Archives: Seminars

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… Read more »

The presentation will aim to illustrate the regulatory evolutions related to NAs, moving from general ones to nitroso APIs. The crucial point will be the analytical approach to the different matrices in function of the MDD of the drugs and the different limits foreseen for each impurity. The presentation will also include different case studies.

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… Read more »

Discrete Element Method (DEM) simulations offer a powerful tool for predicting the behaviour of bulk powder systems in pharmaceutical manufacturing. However, these simulations require accurate calibration, which typically relies on substantial material quantities. In the early stages of API development, only limited amounts of powder are available, posing a challenge for effective calibration. We propose… Read more »

In a scientific data driven sector we must transition our understanding and communication around sustainability from qualitative to quantitative. Quantifiable metrics and shared tools enable better communication and collaboration, which is vital considering most emissions lie in supply chains. To address this, we need good (not perfect) data available to access. We’ll give an overview… Read more »

Hydrogen peroxide (H2O2) is widely used in pharmaceutical manufacturing but presents significant safety challenges due to its reactive and hazardous nature. This presentation will focus on best practices for detecting and managing H2O2 exposure, ensuring worker safety and compliance. We will explore effective H2O2 detection methods, critical factors in selecting personal protective equipment (PPE), and… Read more »

The presentation will outline how to build and quality the facility, how to prepare for the licence application. How to obtain the licence. How to ramp up to routine production. Differences between sterile and non-sterile manufacture. Team requirements for a new facility. How to scope and budget the project and communicate to senior management. Common… Read more »

In an ever-evolving pharmaceutical market and a highly competitive employment landscape, it is crucial for individuals and organizations to stand out from the competition. Without a harmonized workforce, the core of these organizations, the “making” and “distributing” of pharmaceuticals can be affected. The purpose of this talk aims to provide valuable insights for attendees, offering… Read more »

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… Read more »

The Pharmaceuticals sector is, by its nature, highly regulated and CAPEX-friendly. These conditions are powerful drivers of quality and long-term progress but have the potential to suffocate daily operational improvement and stifle true manufacturing excellence. An antidote for this is having a truly effective Improvement Cycle embedded at the heart of operations. The Improvement cycle… Read more »