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FDA Inspections After QMSR: What Replaces QSIT 2.0 - The New Inspection Reality

This course enables organizations to convert informal AI use into controlled, clearly defined processes that can be consistently explained, verified, and justified during inspections, reducing exposure created by undocumented practices and inconsistent personnel responses. This Course is designed for professionals responsible for result assessment, investigation oversight, and quality decisions that must withstand regulatory review.

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US $190 per learner

30-Days Unlimited Streaming Access

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To Get 30-Day Access to ONLY this Course 

US $190 per learner
  • This course is Included in Subscription Pack
Subscription include access to entire Learning Library
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  • Instructor : Carolyn Troiano
  • Study time : 82 Minutes
  • Skill Level: Intermediate
  • Course ID: TF1411
  • Assessment & Certification Included
  • Ask the Expert

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About the 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

  • How inspections unfold and how AI-influenced processes are evaluated
  • Where AI use becomes visible during document review and personnel interviews
  • Trigger points that lead to deeper regulatory scrutiny
  • Defining controlled use and accountability within quality systems
  • Aligning procedures with actual execution of AI-supported activities
  • Preparing personnel for consistent, accurate inspection responses
  • Documentation practices that demonstrate traceability and verification
  • Common failure scenarios and internal assessment approaches

Who Must Attend

  • QA/QC Departments
  • Quality System Owners
  • CAPA and Investigation Leaders
  • Regulatory Affairs Departments
  • Compliance Professionals
  • Validation Departments

Quality training, expert insights, and answers that matter. Know your Expert

MEREDITH CRABTREE

Meredith Crabtree brings over 30 years of leadership in regulated industries including Pharma, Biologics, and Medical Devices. As the founder of MLKC Consulting, she’s known for her sharp regulatory acumen, hands-on approach to quality systems, and expertise in inspections, recalls, and compliance remediation. Her real-world insight makes her the ideal mentor for mastering aseptic processing and validation practices.

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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.

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