Improving procedures to enhance efficiency using Lean methodology
The landscape of clinical trials is changing. The recent Covid-19 pandemic did enhance those changes and the fast delivery of new vaccines made clear that we probably can work more efficient as an industry. Standard Operating Procedures are a key aspect in this. Reviewing them from a management and efficiency perspective will in most cases make a considerable difference in lead time and even in quality.
Our trainers Christy Boer, Andy Richardson and Berber Snoeijer are experienced in improving efficiency in procedures and do that from a Lean perspective. With this workshop we
– highlight the essence of the procedures,
– handle frequent efficiency issues in procedures according to the Lean principles
– discuss the ideal SOP system
– and introduce a methods for managers and team leaders to improve efficiency by evaluating and adjusting procedures.
For the roadmap we use Lean techniques and methods like APESS to involve the team members in improving the processes and to identify the possible efficiency issues. In addition we provide tips and techniques in how to create awareness and a mindset towards continuous improvement and change. The workshop is not meant to be a GxP quality assurance course. However as it is from the perspective of clinical trials, regulatory requirements and the normal practice in this are the basis of our workshop.
About the trainers:
Christy Boer graduated in 2004 in Analytical chemistry at ROC Eindhoven, The Netherlands. She has 15 years of experience within the food and pharmaceutical industry as an analyst. Since 2014, she has been responsible for optimizing processes and procedures. She has completed the Lean Management training, has further expanded her knowledge and was certified in 2016 for Quality Management. She creates awareness among managers and colleagues for the need of changing daily processes and procedures to improve efficiency and quality. With this she gives them the experience that adapting to procedures and processes can have a positive effect on efficiency and quality.
Andy Richardson is a pharmacologist by original training and has worked in the pharmaceutical and CRO sectors for many years. His key interests are in the area of clinical trial operational efficiency and he has experience supporting projects across all phases of the study lifecycle in the areas of data management, statistical programming, standards, computer systems validation and systems implementation. He co-leads the PHUSE Emerging Trends and Technology workgroup and is a key contributor to the PHUSE KPI project.
Berber Snoeijer graduated in biomedical sciences at Leiden university in 1996 and started in clinical research in 1997. During her career she has been the owner of a data driven CRO, set-up several different quality systems and improved processes as a manager and consultant. For efficient processes and use of the data, she experienced and used the skills of technical (software and database) engineering, process engineering and improving efficient utilization and interactions of people. Nowadays, as the owner of ClinLine, she uses these skills and her knowledge to assess, design and improve business solutions and processes for clients on smaller and larger scale.
Berber is an experienced manager, data engineer/scientist and SAS programmer/designer. She followed several dedicated training courses including TOGAF and Lean Green Belt. In addition, she has extensive knowledge on the use and implementation of Real World Data solutions.