Auditing is a very important aspect of any Quality Management System, and is a specific requirement of both GMP and GDP. However, often audits are preformed as part of person’s very busy schedule, with limited planning and preparation for the audit itself, resulting in the audit not being as effective, efficient and professional as it… Read more »
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… Read more »
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… Read more »
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… Read more »
The Government of the United Kingdom (UK) introduced temporary measures to address problems with the supply of medicines to Northern Ireland in the wake of the UK’s withdrawal from the European Union (EU); both the UK and EU recognised that there were difficulties in operating the “Protocol on Ireland and Northern Ireland”, an agreement intended… Read more »
In this presentation, I will aim to explore the challenges and benefits associated with using a 3PL provider and choosing the right one. I then will explore the journey of the change from in-house warehousing to a 3PL. My discussion will span various considerations, from selecting the appropriate 3PL to the preparation and actual transition… Read more »
An introduction of the pharmaceutical supply chain and what happens to the product during the import and export process. The presentation would include the different stages and sub-contractors involved and how pharmaceutical distribution capabilities are different depending on carrier/GHA capability. The risk factors for each stage will be outlined and the part temperature management packaging… Read more »
In today’s dynamic and competitive business landscape, professional development has become an essential cornerstone for individual and organisational success. This presentation, titled “Navigating the Path to Success: Professional Development for Growth, Progression, and Succession,” delves into the critical strategies and practices required to ensure personal and organizational growth, progression, and smooth succession planning.
Changing the quality culture of a business “The pessimist complains about the wind. The optimist expects it to change. The leader adjusts the sails.” Identifying the common areas businesses struggle to get engagement • Input into quality events • Reviewing and understanding SOPs • Incorporating Quality into decision making Finding solutions to improve engagement •… Read more »
In this presentation, Dr. Enosh Mwesigwa will discuss the pressing need for complexity reduction in pharmaceutical formulations, through two insightful case studies. By embracing simplicity, for instance, through the adoption of multifunctional and high performance excipient technologies, formulators stand to benefit from streamlined processes, efficiency gains, and cost-effectiveness, and ultimately, increasing chances of earlier success… Read more »
23-24 April 2024
Coventry Building Society Arena
Step Exhibitions
Step House, North Farm Road
Tunbridge Wells, Kent
TN2 3DR, United Kingdom
Step Exhibitions Ltd does not, under any circumstances make attendee data available
to third parties for resale.