23 April 2024 Seminars

9:30 am - 9:50 am

AI for the Real World

Having worked within the Pharmaceutical field for over a quarter of a century AI is by far the biggest step change that I have seen in terms of a single technology’s ability to improve the Quality of a process / product and generate insights from data.

Appraiseye, a partner company of Central Pharma Contract Packing has developed a suite of templates that enables AI’s rapid deployment within a host of operational, production, research and clinical environments to improve Quality and Efficiency in a way never seen before. Appraiseye’s application of AI removes the fiction from science fiction and provides organisations a true competitive advantage.

Speaker

  • Ian Robinson Group Business Development Director - Central Pharma
9:30 am - 9:50 am

Challenges of Remediating Global Supply of Critical Medicines and the Need for Senior Leadership Support

The presentation will cover the remediation of a global supply chain and its QMS to restart supply of critical and life saving medicines and the need for senior leadership support to achieve the safe flow of medicine after unfavourable inspections and failures of the local and global quality systems.
This will include overviews of remediating qms systems such as APQRs, deviations, batch back logs, versatility in training new staff and QPS, support and leadership, interactions with competent authorities and how some of the war stories were resolved and could be improved if faced again.

Speakers

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.

Speaker

9:30 am - 10:00 am

Environmental Sustainability in the Pharmaceutical and Health Care Supply Chain

Highlighting how Environmental Sustainability is considered in the Pharmaceutical and Health Care Supply Chain whilst maintaining a high standard of service, without compromising compliance. Will also discuss how the transport sector, and more specifically the Pharmaceutical and Healthcare transport sector, must be practical in their approach to Environmental Sustainability as well as also the consideration of the financial implications. This will also highlight that “Going Green” isn’t JUST about which type of fuel you may be using, but also the collaborative efforts that can, and are, undertaken by all the links in the Supply Chain.

 

Speaker

9:30 am - 10:00 am

Preparing for the Future – Learning From The Past to Foresee The Future

The chemical and pharmaceuticals industry is one of the United Kingdom’s largest industries and the nation’s second largest export commodity.

Many chemical and pharmaceutical supply chain stakeholders are taking responsibility for finding solutions and driving initiatives that help address, improve, and resolve industry challenges and the CBA continues to lead and facilitate collaboration, to use the challenges of recent years as catalysts for positive change, and to build and maintain momentum to ensure a sustainable future.

 

CBA’s new People & Skills Hub (P&SH) is addressing the need for a talented and well-motivated workforce that possesses a ‘can do’ attitude and the relevant skills, knowledge, and experience. We have introduced Generation STEAM which fully recognises the importance of STEM but also

recognises the ever-increasing need for creativity in today world, opening our industry to a wider

workforce in order to ensure people at all stages of their careers are empowered to build bright futures in the industry, attracting a wide range of talent and regardless of their background.

 

The chemical and pharmaceutical industry has a key and leading role to play in decarbonisation, which means that understanding carbon and other greenhouse gases and their role in climate change has become increasingly vital for all sector stakeholders. CBA’s Sustainability Hub is helping members understand their commitments now and how they can make a difference going forward.

 

Although the past few years have been challenging, the industry has been largely resilient and continues to adjust and adapt. Looking forward, the only thing that is certain, is that the future will involve more change and uncertainty.

 

In this presentation I will discuss how lessons learnt from the past can help to prepare for the future, for both the expected and unexpected challenges ahead.

Speaker

  • Karen Harvey Membership Manager - Chemical Business Association
9:30 am - 9:50 am

Validation – Three Batches is Enough (NOT)!

Effective validation requires a proper understanding of the behaviour of the process, in particular the variation that can occur within the process and how this impacts the process performance – whether the process is capable of being validated or not.

The presentation will discuss the types of variation that can occur within a process, how to manage and measure variation and how the data collected during the initial validation can support CPV (Continued Process Verification).

