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Life Sciences and Pharmaceuticals: Advanced Risk and Quality Management
COURSE

Life Sciences and Pharmaceuticals: Advanced Risk and Quality Management

INR 59
★ 0.0 Rating
📂 Industry Enablement for IT

Description

Covers holistic risk management, quality by design (QbD), Six Sigma, Lean, and CAPA best practices, as well as IT support for continuous improvement.

Learning Objectives

Learners will apply leading risk analysis, QbD frameworks, continuous improvement, and IT for ongoing quality/risk monitoring.

Topics (8)

1
Enterprise Risk Register and Prioritization

Digital risk logging, scoring models, dashboards, compliance triggers.

2
Failure Mode and Effects Analysis (FMEA) in Pharma

FMEA, risk scoring, root-cause, mitigation tracking, periodic review.

3
Quality by Design (QbD) and Real-Time Release

QbD, control strategy, process analytics, PAT tools.

4
Continuous Improvement: Lean/Six Sigma in Pharma IT

DMAIC, digital gemba, value stream mapping, Kaizen analytics.

5
Automating CAPA and Compliance Analytics

Problem reporting, action tracking, aging, closure, visualization.

6
Audit Management and Digital Inspection Readiness

Digital checklists, findings, response tracking, inspection portals.

7
Supplier Quality and Third-Party Risk

Supplier assessment, issue/risk dashboards, quality agreements.

8
IT Support for Advanced Quality Programs

System integration, AI in audit/quality, predictive QA.