GMP Services 

Decision Science Training for Risk-Based Decision-Making in Life Sciences

Leverage the pioneering research of Valerie Mulholland PhD and transform your PQS decision making. 

Our on demand e-learning series, informed by regulatory expertise and real Quality Risk Management (QRM) will provide you with the expertise you need to succeed.

Introducing: The Decision Science Series

Designed to support Quality Risk Management (QRM) effectiveness – this is your shortcut to superior, defensible Risk-Based Decisions in Life Science Quality.

The Challenge

The blueprint for improved risk-based decision making (RBDM) exists, but it’s scattered across decades of academic research and hidden within the practices of high-risk industries. Connecting the dots is time-consuming and complex.

The Solution

The Decision Science Series for Life Science Quality is your curated guide to this blueprint. Designed and presented by Valerie Mulholland, this series connects the dots for you & aligns directly with ICH Q9(R1) Quality Risk Management guidance and EU GMP Annex 22 expectations for data and science based decision making.     
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The 3 Pillars of our Decision Science Series

We translate complex knowledge into a powerful, practical framework by integrating three essential domains:

Pioneering PhD Research

The Foundation: Leveraging Valerie Mulholland's groundbreaking decision science research to provide scientifically rigorous methodology. This work was used to inform the ICH(R1) revision process and is in the ICH training material.

Cross Industry Expertise

The Edge: Essential insights from leading decision scientists, risk & data scientists and organizational psychologists and applied to decision making in  the life science context.

PQS/QMS Application

The Goal: A practical framework for decision making and critical thinking, built for the Pharmaceutical Quality System (PQS) or Life Science QMS, giving you the ability to make, defensibly compliant decisions.

Who Needs This Series?

The Decision Science Series is essential for Quality Assurance professionals, Qualified Persons (QPs), Manufacturing leaders, Regulatory Affairs and Technical Operations specialists in regulated life science environments.

Your Journey: Build decision competence by learning how to recognize and manage subjectivity, complexity, uncertainty, and bias.
Your Outcome: Clear defensible regulator-ready decisions grounded in science, data, and human psychology.
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Dr Valerie Mulholland 

Providing Thought Leadership: Empowering Pharma and Biotech Professionals with Decision Science and Risk-Based Strategies for a Modern, Effective Quality System. Valerie's work, is referenced in the official ICHQ9(R1) training material 

I'm Valerie Mulholland, CEO of GMP Services, and I'll guide you through much of this series.
These courses bring together my PhD research on RBDM and a lifetime of experience in the life sciences.

My mission is to make Decision Science accessible and actionable and to help you build decisions you can defend with confidence. 
Mastering risk-based decision making is a critical, career-defining skill.
This knowledge is your strategic advantage, equipping you to navigate subjectivity, uncertainty and complexity with confidence.

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Dr Valerie Mulholland

Quality Risk Management 

In 2005, regulators published Quality Risk Management (QRM) guidelines (ICH Q9), giving the pharmaceutical sector a license to innovate responsibly, adopting new technologies and improved processes through evidence-led decisions.
Progress stalled when organisations defaulted to methods  better suited to other purposes, mistook scores for thinking, and ignored the science of decision-making.
ICH Q9(R1) (2023) re-centres QRM on decision science, emphasising decision quality, right-sized formality, bias control, and real-world effectiveness. 
Indeed risk science and decision making has become central to many of the ICH guidelines.
With AI accelerating change, there is now an urgent need to build decision-science capability so that QRM operates as a learning engine that reduces patient risk, improves flow and yield, and enables confident adoption of new technology.

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The service that GMP Services is known for!

GMP Services is Ireland's leading compliance intelligence partner for the Life Sciences industry. We go beyond standard training, delivering relevant, engaging, and interactive courses on quality and regulatory issues.
Our expertise spans the entire organization, equipping leadership teams and operations personnel alike with the knowledge to excel. Every program is custom-designed to ensure your specific learning goals are  met.

Working with a wide range of clients in the life sciences sector for over 25 years has given us a unique perspective on the industry. This perspective is a valuable asset to our Life Science clients. We provide expertise to clients in the following sectors. Pharmaceutical,  Bio-pharmaceutical, Blood & Tissue, Medical Devices, API, Excipients, Service Providers,  ATMP Manufacturing, Contract Operations, & Contract Laboratories.
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Design and Delivery of specialized GMP, Quality, and Regulatory training programs.

Our training is designed to maximise learning and engagement while keeping your operation and personnel up to date on the most recent compliance and regulatory requirements. All our training is bespoke and is designed for your operation and your training needs.

Auditing against international standards for medicinal products, ATMPs, blood products, ingredients, excipients, medical devices, suppliers and service providers.


Our trained audit team conducts independent and comprehensive audits of various regulatory standards, including risk management, and data integrity requirements. To ensure regulatory compliance, we train and mentor internal audit professionals, and employees who may host or interface in regulatory audits.


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