Making Financial Sense of GMP (Good Manufacturing Practice): Pharmaceutical Quality System (PQS) Training Course

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

Course overview

Pharmaceutical Quality System (PQS) is outlined in ICH Q10 guideline. The PQS is referred to as ICH Q10 Model and is based on International Standards Organisation (ISO) quality concepts, includes applicable Good Manufacturing Practice (GMP) regulations and complements ICH Q8 'Pharmaceutical Development' and ICH Q9 'Quality Risk Management'. 

The implementation of ICH Q10 model aims to achieve three main objectives and complements or enhances regional GMP requirements:

• Achieve product realisation
• Establish and maintain a state of control
• Facilitate continual improvement

There is intrinsic financial impact on each of these objectives and understanding it supports not only improving quality efforts, but aligns with financial and budgetary goals.

ICH Q10 is a model and regulatory expectation. What would happen if the regulatory expectation was removed?

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 objectives of ICH Q10 model benefits an organisation's financial performance.

The benefits of attending this session include:

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

Who should attend?

This session is designed for senior life science professionals involved with Pharmaceutical Quality System (PQS) 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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