Balancing Costs and Compliance: The Financial Side of GMP (Good Manufacturing Practice) Training Course

Course overview

Are you aware of how the GMP requirements impact the financials of an organisation?

How can you provide financial justification for a system or process which helps meet compliance?

Does being compliant save or cost a company money?
 
Good Manufacturing Practice (GMP) in the pharmaceutical industry is often seen as being stringent and heavily regulated. Company finance plays a role in being compliant. But what if we turn this around? How does compliance play a role in a company’s financial health?

Participants will learn about how being compliant impacts the three key financial statements – balance sheet, income statement and statement of cashflows. They will also learn how compliance can be used to improve financial health.

Pharmaceutical regulations and guidelines such as International Council for Harmonisation (ICH) and Pharmaceutical Inspection Co-operation Scheme (PIC/S) form a critical pathway for pharmaceutical companies. These are stringent requirements with one key goal – patient safety.

As regulations and guidelines are introduced, organisations work hard to stay compliant. Change is the only constant (as the saying goes), with balancing costs and compliance becoming a challenge.

In days of fast technological advances, are we choosing new shiny solutions and compromising efficiency? How do you know if a new machine, equipment or software solution will be both compliant and cost effective compared to the current state?

Leadership team members across the organisation work with regulations and guidelines daily, however it is rare for them to know how their decisions impact the financial position of a business. 

In this course, we explore how the elements of GMP impact the financials of an organisation. We also consider whether GMP requirements hold back innovation and increase costs, or do they unlock potential and support financial health of a business?

Some key elements we consider include:

• Pharmaceutical Quality System (PQS)
• Quality Risk Management (QRM)
• Validation Master Plan (VMP)
• Change management
• Personnel
• Documentation
• Quality control
• Quality assurance
• Audits
• Supplier Management

This course introduces you to tools and techniques you can use to prepare, produce or participate in activities involving compliance whilst balancing costs.

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.

Benefits of attending

Attending this session will help deepen your knowledge and support your understanding on how the GMP requirements benefit an organisation's financial performance.

The benefits of attending this session include:

• Learn about the impact of requirements on the balance sheet, income statement and statement of cashflows
• Explore how requirements can support efforts to reduce costs and improve profits
• Discuss elements of GMP requirements that contribute to financial efficiencies
• Understand how financial decisions don't have to compromise GMP requirements
• Consider what would happen if GMP requirements were not a regulatory expectation

Who should attend?

This session is designed for senior life science professionals involved with GMP requirements 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 (COOs)
• Chief Financial Officers (CFOs)
• Finance and costing analysts

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