Making Financial Sense of GMP (Good Manufacturing Practice): Validation Master Plan (VMP) Training Course

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

Course overview

Validation Master Plans (VMP) govern validation activities for an entire organisation. The VMP serves as the validation roadmap, setting the course, justifying the strategy, outlining the preliminary test and acceptance criteria, and documenting the necessary programs that ensure a continuing state of validation.

The VMP includes the following elements as expected by the regulatory agencies:

• Plan - documenting intent and pathway
• Qualification - confirming design and intent
• Process Validation - assures process consistency
• Reports - Summary of test results and acceptance criteria
• Compliance programs - Ensuring continuous state of validation

The VMP has cost implications from designing and executing to reporting and maintaining. Are these costs justified? What would happen if VMP was not part of regulatory expectations? Would organisations be motivated enough to implement VMP without regulatory expectations?

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 Validation Master Plan (VMP) benefits an organisation's financial performance.

The benefits of attending this session include:

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

Who should attend?

This session is designed for senior life science professionals involved with Validation Master Plan (VMP) 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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