Regulatory agencies expect good understanding and control of process variation; don’t be left behind!

Speaker

  • Bob Hayes Vice-Chair, Pharmaceuticals Technical Activities Committee - Institution of Mechanical Engineers
9:50 am - 10:10 am

Annex 1 – Current & Future Deficiencies

The new Annex 1 is the ‘hottest’ regulatory topic currently. The recently introduced standard for sterile medicinal products significantly raises the regulatory requirements in a number of areas.
This presentation identifies those areas where Industry routinely failed to comply with the previous Annex 1 and looks ahead to predict the potential compliance ‘pitfalls’ within the revised guidance and how to avoid these.

This session offers a chance to consider sterile and cleanroom compliance from the perspective of a former MHRA steriles accredited inspector, before most companies will have been inspected against the new Annex 1.

Speaker

9:50 am - 10:10 am

Computer Software Assurance: FDA’s New Approach to Computer System Validation

A draft guidance of Computer Software Assurance (CSA) for Production and Quality System Software has been recently issued by the FDA. This new guidance, together with the second edition of the GAMP 5 guide, have shifted the emphasis away from indiscriminate scripted testing and documentation, towards more critical thinking and a risk based testing strategy. But CSA goes beyond the deployment of a particular methodology for testing strategy. It is more about a way of thinking about the management of computerized system, moving further towards a risk-based approach in all the aspects of their management.
Now that the new recommendations have been established, this practical session will cover the steps companies should take to align themselves optimally with the new CSA approach and take advantage of the opportunity to improve their software implementation and validation processes, spending less time on the mechanical aspects and getting better results.

Speaker

  • Sergi Arcas Senior Consultant and Area Manager - Rephine
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.

References
1. LCGC blog, 11/4/22. https://www.chromatographyonline.com/view/not-another-helium-crisis-
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. https://doi.org/10.17226/9860
4. Mineral Commodities Summaries 2023, US Geological Survey, US Department of the Interior. https://pubs.usgs.gov/periodicals/mcs2023/mcs2023.pdf

Speaker

  • Frank Judge Consultant Chemist - Chromatography - Butterworth Laboratories Ltd
9:50 am - 10:10 am

How do Engineers Prevent Non-Conformances?

Engineers have a key role in ensuring products, systems and processes meet quality requirements by being the ultimate problem-solvers… preventing problems before they happen! This talk will explore the role of engineers in quality risk management throughout the product lifecycle.

Speaker

10:00 am - 10:30 am

Trade Control Compliance – The Chemical Business Association’s Code of Conduct in Practice

To operate effectively in the modern day chemical and pharmaceutical supply chain companies need to have a good understanding of the possible uses and misuses to which the chemicals they are manufacturing, supplying, or using can be put.

There are several substances subject to strategic export controls (trade controls) on an international level but also nationally, such as EU and UK, which require differing degrees of paperwork and processes in place to ensure compliance. It is therefore vital that companies keep up to date with the changes to prevent delays, enforcement action or ‘bad press.’

In this presentation I will outline how CBA’s Code of Conduct on trade controls for chemicals is helping member companies not only understand their obligations and the requirements of the legislation, but also gives them practical advice on how they can put this into practise.

The presentation will provide a basic insight into aspects of:

  • What to do in practice
  • Legal Expectations
  • What security measures should be in place

 

Speaker

  • Karen Harvey Membership Manager - Chemical Business Association
10:00 am - 10:30 am

Using Technology to Scale the Distribution of Medical Product Donations Globally

Two billion people globally live without access to essential medicines. Healthcare companies want to do more to support communities but can be put off by the labour-intensive processes involved and the compliance risks posed.

Introducing, Boaz, a SaaS product that bridges the gap between healthcare companies and NGOs. Boaz makes managing the complexities of the product donation process easier to deliver more healthcare products to more people in need.

During its 20-year history to date, IHP has distributed medicines to 100 million people. Through Boaz, IHP invites pharmaceutical industry leaders to exponentially increase the scale of medical aid distribution, globally.

