Program Overview
This program equips corporate professionals with the ability to define, monitor, and apply QMS (Quality Management System) metrics and ensure data integrity for informed and defensible decision-making. Led by an industry veteran with over 25 years of global quality and compliance expertise, the course blends conceptual foundations, regulatory insights, real-world case studies, and hands-on simulations. Participants will learn how to apply ALCOA+ principles, build meaningful dashboards, and interpret critical-to-quality (CTQ) metrics to drive compliance, mitigate risks, and support operational excellence.
Features
- Interpret and apply key QMS metrics aligned with regulatory and business requirements.
- Implement ALCOA+ principles to strengthen data integrity and trustworthiness.
- Utilize metrics dashboards for risk-based decision-making and performance improvement.
- Draw insights from regulatory case studies to prevent compliance failures.
Target audiences
- QA/QC Professionals
- Regulatory Affairs Teams
- Compliance Officers
- Operations and Manufacturing Managers
- R&D Leaders
Curriculum
- 4 Sections
- 19 Lessons
- 1 Day
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- QMS Metrics & Data Integrity Principles5
- 1.1Defining QMS metrics: compliance, operational, product quality, customer-centric indicators
- 1.2Critical-to-Quality (CTQ) metrics and regulatory expectations (ICH Q10, ISO 13485, FDA, EMA)
- 1.3Data integrity Essentials
- 1.4Leading Vs Lagging Indicators, KPI Vs KQI, CAPA Effectiveness Metrics
- 1.5OOS/OOT Metrics, Audit Readiness, Data Lifecycle
- Regulatory & Operational Landscape5
- 2.1Regulatory expectations on QMS metrics and integrity (US FDA, MHRA, EMA, WHO)
- 2.2Case of data integrity warning letters and regulatory citations
- 2.3Metrics misuse/misreporting → compliance risks
- 2.4Integrating QMS metrics into management reviews, risk management, and business KPIs
- 2.5Digitalization trends: eQMS, electronic batch records (EBR), audit trails, real-time dashboards
- Real-Life Case Studies – Good vs Bad Practices5
- 3.1Case 1: FDA 483 observation on incomplete audit trails
- 3.2Case 2: Successful integration of real-time deviation tracking metrics in pharma
- 3.3Case 3: Lessons from a device recall linked to poor CAPA effectiveness tracking
- 3.4Case 4: Industry example of leveraging quality metrics for predictive risk modeling
- 3.5Strategies that differentiate compliant organizations from lagging ones
- Interactive Simulations & Exercises4
Instructor
