This PAT webinar will discuss strategies and methodologies for implementing TOC for cleaning system and cleaning process PAT.
The validation of cleaning systems and cleaning processes is costly both for initial testing and ongoing monitoring and revalidation. The application of Process Analytical Technology (PAT) provides tools that can provide real-time assurance of cleaning process operations within validated parameters, thus providing a means for effective, cost-efficient and successful risk assessment and management.
This presentation will provide effective strategies and methodologies for implementing TOC for cleaning system and cleaning process PAT. We will also discuss the use of PAT for the assessment and management of risk and the economic advantages of on-line analysis for a CIP skid.
Areas Covered in the seminar:
- How to implement real time assurance of cleaning process operations.
- How to provide effective strategies and methodologies for implementing TOC.
- How PAT provides effective, cost-efficient and successful risk assessment and management.
- Learning objectives:At the completion of this seminar, you will be able to:
- Discuss the cost savings with reduced validation efforts. Better understanding of your cleaning processes via collected analytical data.
- Identify the validation of cleaning systems and cleaning processes is costly both for initial testing and ongoing monitoring and revalidation.
- Summarize effective strategies and methodologies for implementation of TOC.
Who will benefit:
- Quality Assurance professionals and mangers
- Validation professionals, practitioners and mangers
- Operations professionals and mangers
- Engineering professionals and managers
- Regulatory professionals
Instructor Profile:
Keith Bader, is the Director of Technical and Quality Services at Hyde Engineering + Consulting, Keith is responsible for the implementation of quality and validation standards for Hyde Engineering + Consulting on a corporate wide basis. In addition, Keith serves as project manager for validation and engineering projects, as well as providing high level strategic consultation to Hyde Engineering + Consulting clients.
Since joining Hyde in 1999, as a Control Systems Engineer, Keith has gained experience on a variety of projects ranging from project engineering and commissioning to process and cleaning validation projects. Keith has worked on equipment ranging from stand-alone unit operations such as CIP and Ultrafiltration skids, to entire process trains.
Prior to joining Hyde, Keith was a Research Engineer at TDA Research in Wheatridge Colorado where he was responsible for the synthesis and testing of novel catalysts, and advanced ceramic composites. All of the work at TDA was funded by various government agencies, including NASA, DOE, and the EPA, through the SBIR program.
Keith earned his bachelor’s degree in Chemical Engineering from the University of Colorado at Boulder in 1995.