Implementing Process Analytical Technology
Can You Use PAT Successfully to Control Pharmaceutical Processes when Implementing Quality by Design?
Process analytical technology (PAT) is becoming a very important tool for controlling pharmaceutical processes and when implementing Quality by Design. As defined by the FDA, PAT is "a system for designing, analyzing, and controlling manufacturing through timely measurements (i.e., during processing) of critical quality and performance attributes of raw and in-process materials and processes with the goal of ensuring final product quality." As a scientific, risk-based framework, PAT is intended to support innovation and efficiency in pharmaceutical development, manufacturing, and quality assurance and is being seen as a very important tool for Quality by Design. The PAT framework is founded on process understanding to facilitate innovation and risk-based regulatory decisions by industry and the Agency.
This course is designed to help pharmaceutical manufacturing professionals chart a new course for innovation based on PAT. The course provides an overview to the tools and principles outlined in the FDA guidance, PAT - A Framework for Innovative Pharmaceutical Development, Manufacturing and Quality Assurance. Concepts to help organizations meet regulatory requirements for validating and controlling the manufacturing process are also provided.
Take Back to Your Job
- Explain the PAT framework and its concepts of process understanding and process control
- Understand the PAT tools and principles and how to apply them within your organization; how it can support the implementation of Quality by Design; and how it can be used for the new Process Validation approach
- Describe the regulatory processes open to firms who embrace the PAT framework
Attendance Recommended For
- Professional engineers, scientists and managers involved in pharmaceutical drug substance or drug product manufacturing and development, quality assurance, and regulatory affairs
- Facilities engineering and validation/commissioning service providers
Community of Practice (COP)
This training course is of particular interest to existing and future members of the ISPE Process Analytical Technology (COP). For further information, visit www.ISPE.org/COPs
Dr. Line Lundsberg-Nielsen is Senior QbD & PAT Consultant at NNE Pharmaplan and holds a Ph.D in NIR spectroscopy. She has many years of experience within the pharmaceutical industry and has a theoretical as well as practical approach to QbD and PAT from working at Novo Nordisk and Lundbeck before being a consultant. Line is involved from strategy development to practical implementation projects such as implementing PAT solutions, implementing QbD approaches, Science and Risk-based Verification, Process Verification to advanced Control Strategies. She chairs the ISPE PQLI Control Strategy team and is one of the co-authors of the ISPE PQLI® Guide Series – A Comprehensive Guide to Quality by Design from Concept to Continuous Improvement on how to implement Quality by Design, that will be published later this year.