Making Financial Sense of GMP (Good Manufacturing Practice): Change Management Training Course

Part of L&L: Making Financial Sense of GMP series:

Course overview

Robust change management is a critical element of a strong pharmaceutical quality system. ICH Q10 - Pharmaceutical Quality System, describes it as a vital part of the lifecycle approach to product quality. A change management system encourages and accelerates continuous improvement.

Elements of an effective Change Management system include:

• Active knowledge management
• Science-Based risk assessment
• Organisational agility
• Communication

In an environment of increasing globalisation, innovation and technological advances for life science firms and health authorities, change management presents significant challenges to all parties involved. What are the financial advantages of managing change? Should change be managed for compliance purposes only? What are financial consequences of ineffective change management?

This course is part of our GxP training (Good x Practice) course collection, which features a variety of topic areas to ensure you comply with the most recent quality guidelines. For more information on the latest EU GMP regulations, see our GMP training course covering the Annex 1.

Benefits of attending

Attending this session will help deepen your knowledge and support your understanding on how the change management benefits an organisation's financial performance.

The benefits of attending this session include:

• Learn about the impact of change management on the gross profit, operational costs and net profit
• Explore how change management can support efforts to reduce costs and improve profits
• Discuss change management elements that contribute to cost reduction
• Understand how financial decisions don't have to compromise change management process
• Consider what would happen if change management system was not a regulatory expectation

Who should attend?

This session is designed for senior life science professionals involved with change management either directly or indirectly.

The stakeholders are typically from executive and management roles responsible for and involved in decision making and striving to balance financial goals with compliance and quality requirements.

Other interested stakeholders not directly involved with compliance or quality include:

• Chief Operating Officers
• Chief Financial Officers
• Finance and costing analysts

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