Phase-Appropriate GMPs: A Regulatory Roadmap

This webinar will focus on current best practices for mapping the regulatory framework during R&D, investigational phases, and to commercial manufacturing.  Taking a proactive approach to exploring what control strategies are expected, and subsequently required, will provide a streamlined development approach ensuring the safety and quality of the product. A phase-appropriate cGMP operating model is highly relevant for companies that have a high level of externalization of their R&D and early investigational development activities. This approach is characterized by an accumulation of product/process knowledge, increasing application of good manufacturing practices, and escalating quality controls across the product lifecycle.