to clinical, laboratory, and regulatory processes. But one question continues to challenge industry and regulators alike: What does "reliable" actually mean for AI in a regulated environment?
Traditional validation approaches were designed for deterministic systems that consistently produce the same output. AI introduces probabilistic behavior, evolving models, hallucinations, bias, performance drift, and opaque decision-making that require a fundamentally different way of defining acceptance criteria.
This session explores how life sciences organizations can establish meaningful, risk-based acceptance criteria for AI-enabled systems while remaining compliant with FDA, EMA, MHRA, GAMP®, and data integrity expectations. Attendees will learn how to move beyond checkbox validation and instead define measurable standards for trust, reliability, oversight, explainability, and human review within AI-driven GxP processes.
The discussion emphasizes the role of risk management and the critical human guardrail for AI-enabled decision making.
WHY YOU SHOULD ATTEND
Attendees will gain practical insight into one of the most urgent and misunderstood challenges in regulated AI adoption: How do you prove an AI system is fit for intended use when outputs may vary?
Participants will learn how to define defensible AI acceptance criteria aligned to patient safety, product quality, and data integrity; understand the difference between validating deterministic systems versus AI-enabled systems; apply risk-based thinking to AI oversight and validation activities; identify where human review is essential; reduce regulatory exposure associated with unchecked AI output; recognize warning signs of hallucinations, bias, drift, and unreliable AI behavior; build greater trust in AI-assisted GxP processes without creating excessive documentation burden; and prepare for increasing regulatory scrutiny surrounding AI usage in life sciences.
This session is especially valuable for organizations actively evaluating or implementing AI tools in regulated environments.
Code: FDB3243
Curriculum
Requirements
- Working in FDA or globally regulated life sciences environments (pharma, biotech, medical device)
- Involvement in computer system validation, CSV/CSA, quality systems, or digital transformation
- Applicable to QA, regulatory affairs, IT, data integrity, and compliance professionals
Who Should Attend
This session is designed for leaders and practitioners involved in regulated computerized systems, digital transformation, AI governance, and quality oversight. Essential for: Quality Assurance and Quality Systems professionals, Computer System Validation (CSV) and Computer Software Assurance (CSA) teams, IT and Digital Transformation leaders, Regulatory Affairs professionals, Manufacturing and Operations leadership, Laboratory Informatics and LIMS administrators, Clinical Systems and Data Management professionals, Data Integrity specialists, Cybersecurity and AI Governance teams, Compliance officers and auditors, Vendors and consultants supporting GxP systems, and Executive leadership evaluating AI adoption in regulated operations.
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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