Why should you attend?
Increasing political and social pressures are forcing Life Sciences companies to manufacture affordable drugs that meet the existing requirements of patient safety, product quality and data integrity. Consequently, regulatory agencies are encouraging companies to meet these objectives through changing regulations that leverage progress in science and technology.
Over the years, auditors began to realize that the industry believed that producing voluminous documentation in support of validation would impress them. During their audits they noticed that often times companies lacked an understanding of the systems they were validating, thereby defeating the very purpose of validation. The new CSA approach being proposed focuses on critical thinking to obtain a good understanding of system risks, and the prevalent ways to mitigate them through validation.
This presentation will focus on applying CSA to the design, development and validation of a Manufacturing Automation System. The system operates in a multi-tiered functional hierarchy consisting of PLC’s, DCS and MES. The system realizes flexible manufacturing in a multiproduct facility where re-validation is not required for product changeovers.
- Regulatory expectations of CSA
- Fundamental differences between CSV and CSA
- The what and why of Flexible Manufacturing Systems
- Why the validation of Manufacturing Automation Systems (MAS) is a challenging task
- The regulations that MAS must satisfy
- How applying CSA to MAS satisfies data integrity requirements
Who will benefit?
- Quality Assurance/ Quality Control
- Product and Process Development
- Manufacturing Operations
- Regulatory Affairs
- Automation Engineers