Quality Metrics Training

Quality Metrics Training

Measure What Matters. Improve What Counts.

The FDA has shifted from routine biannual inspections to a risk-based inspection model under the Food and Drug Administration Safety and Innovation Act (FDASIA). Quality Metrics now play a vital role in demonstrating the strength of a pharmaceutical manufacturer’s quality system.
This course enables pharmaceutical companies to design, track, and interpret Quality Metrics that drive continuous improvement, support inspection readiness, and strengthen the internal quality culture. Companies exporting to the U.S. also benefit from reduced inspection frequency and risk-based inspection scheduling through the adoption of strong Quality Metrics programmes.

Target Audience

Quality Heads
Quality Group Leaders / Quality Managers
Quality Control Heads / QC Managers
Production Heads / Production Managers
Technical Managers / Engineering Managers

Course Outline

What is a “Metric”

Data vs Knowledge
Quality Objectives
Metrics and Measurement
KPIs

Plant Metrics

Predictive Metrics
Reactive Metrics
Risk Management
CAPA

Quality Metrics

Product versus Process
Process Parameters versus Quality Attributes
Data Collection Plans
Use of checklists and graphs

Quality Metrics and Culture

Quality Culture and Metrics
Metrics and changing the culture
Comparing metrics (Product to product, Site to site, Company to company)
Bad metrics

Duration

Two days

Key Takeaways

Build and interpret Quality Metrics based on FDA requirements
Strengthen quality culture using measurable performance indicators
Use predictive and reactive metrics to improve operational performance
Reduce inspection frequency and post-approval change workload through data-driven compliance
Move from reactive reporting to proactive continuous improvement

Categories

We understand the importance of approaching each work integrally and believe in the power of simple.

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