29 April 2025 Seminars

The manufacturing of 3D printed personalised medicines at the point of care (PoC) is expected to revolutionise the pharmaceutical sector. Here we present a range of 3D printing technologies that offer significant benefits in comparison to conventional manufacturing processes including rapid print times, automation, print accuracy, excellent palatability and medication adherence. The clinical evaluation of 3D printed medicines has shown that PoC manufacturing can improve patient treatment and wellbeing. In addition, 3D printing offers continuous manufacturing of medicines at affordable cost for a children and elderly patients. The presentation includes some regulatory aspects that should be considered for the design of printable medicines.

Guardtech Group Commercial Director Mark Wheeler will outline the most critical elements of any new cleanroom construction project, beginning with key documentation, performance specification and process flow before moving on to thoughts on personnel, product considerations and regulatory compliance. The focus will then shift on to the host building, health & safety concerns, future proofing and project prioritisation, as well as touching on some of the Guardtech Group's best Pharmaceutical cleanroom builds in the past 5 years.

The NHS 2050 net zero target requires a fundamental rethink in most pharmaceutical manufacturing processes. While the benefits of single use systems are significant in sterile processing, the sourcing, manufacturing, distribution, use and disposal of the products ultimately results in an environmental impact. Taking a lifecycle view when re-designing our products is key to achieve net zero targets.

Calum will discuss the application of full life cycle assessments in reducing environmental impact while retaining the desired performance.

A look at how successful companies have adapted and adopted ideas from other industries and the opportunities this approach offers pharma.

Virtual wholesaling and traditional wholesaling differ in terms of operational efficiency and accessibility. In traditional wholesaling, the RP (Responsible Person) has full oversight of physical inventory and oversees distribution activities directly from warehouses or supply centres.

In virtual wholesaling, the distribution activities are undertaken remotely, and the operations rely heavily on 3rd party suppliers to physically hold and move their products. Virtual wholesaling offers flexibility, a broader market reach and less overhead, however, the RP must still ensure compliance with pharmaceutical regulations and reliable logistics partners to maintain product integrity through a secure supply chain.

How does a virtual RP maintain the right level of oversight in these different business models?

All segments of the Pharmaceutical Supply Chain must remain attentive to their environmental footprint, encompassing the stages of development, manufacturing, marketing, utilization, and disposal or excretion of medications. This workshop will facilitate group activities and discussions, allowing participants to examine the current challenges and opportunities associated with the sustainable delivery of pharmaceuticals.

Choosing the Most Suitable Sample Points for Particle and Microbial Monitoring – A Risk Based Analysis

This paper will start by explaining the difference between cleanroom classification and monitoring. It then considers EU GMP Annex 1 and looks at ways to select the correct viable and non-viable sample point locations when considering the installation of a Facility / Environmental Monitoring System in an aseptic manufacturing facility. Looking at what is reviewed in risk assessments, it then follows a journey through the process to illustrate a methodology of how sample points are defined and finishes with some practical examples.

The importance of eco-friendly excipients in promoting sustainability within the pharmaceutical industry cannot be overstated. Traditional excipients, while effective, often come with significant environmental footprints due to their synthetic origins, the chemicals used in their production, and the energy-intensive manufacturing processes involved. These conventional practices can contribute to pollution, resource depletion, and other ecological issues.

July 2022, NHS the first health care system which has introduced the net zero into legislation. Which means by 2045 to reduce the zero carbon footprint on all medicines. In this presentation we will look at regular excipients vs sustainable excipients and how you can reduce your carbon footprint.

What are self inspections?
Why are they so important?
Who should carry out self inspections?
How to conduct an effective self inspection
How do companies get them wrong?
What to do with outputs
Recording a self inspection
Common MHRA inspection findings relating to self inspection
How to respond to MHRA findings examples (good practice/bad practice

This presentation will provide an overview of the challenges in the virtual wholesaling and how to plan for a successful launch of product within the market.
To enter the market, companies need not just an Approved Marketing Authorisation but also a licensed supply chain, including authorisations for importation, batch release, and distribution.
This session will focus on the distribution aspect of a market launch by a virtual wholesaler with a review of the challenges :
- Planning the Wholesale Distribution strategy
- Setting up a Virtual Wholesale Operation
- Sourcing product and Launch challenges
- Challenges of managing supply chain integrity and patient safety
- Outsourced Activities

Classical Microbiology methods for Environmental Monitoring of air, or for looking at CFU’s from Water takes time (5 days or more) and has a very low recovery rate. Real time and rapid microbiological methods (RMM) are now encouraged by Annex 1 and can give an immediate response to the presence of bioburden. So you can “see now and react now” to excursion events as they happen or you can trend bioburden and be sure you are in control continuously.

We are at the dawn of a new era for laboratories and those working in them. The value output of labs is at the edge of being transformed by the opportunities presented by data systems, automation, smart technology, AI and machine learning.

The impacts of the growth of these technologies will be felt in all aspects of lab operations including people, skills, locations and buildings.

