MP-B Seminars

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.

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.

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

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.

This presentation explores labeling compliance strategies in the pharmaceutical industry, focusing on the critical role of automated proofreading to ensure labelling accuracy.

Accurate labelling is essential for compliance with regulatory requirements, safeguarding patient safety, and preventing counterfeiting. Despite these important factors as well as the availability of automated proofreading tools, many Pharmaceutical companies are still relying on reviewing and proofreading their labelling documents manually. Automated proofreading tools streamline the verification process, reduce the risk of errors in text and graphics and ensure that labels meet stringent regulatory standards. By integrating automated solutions, companies can enhance the efficiency and reliability of their labelling processes, ultimately protecting patients from potential harm and maintaining the integrity of their products in a competitive and highly regulated market.

This presentation looks at the key challenges in packaging complex medicines like biologics, gene therapies, and new mRNA drugs. It highlights the challenges of deep freezing in gene therapies and discusses the risks from leachables extractables, which can change the pH of complex pharmaceuticals. These changes can lead to issues like protein clumping, the creation of solid particles, and the inactivation of important drugs, such as monoclonal antibodies. Addressing the importance of evaluating different specialty packaging options during early stability studies to reduces these risks and ensure that the drugs remain effective throughout their lifecycle.

Merging implementation science with smart pharmaceutical packaging can revolutionize both healthcare and sustainability. Implementation science, which focuses on translating research into real-world practice, ensures that smart packaging solutions—such as RFID-enabled systems for monitoring dosage adherence—are effectively adopted by healthcare providers and patients. When designed with sustainability in mind, these technologies reduce waste through precise inventory management, limit the need for excess production, and promote the use of eco-friendly materials. This approach not only improves patient outcomes but also aligns pharmaceutical practices with environmental sustainability goals. So, I would like to address the implementation science for the audience to bring more ideas and techniques to the smart packaging and to give insights of reducing the gap of 17 years needed to bring new medical ideas from research to the pharmaceutical market! Smart packaging benefits both pharmacists and patients by enhancing medication management and improving safety. For pharmacists, it facilitates better control over medication dispensing, preventing errors. For patients, features like digital reminders, adherence tracking, and interactive information through QR codes or NFC technology help ensure proper dosage and timely consumption. Combined, these tools support better health outcomes and foster more efficient pharmaceutical services.

This presentation will cover challenges and opportunities in advanced medicine manufacturing exploring the practical application of latest, proven technologies. 

Real life examples will provide an insight in what will be the norm in future medicine manufacturing.  This in part comes from assessing and adoption of practices from other industries. 

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 CAPAs. This presentation will help attendees to see the wood for the trees by providing some practical examples of how to use risk management to identify and prioritise the most important actions and maintain perspective critical to GMDP compliance.