Friday 12 June 2015

FDA PAT-Concept, Regulatory Impact


What is FDA PAT Initiative and how to comply with innovation requirements? Process Analytical PAT approach allows better focus to be placed on relevant multi-factorial relationships. It also serves as a basis for identifying and understanding relationships among critical formulation and process factors and for generating effective risk mitigation strategies (e.g., product specifications, process controls, training). The PAT mechanism for producing product quality & reducing waste presents a good case for utilizing continuous manufacturing technologies. What are the fundamental concepts behind the FDA PAT initiative and how PAT provides a good source of information for anyone involved in risk mitigation and regulatory compliance? Expert speaker Michael Levin provides answers to these queries in his webinar http://bit.ly/ProcessAnalyticalTechnology

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