I will discuss:

- Change, adaptation and flexibility in the laboratory estate
- Smart data systems
- The business case for automation
- The vital role of design to foster collaboration across the labs landscape.

• Sustainability begins to dominate the global agenda and truly is urgent.
• The consumer continues to look for immediate gratification. Last mile deliveries become the norm and more organised.
• Consumers look for individual approach, Globalisation continues to erode.
• Supply chains forced to think differently about how to optimise at smaller local scale with much less waste.
• Regulators wake up and realise that more and more documentation does not help transparency or quality and efficacy. Simple automation is the key.
• More practical approach to managing risk is led by the consumer healthcare industry and pharma become late adopters due to higher risk profile and less consumer facing demands.
• OTC consolidates in the same way FMCG has with fewer players owning a larger share.

This presentation will explore the development of long-acting drug delivery systems designed to improve patient adherence in the treatment of chronic diseases. The focus will be on the design of injectable, in situ forming implants based on dual-stimuli responsive nanogels and solid drug nanoparticles. These nanocomposite drug depots enable controlled, long-term release by responding to body temperature and physiological conditions upon injection. The talk will cover the underlying polymer chemistry, formulation challenges, and pre-clinical evaluation of these systems, which hold the potential to enhance therapeutic outcomes by addressing poor adherence in chronic disease treatments

Some self-inspection programmes fail to adequately appraise the effectiveness and applicability of the PQS leaving the company unwittingly exposed to the risk of non-compliance and adverse regulatory action. This presentation will offer some practical tips on how to avoid gaps between self-inspection and regulator findings by considering aspects of self-inspection focus, training, and post audit activity, to help to improve the effectiveness of self-inspection programmes and support maintaining an “inspection ready” status by providing confidence that GMDP requirements are being met.

In this presentation, the MTC will showcase a range of advanced automation and digital capabilities that have been developed to support the sector, with a particular focus on customisation. To further advance the use of technology in the pharmaceutical industry, we will also discuss an exciting new collaborative Laboratory Automation programme, which is currently in development and offers opportunities for input and collaboration.

We’ll explore the transformative journey of implementing the My Green Lab program at AstraZeneca, a globally recognized certification that fosters sustainability within laboratory environments. The My Green Lab initiative not only engages employees in sustainable practices but also drives the development of innovative projects that contribute to cost savings and the efficient use of natural resources. By highlighting successful case studies and quantifiable outcomes, we will demonstrate how My Green Lab empowers our workforce to become active participants in environmental stewardship. Join us to learn how this program is reshaping our commitment to sustainability and generating tangible benefits for both our company and the planet.

Advancement's in CCIT to semi-automate/fully automate integrity testing and it's results. Removing non-deterministic methods and replacing with valid, data backed, deterministic test methods that meet Annex 1, FDA, PDA , 21 CFR compliance and ASTM standards.
Sharing understanding on statistical sampling and requirements to 100% inspect.

It is well recognised that a significant hurdle to the adoption of innovative technologies is that regulations and guidelines do not always keep pace with rapid developments in science and technology. This presentation will consider the challenges with regulating new technologies and explore how Regulators globally are adapting to do more than just keep pace with these advances as they seek to becoming pro-innovation and built closer partnerships with industry pioneers.

An explanation of the ways criminals commonly attempt to infiltrate the supply chain. For example, through domain impersonation, WDA hijacking, supplying medicines which have knowingly been stored incorrectly/stolen, supplying products which are completely falsified and not manufactured to proper (or any!) standards.
Despite being one of the most important responsibilities, not all attempts can be publicised at the time of occurrence as it can jeopardise ongoing investigations/prosecutions. This presentation will have anonymised, real-life scenarios of concluded investigations, to show that it is not just a theoretical threat.

This presentation will summarise AstraZeneca’s sustainability strategy, it’s Life Cycle Assessment programme for commercial products, and how we are integrating LCA principles into development projects through new innovative tools.

Digitalisation of processes is inevitable to remain competitive and improve performance. However, without a proper strategy to implement digital Quality processes, the benefits of the transformation could be limited and the adoption slow and sometime counterproductive.

This presentation will provide some guidance for companies on how to step back and be more strategic about how they look at Quality System digitalisation, starting with the digital maturity assessment.

High-pressure homogenization is commonly used by pharmaceutical and nutraceutical industries globally to tailor the sizes and PDIs of various formulations (liposomes, solid lipid nanoparticles (SLNs), nanoemulsions, and nanosuspensions) at a commercial scale. The current study aims to highlight the case studies for different formulations and their appropriate processing conditions to tailor the sizes and PDIs with enhanced stability and good drug entrapment efficiency.
Various trials were performed to formulate liposomes, SLNs, nanoemulsions, and nanosuspensions using model drugs (hydrophilic & hydrophobic). A comparison of piston gap (PG) and microchannel devices (MCDs) was performed at varying processing conditions (pressures/number of passes). In the case of MCDs, different microchannels (Y & Z) were compared to check their efficiency for tailoring the desired particle size distributions with reliability.
In some of the cases, MCD results were found to be better than PG and in others; a combination of PG and MCD demonstrated significant results with desired particle size distributions and drug entrapment efficiency. But both of these technologies (PG & MCD) have their significance, as PG is less likely to be blocked than MCD, but the issue of MCD blocking can be overcome by back flushing. The viscosity of the formulation is also one of the major factors in HPH processing of the formulations, but the use of a pressure feed vessel may help to some extent in resolving this issue; similarly for processing of SLNs thermocirculator is attached to the assembly to achieve desired results.

