Join TIBCO Software for a complimentary workshop and learn how TIBCO has been helping pharmaceutical organizations such as BIOGEN and SHIRE Pharamaceuticals mitigate the risks of being non-compliant.
This interactive workshop will demonstrate how TIBCO’s validated industry-standard analytics platform enables organizations to:
- Reduce risk in quality harmonization initiatives
- See how an effective monitoring system provides assurance of the continued capability of processes and controls to meet product quality and to identify areas for continual improvement (CPV) – ICH Q10 Guidance
- Deliver auditable workflows and reports for regulated manufacturing
- Satisfy FDA decrees for GxP process monitoring and Process Analytical Technology (PAT) compliance
- Register today and see how embracing an analytics-driven model will enable your organization to optimize innovation.
12:00- 01:00 Registration/Lunch
1:00 –1:15 Welcome
1:15 – 2:00 Next Generation Biologics Manufacturing: Delivering the Vision
Timothy Alosi, Head Global Data Analytics, BIOGEN
Learn the business drivers behind Biogen's Next Generation Manufacturing, as well as the role of advanced controls and data analytics. The presentation will focus on the critical role that data systems play, specifically Tibco Statistica, and the key functions enabled by the data systems.
2:00-2:45 Statistica and Continuous Process Verification
Danny Stout,Ph.D., TIBCO Software
Discover the tool that has over 16,000 functions and numerical validation packages including the functionality to support CPV that are fully functional for out-of-the-box adoption without the need to re-validate.
3:00 – 3:45 Advanced Biopharmaceutical Manufacturing Genealogy Analysis and Visualization with TIBCO Statistica
Robert Dimitri, Associate Director Manufacturing Systems, Shire
Native ERP system reports often lack full genealogy information for complex Biopharmaceutical manufacturing processes. While it may be possible to execute multiple queries or reports and manually construct useful genealogy datasets, such a process is inefficient and prone to errors. This presentation demonstrates how TIBCO Statistica was used to solve this problem by reading and processing transactional ERP data into meaningful information in support of process monitoring, investigations and audits, and process understanding for the Shire Massachusetts Biologics sites.
3:45- 4:30 Digitalization of Life Sciences and Healthcare
Chris L. Waller, Ph.D.Vice President, Chief Scientist, EPAM Systems, Inc.
For over 20 years, the Life Sciences Business Unit of EPAM has been working with leading Life Science companies to deliver sophisticated scientific informatics and innovative enterprise technology solutions to meet diverse needs spanning the Research and Development continuum. This talk will focus on our vision for the digital research enterprise, our experience with the TIBCO product suite in this regard, and trends that we are seeing that will necessitate changes to our technology offerings.
4:30-4:45 pm Closing Remarks