MP-A Seminars

9:30 am - 9:50 am

Decision Making for Process and Product Sustainability in an Uncertain World

Rational, transparent decision-making is vital for effective innovation management in the manufacturing process industries. Those prioritising projects and/or technological options on sustainability grounds early in the R&D cycle however face a twin challenge: holistic decisions must incorporate complex success criteria but there is invariably a substantial degree of uncertainty about the evaluation. We present both a practical framework for early-stage sustainability assessment amongst a set of alternatives and an improved method of multiple-criteria decision analysis, CURE (Computed Uncertainty Range Evaluations), illustrating through case study how they may be readily implemented to support a facilitated decision-making process in the pharmaceutical industry.


9:50 am - 10:10 am

Helium Crisis?

Presentation based on this published Blog:

Helium crisis revisited

Are we on the cusp of a helium crisis? There are many examples of scientists predicting that global helium reserves will be depleted in 20 to 35 years but we don’t believe this is credible. The Mineral Commodities Summaries 2023, produced by the US Geological Survey, part of the US Department of the Interior, reports that global reserves of helium total 39,850,700 million cubic metres. The Geological Survey has very detailed accounts of reserves and production, but it does not give consumption figures. If we assume consumption is equivalent to the production of 160,000 million cubic metres, then reserves for 249 years are calculated [4]. Based on 2019 data [1], supplies are adequate for an estimated 335 years,

The largest terrestrial helium reserves are in the US. In 2022, the US was responsible for 46.9% of global production4. About 75% of this helium is extracted from natural gas of the Panhandle-Hugoton field, which straddles Texas, Oklahoma and Kansas. This natural gas is helium-rich, with an average concentration of 0.586% [2]. Helium has been found in concentrations as high as 8% in some global sources of natural gas. In the US, the lowest practical helium concentration that can economically justify extraction is about 0.3% [3]. Qatar is the second-largest producer, with 37.5% of global production in 2022. The US and Qatar together accounted for 84.4% of world production in 2022, followed by Algeria (5.6%), Russia (3.1%) and Australia (2.5%) [4].

According to many sources, we are still being affected by a helium shortage that began in 2019 as a result of the prolonged closure of the world’s largest purification facility in the US and critical maintenance at another two of the world’s eighth-largest purification plants. This became more pronounced in 2021 and 2022. The price of helium saw an increase of 300% between 2000 and 2020.

1. LCGC blog, 11/4/22.
2. Brown, A (2019). Origin of Helium and Nitrogen in the Panhandle-Hugoton Field of Texas, Oklahoma and Kansas, US. AAPG Bull. 103 (2), 369–403. doi:10.1306/07111817343
3. National Academies of Sciences, Engineering and Medicine (2000). The Impact of Selling the Federal Helium Reserve. Washington, DC: The National Academies Press.
4. Mineral Commodities Summaries 2023, US Geological Survey, US Department of the Interior.


  • Frank Judge Consultant Chemist - Chromatography - Butterworth Laboratories Ltd
10:10 am - 10:30 am

Engineering a Sustainable World – The Chemical Engineering Challenge

The United Nations’ Sustainable Development Goal 3 is good health and well-being. Within that goal, key 2030 targets are to end preventable deaths in children under 5, end epidemics of common and neglected diseases and significantly improve mortality from non-communicable diseases. The pharmaceutical industry will play a major role in enabling that goal and chemical engineers, in turn, enable the industry to scale up production and run plants in a safe, efficient and – this is increasingly important – sustainable way.


“Engineering a Sustainable World – the chemical engineering challenge”, published by the Institution of Chemical Engineers this year, sets out how the profession will contribute to addressing the SDGs. Peter Iles-Smith, one of the advisors contributing to this document, will set out the challenge for the pharmaceuticals industry, how chemical engineering contribute to solving it, and what changes, innovations and skills we need to make it happen.


11:30 am - 12:30 pm

KEYNOTE: Emerging Technologies Transforming and Reshaping Sustainability in Pharmaceutical Manufacturing


2:00 pm - 3:00 pm

KEYNOTE: Risk Mitigation of API Supply, Shortages Analysis

There has rarely been a time in the industry where we have had so many forces of this magnitude influencing the trajectory of the operations strategy.  In the midst of firefighting, Operation leaders have found it difficult to take the time necessary to understand how all of these trends work together.  The environment is more complex than before because Operations leaders are facing new or stronger forces on top of normal issues.  These forces pushing industry to add more cost, complexity and risk – with compounding effects.  Each organization has a different level of exposure they will need to grapple with, however all players have one thing in common – the amount of mobilization needed to succeed in the face of these trends is enormous
and will need thoughtful prioritization the slides cover the network of forces impacting the pharmaceutical API supply, as well as looking on the historical data and root cause analysis of the past shortages, so that the next shortage can be predicted. The main findings are highlighted. The other part of slides represents possible risk mitigation activities for the companies to secure API supply. Is second source is always an option? Or will European manufacturer be more reliable than Chinese, if we don't track the whole node map of API supplier and Tier suppliers’ risks. The experience of Dechra with 9 internal manufacturing sites globally and about 50 CMO managing will be represented in the risk assessment and contingency plan setting up.


