United Podcast Network
Implementing Quality Metrics for Validation w/Ivan Soto
On today’s episode, Stacey Bruzzese welcomes back Ivan Soto, Director Manufacturing Validation Emergent BioSolutions. Stacey and Ivan talk about the current challenges with the implementation of quality metrics for validation.Stacey and Ivan discuss:What current challenges are companies facing when implementing new metrics?Which metrics have proved to be the most useful?FDA Guidance on Submission of Quality Metrics DataHow quality metrics help us understand the lifecycle of equipmentWhat do companies need to know when implementing metrics programs for validation?How can we account for supply chain elements?How will our current systems adapt to handle technological changes?What role will the FDA continue to play in oversight?Ivan has been in the life science industry for over 20 years and held several technical and management positions at different Pharmaceutical companies in the areas of Validation, IT Compliance, Quality Control and Quality Assurance. In his previous role under his leadership, his team successfully implemented a lean validation program. He is an active speaker at conferences related to validation cost reduction and efficiency improvements. He is also a contributing editor for the Journal of GxP Compliance and Validation Technology. He has a (B.S) in Chemistry from the Catholic University of Puerto Rico.Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
Duration: 30 min