ISPE CEUs: 1.3
Type: Classroom Training Course
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 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 also are provided.
This training course is of particular interest to existing and future members of the ISPE Process Analytical Technology Community of Practice (COP).
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This course can be offered at your company site in its current format or customized to meet the needs of your organization.