Prerequisites for joining the course is
i. Minimum 1 year of industrial experience
Week – 1 : Session – 1 (3 hours)
Basic understanding of Quality Evolution of Quality,
Quality Management Salient Quality vocabulary QMP & PDCA
Week – 1 : Session – 2 (3 hours)
Characteristic & roles of a successful quality leader
Risk management & Risk based thinking Processes,
Problem solving, TRIZ, TOC Juran’s trilogy,
PDSA, Kaizen, Six Sigma
Week – 2 : Session – 3 (3 hours)
Process Improvement,
Managing change
Quality & Management tools i.e.,
i. Affinity diagram,
ii. Interrelations digraph,
iii. Tree & matrix diagrams
Week – 2 : Session – 4 (3 hours)
Statistical Process Control
i. Process Variability
ii. Charts & techniques for statistical process control
iii. Using control charts for process control
iv. Process Capability
Week – 3 : Session – 5 (3 hours)
Voice of Customer
House of Quality
Quality by Design (QbD)
Methodology & Documentation, Risk
Week – 3 : Session – 6 (3 hours)
21 CFR & its recommendations
ICH guidelines
Data Integrity
Basics of Regulatory Affairs,
Types of product filings
Week – 4 : Session – 7 (3 hours)
Introduction to Project management
Basics of Project, Project life cycle,
Project manager Drivers of Project management,
Project Governance
Strategic Management process & Portfolio management system
Selection criteria
Week – 4 : Session – 8 (2 hours)
Assessment
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