Archives: Seminars

The Pharmaceutical Quality System (PQS) is always a focus of regulatory inspections, whether that be documentation, deviations, changes or CAPA effectiveness yet it is consistently an area of non-compliance observations. Why? The PQS should be seen as a holistic function with all individuals and teams operating in harmony to identify, impact assess and resolve deficiencies… Read more »

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.

Dominic has worked in the pharmaceutical industry since 1992 and is a leading pharmaceutical quality management specialist. Over the past 20 years he has worked as a leading pharmaceutical trainer and Quality Management System specialist. He is an IRCA registered GMP Lead Auditor and is Managing Director of Inspired Pharma Training.

Quality and cost are the two big drivers of the modern oral solid production. Mega batch and the continuous mini batch approach are two different ways to reach this goal. At first glance it seems that both solutions are completely the opposite of each other. With a closer look both solutions have a lot in… Read more »

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…. Read more »

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… Read more »

Compliance challenges can result in product quality issues, supply shortages and threats of regulatory action, which in turn puts increased pressure on a business and individuals. The need to maintain supply whilst trying to implement remediation and compliance improvement activities often results in competing priorities, aggressive timelines, and backlogs in the closeout of deviations and… Read more »

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… Read more »

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… Read more »

This presentation will cover the development of TiO2-free coating formulations in the pharmaceutical industry, driven by increasing regulatory scrutiny. Titanium dioxide (TiO2), traditionally used for its opacity and whiteness, faces regulatory challenges due to concerns for genotoxicity, including its classification as unsafe by EFSA when used as a food additive. We will compare various TiO2… Read more »