Education Sessions
E-RC4
Challenges in Implementing Manufacturing Execution System (MES) and Electronic Batch Record (EBR) Solutions
| 7 November 9.00 – 12.00 | Track: Regulatory / Compliance |
ISPE CEUs: 0.3
As a result of the emphasis on manufacturing excellence, MES implementations have become more commonplace. Now, manufacturers are finding ways to leverage EBR in the product work release process in addition to enhancing compliance. In order to enhance the quality related review process a key concept is review by exception . This concept helps minimize labor costs as well as reduce the release time cycle.
Further, a significant portion of the batch record data is generated by the PCS. Frequently the data provided are difficult to integrate into an EBR solution. By suitable restructuring of the PCS generated data it becomes feasible to implement a complete EBR solution.
This session will discuss emerging technologies in the MES and EBR arena and provide guidance about developing key user requirements. Practical approaches to implement integrated EBR solutions and how EBR can be leveraged in the work release process will be discussed.
Take Back to Your Job
- Insight into how the industry is utilizing MES to support and expedite product release
- Understand EBR and ‘Release by Exception’
- Explain why and how PCS data restructuring is essential for integrated EBR implementation
Who Should Attend
Manufacturing Engineers, Quality Control Specialists, QA Managers, Regulatory Affairs Specialists, and Technical Service personnel that are involved in the QA and QC support for product manufacturing.
Session Leaders
- John Hannon, Principal, Computer Sys., Commissioning Agents Inc
- Veda Walcott, Director of Quality, Cook Pharmica LLC
Session Speakers
- Robert Brokamp, Dir Automation Services, Jacobs Engineering Group Inc
- Chinmoy Roy, Senior Automation Engineer, Genentech
- John Sever, President, Cascade Controls