In this role Gene is providing the vision, strategy and management of the laboratory informatics product portfolio that includes the Electronic Laboratory Notebook, Laboratory Information Management System and the Laboratory Execution system.
Gene has been working in the Life Science industry for over 20 years developing robotic and Laboratory informatics systems.
1. What are you looking forward to discussing with the audience?
The focus of our discussion will be the typical challenges that come along with paper based and/or disconnected processes in the Quality Testing context. We will give an overview of the possibilities and capabilities of the BIOVIA Quality Testing solution and show the benefits of moving to an electronic Quality Testing solution. We will also analyze how they can tie into contributing to the overall goals of an organization.
2. You’ve mentioned that quality operations are typically a bottleneck and considered to include many non-value add activities for the drug manufacturing process. Can you explain why?
Studies at drug manufacturing companies have shown that the average time for Quality Control/Quality Assurance activities is typically almost double the time an organization spends on actual production processes. This is largely due to organizations relying on paper based and disconnected processes which are difficult to manage and make adherence to regulations more challenging and resource consuming. In addition, many quality testing systems are not integrated with an inventory solution making even more manual data entry work. These inefficiencies lead to non-value add waiting times for the release of raw materials used in the production process as well as to waiting and high inventory costs by a delayed release of finished products.
3. Is this topic only relevant for roles that are directly engaged in working with Quality Testing?
Quality Testing should actually be seen in the larger context of an organization’s Total Quality Strategy. Many capabilities play into the successful management and execution of Quality. This includes for example, the definition, documentation, submission, monitoring and management of quality related activities and tasks as well as the execution of quality tests. The BIOVIA approach will support the FDA mandate for deeper integration of Quality into end-to-end operations to design quality into products and processes as well as foster a quality culture across all areas of an organization from discovery to commercialization.
4. What do you hope the audience will learn from this webinar?
By attending this webinar, I hope the audience will see the true potential impact of eliminating paper from their Quality Testing processes and how that positively affects their bottom line.
Join Gene Tetreault in BIOVIA’s Webinar ‘Building Compliance and Operational Excellence into your Quality Lab Operations’ on 19 May at 4pm London/11am New York