INTELLIGENT AUTOMATION AND DIGITAL TRANSFORMATION IN QUALITY MANAGEMENT
[ Recorded Wednesday 9 December , 2020]
The Paperless Lab Academy® is glad to propose under the Academy Webinar Program, a presentation from Accenture about the new challenges faced in the Pharmaceutical Industry. Before the global pandemic, the industry was already facing problems of exploding drug development costs and increasingly complex supply chain and regulatory environments, as well as downward price pressure from generics, global health systems and outcome-based pricing models. The unprecedented challenges of the pandemic forcing remote work and demanding tests, vaccines and therapies at desperate speed, only add to the challenges. To date, Quality has throttled speed to market and been a necessary, but precious, cost. Today’s business cannot afford the reactive, manual and still largely paper-based Quality processes.
It is no longer enough to talk about digitalization and automation of antiquated Quality systems. It is now a business necessity to shift the Quality paradigm. Companies need to reduce the cost of Quality and increase the speed, efficiency, and reliability of our processes.
In this session, it will be discusses how companies can make this shift. Which challenges the industry must address, examples of real world progress, and road maps to adoption to help get your organization to the digital Quality future
Mary Mrowicki, Consulting Senior Manager at Accenture Scientific Informatics Services
Mary has worked in the life science industry for over 12 years, in both medical device and pharmaceuticals, with a specialization focus in Quality Management systems, including the Quality Control Labs. Mary holds a degree in Accounting and Management Information Systems.
Neil Fausz, Senior Manager at Accenture Scientific Informatics Services
Neil joined Accenture 3 years ago as a Senior Manager in Accenture’s Scientific Informatics business group and is based out of Miami, FL. Previously, he was responsible for Quality Management and Laboratory Informatics Systems at a Global CDMO and Life Sciences Pharmaceutical company. He has over 20 years of technology delivery and innovation experience across R&D, quality and manufacturing domains with a focus on ERP, QMS, DMS, LMS, and LIMS solu\ons. Neil holds a B.A. in International Relations and a B.S. in Business and Public Administration from the Missouri – Columbia.
Peter Brandstetter, Senior Manager at Accenture Scientific Informatics Services
Peter has experience across the fields of IT in the life sciences industry, in particular the pharmaceutical and medical devices sector. His areas of specialization are quality management and quality assurance in manufacturing and R&D (SAP QM,LIMS,ELN,QMS,ECM/DMS), clinical IT (clinical data management, pre-clinical, R&D Lab, R&D collaboration) and project management and computer valida\on. Peter has a M.Sc. degree in computer
sciences from the University of Linz, Austria.
The Pharmaceutical sector faces unprecedented challenges from the Covid-19 pandemic. Increase in specific product demand is reshaping supply chains and driving fundamental changes to the nature of the pharmaceutical industry and the products it manufactures.
Against this backdrop, Accenture is helping Pharmaceutical Quality Control Labs better manage volatility and variability in product supply and quality testing. Within QC labs, there is a wealth of instrumentation collecting information, and that information needs to drive batch release decisions. By focussing on the digitization of the laboratory and manufacturing operations we can provide a more effective decision support for both the labs and qualified persons, with a focus on reducing the overall amount of time that the sample spends in the lab.
Attend this session and learn more about:
- Sharpening the curve in the lab getting batches out the door at a quick and consistent pace by connecting the lab through the internet of lab things (IoLT), providing an end-to-end data strategy, enhancing the human experience, and enabling a network of labs to communicate
- Achieving significant cycle-time reduction by applying digital lean principles to improve scheduling and capacity planning
- Unlocking the value of lab data when it is digitalized as well as correlated with other aspects of the manufacturing process
- Enabling digital tracking of products from the packaging line through to the patient. Our team specialises in systems that digitally track and document the production process, providing the groundwork for more automated and analytics-driven manufacturing and supply chains
We’ll discuss how our team is helping clients gather data and facilitate an electronic batch record, resulting in less stress, and less time to release the batch. This presentation and discussion will explore the imperative for digital transformation in the context of the pharmaceutical laboratory, plant and supply chain – all in the context of the exceptional times and new digital normal we are all adapting to.
One hour free Online presentation includes Q&A session with the presenter
Access to the recorded session for the registrees
Accenture’s Scientific Informatics Services business group combines scientific and laboratory informatics expertise with strategic and business consulting capabilities, industry platforms, innovation approach and global scale to revolutionize how scientific and laboratory processes are conducted. We work with our clients to streamline technology and processes, and harness the power of data, to remain competitive within today’s changing scientific informatics ecosystem.