Speaker

10:00 am - 11:00 am

Workshop: Getting Started: Transitioning from Document-Centric to Data-Centric Drug Development

[vc_row][vc_column][vc_btn title="Book your place here" style="outline-custom" outline_custom_color="#000d66" outline_custom_hover_background="#000d66" outline_custom_hover_text="#ffffff" align="center" button_block="true" link="url:https%3A%2F%2Fwww.makingpharma.com%2Fworkshop-getting-started-transitioning-from-document-centric-to-data-centric-drug-development%2F|target:_blank"][/vc_column][/vc_row][vc_row][vc_column][vc_column_text]Pharma & Biotech companies around the world are now discussing a move from document-centric to data-centric development (document-centricity of course referring to pharma’s document-dependency).

However, even though companies want to move away from the document, or not be ‘document-centric’, fundamentally the industry still communicates through documents, sends information via documents etc. So, the solution (as we see it) is to not rely on the document as your source of knowledge. But, to index the content of the document, building an integrated knowledge base based on structured data frameworks where key information is Findable, Accessible, Interoperable & Reusable (FAIR). Once you have done this, the document becomes what it always should have been - an after-thought, not a priority.

In this workshop we’re going to explore a 3-step approach to indexing content (information), as opposed to indexing documents. We’ll discuss this through an example, a Quality Target Product Profile (QTPP), and we’ll look at how you might approach indexing the content of this typically huge, controlled document with the end result of building a digital-QTPP that is completely aligned with ICH Q8. Thereby shifting the point of scientific collaboration away from the document, and towards the data.

We hope that this workshop will provide new insight into the transition from document-centric development to data-centric development, and act as a source of inspiration to enact change at your respective organizations.[/vc_column_text][/vc_column][/vc_row]

Speaker

  • View full profile for Sana AhmedSana Ahmed Director of Quality by Design - QbDVision
10:10 am - 10:30 am

‘The Heat is On’ – Adapting Industry for Rising Temperatures

The talk will explore: Rising Global Temperatures and Future heatwaves; Some impacts including safety, performance and productivity; and adapting industry to cope.

Speaker

10:10 am - 10:30 am

A Wholly Automated Approach to Labelling and Packaging of Drug Product for Clinical Trials

This presentation will cover the Grand Challenge 2 Project (PACE – Pharmaceutical Automation for Clinical Excellence) which will be delivered as POC in 2 months’ time. The key components of this project are:

      • The modular design of PACE which allows, multiple drugs to be manufactured and packaged in the same facility without cross-contamination.
      • Layers of control from PLC to SCADA, to MES and finally there is a Real-time Qualified Person (QP) release dashboard which has been created to accelerate release of drug product.

Speaker

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.

Speaker

10:10 am - 10:30 am

Getting Our Procedures Right – Involving the End-User at the Writing Stage

Often we are given procedures to follow with no involvement in the content, how they are written and even if they make any sense to us. In this lively presentation we will cover the importance of involving the end-user in the design and wording of procedures, so that they are written in a style, language and way that the end-user understands. We will also cover how to check if a new procedure reflects reality, as sometimes they require actions that, in reality, cannot always be done that specific way.

Speaker

11:00 am - 11:40 am

GDP Requirements in Africa: An Exhilarating Journey!

Speakers

  • Fabrice Laval Senior Regional Manager for Africa and Middle East, International Agents - Cencora, World Courier
  • Tina Barton eMQT
11:30 am - 12:30 pm

KEYNOTE: Emerging Technologies Transforming and Reshaping Sustainability in Pharmaceutical Manufacturing

Speaker

11:30 am - 11:50 am

Product Traceability – Implementing Serialization as a Manufacturer

Speaker

11:30 am - 12:30 pm

Supply Chain Resilience in the Post-COVID Era

In the current dynamic landscape of disruptive challenges, ranging from geopolitical tensions to the spectre of inflation, firms are compelled to identify new levers to strengthen their Supply Chains (SC). At the same time, companies are required to pursue a twin transition, i.e. the simultaneous digital and “green” transformation. In this presentation, we will put forward i) a new definition of SC resilience in the new normal, ii) a practical SC resilience framework for evaluating and measuring SC resilience, and iii) the foundation and working method of a digital tool for the assessment of SC resilience within the manufacturing sector.

