Quality by Design

Lifecycle Process Validation (PV) remains one of the most important and commonly misunderstood topics in the pharmaceutical industry. How many lots should I make? Are we taking enough samples? Do we need to use statistics in our protocols? The real question may be: am I even focusing on the right questions? Course participants will focus on the practical application of the lifecycle approach to all stages of PV to gain valuable knowledge and insight on the regulations, guidance, and best practices currently utilized across the industry. This classroom course is relevant to individuals working throughout the pharmaceutical product lifecycle in....

Substantial business benefits are emerging from industry when Quality by Design (QbD) principles are used for new and existing drug products yielding reduced operating costs, enabling significantly more efficient manufacturing processes and better positioning companies to meet increasing regulatory expectations. For example, the completion of ICH Guidelines, Q8 (R2): Pharmaceutical Development, Q9: Quality Risk Management and Q10: Pharmaceutical Quality System and the recent USFDA guidance on Process Validation contain recommendations for building and capturing process knowledge and understanding and establishing a strategy for process control during Stage 1, process design. There is evidence from 483s and warning letters that FDA....

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....