Process Analytical Technologies (PAT) is the wave of the future for the pharmaceutical industry. 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, essentially, about improving processes for effectiveness and efficiency, which leads to the application of lean Six Sigma.

Lean Six Sigma for FDA's PAT Initiatives Course Objectives

• Explain the PAT framework and the concepts of process understanding and process control.
• Understand the PAT tools and principles and how to apply them.
• Describe the regulatory process open to firms who embrace the PAT framework.
• Understand lean Six Sigma and what it can do to cut costs and increase profits.
• Explain the differences between Six Sigma and lean manufacturing.

Lean Six Sigma for FDA's PAT Initiatives Topics

• PAT principles and tools
• Multivariate tools for design, data acquisition, and analysis
• Process analyzers
• Process control tools
• Continuous improvement/knowledge management
• Adapting the concept of lean and Six Sigma to pharmaceuticals
• Lean and Six Sigma tools

Who Should Attend Lean Six Sigma for FDA's PAT Initiatives?
Recommended for management and key staff members in research and development, quality assurance, manufacturing, regulatory affairs, and other cross-functional team members involved with pre- and post production of pharmaceutical products. Learn how lean and Six Sigma tools can play an important role in the application of PAT.