Speakers

11:30 am - 12:00 pm

Technology Trends & Opportunities in Robotics

Robot automation is already in use in the pharmaceutical sector with developments in AI, visualisation and autonomous mobile technologies now opening up new applications. This presentation reviews some of the typical applications and technology trends that will impact the pharmaceutical sector in the near future.

Speaker

  • Mike Wilson Chief Automation Officer - Manufacturing Technology Centre
11:30 am - 12:00 pm

Using Dissolution Imaging to Provide Insights in Various Pharmaceutical Systems

This presentation describes how UV dissolution imaging is being used to provide insights and mitigate against failure in its use in the determination of intrinsic dissolution rates and drug release from whole dosage forms. Several case studies reviewing the effects of various excipients in controlled release systems, solid dispersions, cocrystal systems and hot-melt extrusions formulations will be discussed.  Applications of UV imaging to non-oral formulations have started to emerge and will also be discussed.

This presentation will be of interest to excipient companies, and pharmaceutical companies working in the pre-formulation and formulation sectors.

Twitter: @dr_kasareaddo

Research group twitter: @AsareAddo_RG

Speaker

  • Dr Kofi Asare-Addo Reader, Department of Pharmacy School of Applied Sciences - University of Huddersfield
11:40 am - 12:10 pm

Sustainable Horizons: Pharma-Logistics on the Road to Net-Zero

Alan will provide an update on developments at the GDP-Universal Compliance Initiative and outline its plans for pharma-logistics to come together to pursue a decarbonisation program in pursuit of it's net-zero commitments.

Speaker

  • Alan Kennedy Executive Director - GDP-Universal Compliance Initiative
11:50 am - 12:10 pm

Electronic Leaflets and the Digital Twin

Speaker

12:00 pm - 12:30 pm

An Engineering Approach to Improving Essential Medicine Access – A Case Study on Liposomal Amphotericin B

Speaker

12:00 pm - 12:30 pm

Pharma 4.0 for Compliance Packaging Systems

The transformative impact of Pharma 4.0 on compliance packaging systems extends beyond next-level customer satisfaction, and unlocks new business models for pharmaceutical manufacturers. This presentation provides key insights into MTC’s cutting edge digital manufacturing research, comprising system integrations, digital twins, and computational intelligence to enable agile compliance packaging. This talk will showcase how Pharma 4.0 offers a framework for a holistic approach to cost-effective manufacturing systems that rapidly adapt to dynamic customer demands for personalised pharmaceutical tablet packaging. Thereby shaping a future where compliance packaging is highly customised and responsive to evolving regulatory requirements and market preferences.

Speaker

12:10 pm - 12:30 pm

Artwork and Labelling Management

Speaker

2:00 pm - 2:30 pm

Crafting a Gastric-Resistant Coating From Natural Ingredients: An Innovative Wax-Based Enteric Coating for Pharmaceutical and Nutraceutical Oral Products

Speaker

2:00 pm - 3:00 pm

How Are We Going to Balance Medicines Distribution With NHS Net Zero Targets?

Speaker

2:00 pm - 3:00 pm

ICH E6(R3) is Here: What Does This New GCP Guidance Mean for Clinical Research?

Speaker

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.

