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Digital Quality Metrics and AI/ML Analytics

Building a Continuous-Improvement Framework that Aligns with Regulatory Expectations

Course is now LIVE. Click below to join the session.

This course equips teams to use AI/ML-enabled quality metrics as a controlled decision tool, strengthening early risk detection, data review, and compliance oversight while keeping human judgment central to quality outcomes. This Course is designed for professionals responsible for validation, data integrity, quality metrics, or oversight of AI-enabled systems in regulated operations.

  • 18 June 2026
  • Eastern Time (US/Canada): 11.00 AM
  • GMT: 3.00 PM
  • 90 Minutes
  • FDB2847
  • Carolyn Troiano
  • Live Session + Post-live Continued Learning
  • Live Q&A Included
  • Presentation Handout & Templates
  • Assessment & Certification Included

REGISTRATION OPTIONS

Live session Plus Complimentary 30 Days Streaming access

$190  |  One participant (viewer)

$290  |  Team of 2-5 participants

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REGISTER FOR THE COURSE

US $290 per learner

30-Days Unlimited Streaming Access

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REGISTER FOR THE COURSE

To Get 30-Day Access to ONLY this Course 

US $290 per learner
  • This course is Included in Subscription Pack
Subscription include access to entire Learning Library
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  • Faculty
    Carolyn Troiano
  • Study time
    90 Minutes
  • Course ID
    TF2847
  • Skill Level
    Intermediate
  • Assessment
    & Certification Included
  • Ask the Expert
    Included

 

Why take this course?

Digital quality metrics are becoming more important as life sciences companies adopt cloud services, SaaS platforms, AI, ML, and LLM-enabled tools across development, manufacturing, testing, and support activities. These technologies can improve speed and visibility, but they also introduce validation, Part 11, and data integrity concerns that cannot be handled through general IT oversight alone. When metrics pipelines, dashboards, and analytics influence quality decisions, companies need clear control over how data is generated, reviewed, and used.

This program focuses on building digital quality metrics that support continuous improvement while remaining aligned with FDA-regulated expectations. It addresses how risk-based metric selection, AI/ML analytics, and dashboard design connect to SDLC activities, GAMP®5 (Second Edition), CSV, and CSA. It also examines supplier-provided analytics, data integrity in aggregation layers, and the practical limits of AI, including hallucination, bias, and performance drift, where human judgment remains essential to sound quality and compliance decisions.

  • Build metrics that support earlier quality decisions:

    This course helps teams move from delayed reporting to digital quality signals that can identify trends, deviations, anomalies, and drift sooner. That improves how risk is recognized across GxP systems and supports quicker, better-informed action before issues expand into larger quality or compliance concerns.

  • Use AI/ML analytics without losing compliance control:

    AI and ML can increase efficiency, but they also introduce risks tied to unreliable data, hallucination, bias, and shifting performance. This course strengthens how teams apply analytics within validated environments, maintain data integrity, and use human review as the guardrail for quality, compliance, and better judgment.


Key Areas Covered

  • Moving from lagging indicators to real-time digital quality signals
  • Selecting quality metrics for GxP systems using risk-based quality principles
  • Using AI/ML analytics to detect trends, deviations, anomalies, and drift earlier
  • Building dashboards that support data integrity, electronic records, and risk-based decisions
  • Connecting analytics to SDLC activities and GAMP®5 (Second Edition) control strategy
  • Verifying supplier-provided analytics and understanding what FDA expects companies to assess
  • Managing hallucination, bias, and performance drift in AI-enabled quality solutions
  • Presenting digital quality metrics during regulatory inspections and audits

Who Must Attend

  • Quality Departments
  • Information Technology Departments
  • Manufacturing & Automation
  • Regulatory Affairs Departments
  • Clinical Trial Professionals
  • Laboratory Professionals
  • Computer System Validation Professionals
COURSE DIRECTOR

Carolyn Troiano

Carolyn Troiano has more than 45 years of experience in computer system validation across FDA-regulated industries and advises companies on FDA compliance, CSV, and large-scale IT implementations. She also participated in the FDA/Industry Partnership that developed 21 CFR Part 11, bringing directly relevant experience in electronic records, data integrity, and validated digital systems.

If you would like to request a Proforma invoice to sign up for this course. please click here

Ready to Strengthen Your Team? Let’s Build Your Training Plan.

Whether you’re looking for a single onsite workshop or a multi-team training series, we’ll help you design a program that fits your goals, timelines, and operational reality.

Your team deserves the clarity.
Your organization deserves the confidence.

Upcoming Courses

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Testimonials

This is an upcoming session. Feedback below reflects experiences from similar programs delivered by our expert faculty.

“Session was easy to follow even for non-core team members. That helped.”
- Production Officer
“Good balance. Not too basic, not too deep. Worked well for mixed team.”
- Manager, Regulatory Affairs
“Team found it useful. Especially for aligning understanding across functions.”
- Director, Operations

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