A presentation in general about what happens when companies fail to maintain quality, the risks to patients, the catastrophic risk to the companies (in many cases they have closed) and how you can protect yourself, patients and respond if things do go bad.

Intending to include a section on the MHRA Inspection Action Group, and how to best deal with any critical deficiency.

Having created a culture of sustainability across our lab spaces, we are looking towards the future of sustainability and what that means to the pharmaceutical industry. We will look at how the cultural shift has empowered the workforce to identify opportunities and drive innovative change through the organisation, leveraging automation, digitalisation and new ways of working to improve our efficiencies and our sustainable ways of working

The workshop will cover cleanroom design, cleanroom standards, cleanroom testing and validation, and also touch on sustainability and some of the work that is being done in this area.

Biopharma pipelines are potent. Effective [highly] potent drug safety management is critical whether managing compliance and liability or in developing new processes and facilities. The workshop will cover key technical and commercial aspects of potent drug safety whether as drug substances or drug products and include the following:

Toxicological hazard assessment
Biopharmaceutical occupational health and safety risk assessments
Containment and Control - Engineering, Procedural and Personal

Come along and bring your most difficult questions!

With global freight increasing and supply chain disruptions on the rise, the pressure on cold chain transportation has never been higher. Managing temperature-sensitive logistics can seem overwhelming, as a single misstep can result in product loss and financial disaster. However, with expert guidance, you can successfully navigate these challenges. John Coleman, Business Unit Director for YSDS Life Science, brings 20 years of experience in cold chain logistics, quality assurance, and risk assessment. In this 45-minute session, he’ll guide you through the cold chain process, teaching you how to create validated logistics solutions, avoid delays, reduce temperature deviations, and mitigate risks.

Particle adhesion force plays a critical role in powder handling operations and processes. There are many widely used methods, such as atomic force microscopy (AFM) and centrifugal detachment. However, most methods have limitations when the measurements are correlated to the bulk behaviour of powders, such as powder flow with varied particle size distributions. The study focuses on a unique test technique for measuring forces between particles and surfaces using cohesive powders, which includes a mechanical surface energy tester developed at The Wolfson Centre. The work focuses on predicting the powder flow function using a novel technique in conjunction with common particle attributes, with the goal of predicting flowability problems at an early stage of formulation using only a small amount of powder sample.

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

The presentation will discuss the thermal modelling/simulation tools that are currently available and used to support analysis and testing within pharmaceutical temperature-controlled supply-chain. What considerations must be considered for model characterisation and accuracy. How thermal modelling/simulation is currently used and what could be potential uses in the future. Finally, a review of the benefits of using simulation within your supply-chain operations.

In it’s drive to reduce assessment times for submissions, MHRA is requiring better quality submissions and reducing the opportunity to correct errors. From January 2024 Parallel Import licence variations were only allowed one RFI cycle and from summer 2024 new MA applications for Established Medicines were also limited to a single RFI cycle. It seems inevitable that applications for new PI licences will soon only be allowed one RFI cycle. 

This presentation will highlight less obvious aspects of the application which can cause problems and highlight probably the only up to date and comprehensive guide to the UK PI process. 

This interactive session will provide an overview of the key regulatory changes, recently implemented, relating to the manufacture, importation, supply and control of medicines, within the UK, from a GxP and compliance perspective. The impact of future key changes, driven by the MHRA, EU, US FDA, ICH etc, currently awaiting implementation or under discussion, will also be assessed.

An ideal session for those wishing to recap on the implementation of the ‘Windsor Framework’ and check they haven’t missed any upcoming regulatory changes.

Radiopharmaceuticals play a crucial role in diagnosing and treating diseases like cancer. Given their short half-life, transporting these materials involves complex logistical challenges that demand swift delivery, rigorous safety protocols, and flawless execution. In his presentation, Peter Smith, Senior Vice President Life Couriers UK, will emphasize the importance of precise labelling, thorough documentation, and trained personnel. He will also showcase flexible contingency planning and share real-life examples from Life Couriers to illustrate how critical deliveries are safely and reliably completed.

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.

The role of the QP in pharmaceutical supply is often seen as an expensive necessity. A ‘hired pen’. It is regularly referred to as a ‘releasing QP’ role, which is miles from the truth under current legislation.

I’ll be talking about the breadth of the QP role, and why it is essential that QPs are not just sitting at a desk releasing batches. I’ll also explain what companies should expect to get when they hire a QP- regardless of whether they are permanent or a consultant.