3:45 pm - 4:15 pm

Sustainability: A Way of Life in Our Industry?


4:15 pm - 4:45 pm

Driving Sustainability in a Clinical Research Organisation


9:15 am - 9:35 am

Becoming a QP – The VIVA is Just the Beginning


  • Damian Larrington Pharmaceutical Quality Professionals - Pharmaceutical Quality Professionals
9:35 am - 9:55 am

Navigating the Path to Success: Professional Development for Growth, Progression and Succession

In today's dynamic and competitive business landscape, professional development has become an essential cornerstone for individual and organisational success. This presentation, titled "Navigating the Path to Success: Professional Development for Growth, Progression, and Succession," delves into the critical strategies and practices required to ensure personal and organizational growth, progression, and smooth succession planning.


9:55 am - 10:15 am

Changing the Quality Culture of a Business

Changing the quality culture of a business

"The pessimist complains about the wind. The optimist expects it to change. The leader adjusts the sails."
Identifying the common areas businesses struggle to get engagement
• Input into quality events
• Reviewing and understanding SOPs
• Incorporating Quality into decision making
Finding solutions to improve engagement
• Showing how Quality can make their roles easier i.e. can aid them implementing a change by interdepartmental collaboration
• Effective training so the purpose of an SOP is understood – it is a document to help processes and are always a working progress
• Demonstrating the impact engaging with quality events can have on the processes, they can be part of the solutions to bring the company forward


10:45 am - 11:45 am

KEYNOTE: Artificial Intelligence in a G x P Environment and its Impact on YOU – How to Stay Relevant in the AI World

Martin was part of a collaboration who designed the first Qualified Person (QP) prototype to assist in product release decisions. Martin required 8 years of education and experience to become a QP, the ‘traditional way. In comparison, it required just 5 hours to ‘train’ the AIs neural networks everything they needed to know. Although the prototype is still under validation, it’s a sign of things to come, or is it? Martin’s session will be of interest to anyone wishing to stay relevant in a world dominated by AI by answering the most important questions of our time.

As AI becomes more capable, affordable, and available.

  • How will it continue to accelerate drug discovery and speed to market?
  • How could AI be used in decision making?
  • How could AI be used in risk mitigation by:
    • Identifying error patterns early on to allow prompt intervention.
    • Responding to adverse dug reactions, customer complaints faster and with greater accuracy and precision
  • Will LLMs (Large Language Models) be capable of writing your policies, validation protocols and SOPs?
  • How will AI improve preventive maintenance, right first time and other efficiencies?
  • At a personal level – how can you be sure AI is telling the truth, the whole truth and nothing but the truth?
  • Is this technology compatible with pharmaceutical regulations, specifications, and authorities’ expectations? How will we manage this transition?
  • AI and its unintended consequences – what are they and how do we prepare?

And finally, how do we prepare our people to work in collaboration with AI? What are the rules for us humans in the age of automation?



12:15 pm - 1:15 pm

KEYNOTE: Process Modelling Advancement in Drug Product Development

Digital manufacturing and process modelling approaches are gaining significance in drug product development. In this talk, an overview of process modelling approaches will be given and its application in a real industrial case study will be discussed. The application of process modelling tools to increase process understanding and process scale up to facilitate technology transfer and life cycle management is in increasing demand. Validation of process models using industrial real life data for roller compaction process will discussed in detail during this presentation.


2:15 pm - 2:35 pm

Safety Considerations in Manufacturing Pharmaceuticals


2:35 pm - 2:55 pm

Quality by Design for Projects and Processes


  • Richard Coe GDP Responsible Person - Protogen Consulting
2:55 pm - 3:15 pm

Manage Industrial Assets in Pharmaceutical Manufacturing


  • Zhiru Tang Platforms Engineering Manager, Biologics & Devices Manufacturing - GSK
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23-24 April 2024 | Coventry Building Society Arena
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