Speaker

2:00 pm - 4:00 pm

Sustainability, Reducing Carbon Footprint and Packaging

Speakers

2:30 pm - 3:00 pm

Applying the Manufacturing Classification System (MCS) to Continuous Processing

15:00

Speaker

  • Kendal Pitt Honorary Professor, Leicester School of Pharmacy - De Montfort University (DMU)
2:30 pm - 3:00 pm

Bridging Silos to Enable End-to-End Traceability: A Case Study in Optimising Pharmaceutical Batch Operations with Digital Transformation

In the pharmaceutical industry, outdated technology and fragmented systems have resulted in disjointed processes and increased potential for errors. Particularly in batch review and release, disparate systems hinder efficient data-exchange, leading to delays and inefficiencies.

This presentation highlights the need for integrated solutions to enable end-to-end traceability, emphasising the importance of breaking down silos and fostering cross-functional collaboration. We advocate for the adoption of emerging AI-based technologies to automate these processes, outlining their potential to streamline QA reviews, reduce regulatory risks, and deliver tangible benefits to organisations, fostering a more efficient and reliable industry. Case studies will be presented to illustrate this transformative impact.

Speaker

3:30 pm - 3:50 pm

Continuous Extrusion Granulation of Water Insoluble Drugs

15:50

Speaker

  • Prof. Dennis Doroumis Professor in Pharmaceutical Technology and Process Engineering - University of Greenwich
3:30 pm - 4:00 pm

Risk-Based Approaches in Auditing

Speaker

3:45 pm - 4:15 pm

A Focus on Amorphous Solid Dispersions

Speaker

3:45 pm - 4:05 pm

Application of GMP to ATMP Starting Material

Speakers

3:45 pm - 4:15 pm

Sustainability: A Way of Life in Our Industry?

Speaker

3:45 pm - 4:45 pm

Why is Quality Culture Critical To Manufacturing Success?

Organizational culture change is not something that is developed overnight or implemented via a set of instructions, nor is it something that can be changed by minor adjustments to a few people’s behaviors. It takes time and effort. Most importantly, it takes sustained commitment, unwavering dedication to an aligned approach, robust and constructive minimization of distractions, and rapid management of activities out of alignment with the cultural transition.

Speaker

3:50 pm - 4:10 pm

Pharmaceutical Cocrystals And Salts for Enhancing Solubility of Water Insoluble Drugs

Speaker

4:00 pm - 4:30 pm

GDP – The QMS and Data Integrity

Speaker

4:05 pm - 4:25 pm

GMP Quality Oversight of Your Investigational Medicinal Product

Do you have responsibility for the oversight of outsourced manufacture of Investigational Medicinal Products (IMP)?

This talk will introduce basic processes that support the qualification of contract manufacturers in your GMP supply chain. It will demonstrate sponsor oversight for effective management of risks associated with the manufacture of IMPs. Anonymised events at manufacturing sites that benefited from sponsor feedback by documented risk assessment will be given.

Start as you mean to go on. Make sound risk-based decisions when selecting vendors, confirming their GMP manufacturing process, and assessing events that occur during manufacturing by using a simple pragmatic quality system.

Speaker

4:10 pm - 4:30 pm

Continuous Manufacturing in Pharma: From Drug Crystallization to Inhalable Powders

Speaker

  • Clarinda Costa Sequeira Senior Postdoctoral Researcher - SSPC Research Centre, Bernal Institute, University of Limerick, Ireland
4:15 pm - 4:45 pm

Driving Sustainability in a Clinical Research Organisation

Speaker

4:15 pm - 4:45 pm

Taking Control of Controlled Release

Speaker

4:25 pm - 4:45 pm

Real Time Microbial Monitoring of Air and Water

Latest equipment developments that can see and report microbial bioburden in air and water as it happens, will be presented, with how it fits with Annex 1 compliance explained

Speaker

4:30 pm - 4:50 pm

Lipid Nanoparticles: An Effective Lipid-Based Technology

Speaker

  • Dr Md Mushfiq Akanda Senior Associate Pharmaceutical Development Scientist - Jazz Pharmaceuticals Research UK Limited
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