Implementing Process Analytical Technology Training Course (T29)
Process analytical technology (PAT) is becoming a very important tool for controlling pharmaceutical processes and when implementing Quality by Design. As defined by the USFDA, 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 training course is designed to help pharmaceutical manufacturing professionals chart a new course for innovation based on PAT.
What You Will Learn
- 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
Resources and Activities
- Pre-Course Work Materials
- Interactive Exercises
- Learning Assessments
Who Should Attend
Additional Course Details
Community of Practice (COP)
This training course is of particular interest to existing and future members of the ISPE Process Analytical Technology & Lifecycle Control Strategy Community of Practice (COP).